Improve Sudden Cardiac Arrest Study
Sponsor
Medtronic Cardiac Rhythm and Heart Failure (Industry)
Overall Status
Completed
CT.gov ID
NCT02099721
Collaborator
(none)
4,222
93
6
54.2
45.4
0.8
Study Details
Study Description
Brief Summary
The purpose of this study is to demonstrate that primary prevention patients with one or more additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent pre-ventricular contractions (PVCs), and low left ventricular ejection fraction (LVEF)) are at a similar risk of life-threatening ventricular arrhythmias (LTVA) when compared to secondary prevention patients, and would receive similar benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Devices allowed in the study include any Medtronic single, dual, or triple chamber defibrillator that has received appropriate license or regulatory approval and is commercially available by Medtronic in the geography in which the implant will take place. Any market-released, commercially available lead(s) can be used in the study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
4222 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Improve Sudden Cardiac Arrest Study
Actual Study Start Date
:
Mar 1, 2014
Actual Primary Completion Date
:
Jul 15, 2018
Actual Study Completion Date
:
Sep 5, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group A: Secondary prevention patients- device implant Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant. |
Device: ICD or CRT-D Device
Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
| No Intervention: Group B: Secondary prevention patients - no device implant Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects choose not to receive an ICD/CRT-D implant. |
|
| Active Comparator: Group C: 1.5 Prevention patients - device implant Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. |
Device: ICD or CRT-D Device
Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
| No Intervention: Group D: 1.5 prevention patients - no device implant Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects choose not to receive an ICD/CRT-D implant. |
|
| Other: Group E: Primary, non-1.5 patients - device implant Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects receive an ICD/CRT-D implant. |
Device: ICD or CRT-D Device
Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
| No Intervention: Group F: Primary, non-1.5 patients - no device Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects choose not to receive an ICD/CRT-D implant. |
Outcome Measures
Primary Outcome Measures
- Time to the First Occurrence of a Ventricular Arrhythmia [Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month VT-VF rate (as compared in the Outcome Measure table between Groups A and C).]
Time to the first occurrence of an episode of true ventricular tachycardia or fibrillation 24 Month rates will be provided for the two groups used in the primary endpoint definition. However, the primary endpoint of hazard ratio is presented in Statistical Analysis 1 as a ratio between Groups A and C.
Secondary Outcome Measures
- Mortality [Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month mortality rate (as compared in the Outcome Measure table between Groups C and D).]
Time to all-cause mortality
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject has a Class I indication for implantation of an ICD according to the American College of Cardiology (ACC)/American Heart Association(AHA)/Heart Rhythm Society (HRS) or European Society of Cardiology (ESC) Guidelines
-
Subject (or subject's legally authorized representative) is willing and able to sign and date the Patient Informed Consent Form.
Exclusion Criteria:
-
Subject is ≤ 18 years of age
-
Subject with any exclusion criteria as required by local law (e.g., age, pregnancy, breast feeding)
-
Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader
-
Subject has any contraindication for ICD/CRT-D
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Churruca | Buenos Aires | Argentina | ||
| 2 | Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | ||
| 3 | Hospital Universitario Fundación Favaloro | Buenos Aires | Argentina | ||
| 4 | Instituto Cardiovascular de Buenos Aires (ICBA) | Buenos Aires | Argentina | ||
| 5 | Republican Scientific and Practical Center "Cardiology" | Minsk | Belarus | ||
| 6 | Real e Benemérita Associação Portuguesa de Beneficência | São Paulo | Sao Paulo | Brazil | 01322 |
| 7 | INCOR - Hospital das Clínicas da Faculdade de Medicina da USP | Sao Paulo | Brazil | 5403-900 | |
| 8 | INCOR - Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo | Brazil | ||
| 9 | Anhui Provincial Hospital | Hefei | Anhui | China | 230001 |
| 10 | Xiamen Heart Center | Xiamen | Fujian | China | 361004 |
| 11 | Wuhan Asia Heart Hospital | Wuhan | Hubei | China | 430022 |
| 12 | The Third Xiangya Hospital of Central South University | Changsha | Hunan | China | 410013 |
| 13 | Nanjing First Hospital | Nanjing | Jiangsu | China | 210006 |
| 14 | Wuxi Peoples Hospital | Wuxi | Jiangsu | China | 214023 |
| 15 | The First Hospital of Jilin University | Changchun | Jilin | China | 130021 |
| 16 | First Hospital of Dalian Medical University | Dalian | Liaoning | China | |
| 17 | The General Hospital of Shenyang Military Region | Shenyang | Liaoning | China | 110016 |
| 18 | Shanghai Changhai Hospital | Shanghai | Shanghai | China | 200433 |
| 19 | West China Hospital, Sichuan University | Sichuan | Sichuan | China | 610041 |
| 20 | The First Teaching Hospital of Xinjiang Medical University | Urumqi | Xinjiang | China | 830054 |
| 21 | First People's Hospital of Yunnan Province | Kunming | Yunnan | China | 650032 |
| 22 | The First Affiliated Hospital of Zhejiang University College of Medicine | Hangzhou | Zhejiang | China | 310003 |
| 23 | Hangzhou First People's Hospital | Hangzhou | Zhejiang | China | 310006 |
| 24 | The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China | 325027 |
| 25 | Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | China | ||
| 26 | The Second Xiangya Hospital of Central South University | Changsha | China | ||
| 27 | The Second Affiliated Hospital of the Third Military Medical University | Chongqing | China | ||
| 28 | Fujian Provincial Hospital | Fuzhou | China | 350001 | |
| 29 | Sun Yat-Sen Memorial Hospital Sun Yat-Sen University | Guangzhou | China | 510000 | |
| 30 | The First Affiliated Hospital of Sun Yat-Sen Medical University | Guangzhou | China | 510000 | |
| 31 | Guizhou Province People's Hospital | Guiyang | China | ||
| 32 | The First Affiliated Hospital of Zhejiang University College of Medicine | Hangzhou | China | 310003 | |
| 33 | The Second Affiliated Hospital of Zhejiang University College of Medicine | Hangzhou | China | ||
| 34 | Zhejiang Greentown Cardiovascular Hospital | Hangzhou | China | ||
| 35 | The Second Affiliated Hospital of Harbin Medical University | Harbin | China | 150001 | |
| 36 | Jinhua Municipal Central Hospital | Jinhua | China | ||
| 37 | Jiangsu Province People's Hospital | Nanjing | China | 210029 | |
| 38 | Ruijin Hospital of Shanghai Jiaotong University School of Medicine | Shanghai | China | 200025 | |
| 39 | Renji Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | China | 200127 | |
| 40 | Xinhua Hospital Shanghai Jiaotong University School of Medicine | Shanghai | China | ||
| 41 | Zhongshan Hospital Fudan University | Shanghai | China | ||
| 42 | Shenzhen Sun Yat-sen Cardiovascular Hospital | Shenzhen | China | 518001 | |
| 43 | The First Affiliated Hospital of Soochow University | Suzhou | China | ||
| 44 | The First Affiliated Hospital Of Xi'an Jiaotong University | Xi'an | China | 710061 | |
| 45 | Fundacion Cardioinfantil | Bogota | Colombia | ||
| 46 | Wadi El-Neel Hospital | Cairo | Egypt | ||
| 47 | Care Hospital | Hyderabad | Andhra Pra | India | |
| 48 | Medanta- The Medicity | Gurgaon | Haryana | India | |
| 49 | Ruby Hall Clinic | Pune | Maharashtr | India | |
| 50 | King George's Medical University | Lucknow | Uttar Prad | India | 226003 |
| 51 | BM Birla Heart Research Centre | Kolkata | W Bengal | India | 700027 |
| 52 | Care Institute of Medical Sciences (CIMS) | Ahmedabad | India | ||
| 53 | Post Graduate Institute of Medical Education & Research | Chandigarh | India | 160012 | |
| 54 | Lisie Hospital | Cochin | India | 682018 | |
| 55 | B.M. Birla Heart Reserch Centre | Kolkata | India | 700027 | |
| 56 | BM Birla Heart Research CentreB | Kolkata | India | 700027 | |
| 57 | All India Institute of Medical Sciences | New Delhi | India | ||
| 58 | Govind Ballabh Pant Hospital | New Delhi | India | ||
| 59 | Krishna Institute of Medical Sciences (KIMS) | Secunderabad | India | ||
| 60 | Sejong Hospital | Bucheon-Si | Korea, Republic of | ||
| 61 | Dong-A University Hospital | Busan | Korea, Republic of | 602-812 | |
| 62 | Keimyung University Dongsan Medical Center | Daegu | Korea, Republic of | ||
| 63 | Chonnam National University Hospital | Gwangju | Korea, Republic of | ||
| 64 | Seoul National University Bundang Hospital | Gyeonggi-Do | Korea, Republic of | ||
| 65 | Asan Medical Center | Seoul | Korea, Republic of | ||
| 66 | Korea University Anam Hospital | Seoul | Korea, Republic of | ||
| 67 | Severance Hospital | Seoul | Korea, Republic of | ||
| 68 | The Catholic University of Korea Seoul Saint Mary's Hospital | Seoul | Korea, Republic of | ||
| 69 | Institut Jantung Negara - National Heart Institute | Kuala Lumpur | Malaysia | ||
| 70 | Universiti Malaya Medical Centre | Kuala Lumpur | Malaysia | ||
| 71 | Hospital Angeles Lomas | Leon | Guanajuato | Mexico | 37150 |
| 72 | Hospital Angeles Lomas | Huixquilucan de Degollado | Mexico | 52763 | |
| 73 | Hospital Angeles Leon | Leon | Mexico | ||
| 74 | Hospital General de Puebla | Puebla | Mexico | ||
| 75 | Russian Scientific Center of Surgery by B.V. Petrovkiy, RAMN | Moscow | Russian Federation | 119991 | |
| 76 | Russian Scientific Center of Surgery by B.V. Petrovskiy, RAMN | Moscow | Russian Federation | ||
| 77 | Novosibirsk Research Institute of Circulation Pathology | Novosibirsk | Russian Federation | 630055 | |
| 78 | Scientific Research Institute of Cardiology | Tomsk | Russian Federation | 634012 | |
| 79 | Tyumen Regional Clinical Hospital | Tyumen | Russian Federation | 625023 | |
| 80 | Tyumen Cardiology Center | Tyumen | Russian Federation | 625026 | |
| 81 | Tyumen Cardiology Center | Tyumen | Russian Federation | ||
| 82 | Tyumen Regional Clinical Hospital | Tyumen | Russian Federation | ||
| 83 | Changi General Hospital | Singapore | Singapore | ||
| 84 | National Heart Centre Singapore | Singapore | Singapore | ||
| 85 | Groote Schuur Hospital | Cape Town | South Africa | ||
| 86 | Kaohsiung Veterans General Hospital | Kaohsiung | Taiwan | ||
| 87 | China Medical University Hospital | Taichung | Taiwan | ||
| 88 | Taichung Veterans General Hospital | Taichung | Taiwan | ||
| 89 | National Taiwan University Hospital Hsin Chu Branch | Taipei | Taiwan | 10002 | |
| 90 | National Taiwan University Hospital | Taipei | Taiwan | ||
| 91 | Taipei Veterans General Hospital | Taipei | Taiwan | ||
| 92 | Military Hospital | Montfleury | Tunisia | ||
| 93 | Dubai Hospital | Dubai | United Arab Emirates |
Sponsors and Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
Investigators
- Principal Investigator: Shu Zhang, Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:
NCT02099721
Other Study ID Numbers:
- Improve SCA
First Posted:
Mar 31, 2014
Last Update Posted:
Oct 28, 2020
Last Verified:
Oct 1, 2020
Keywords provided by Medtronic Cardiac Rhythm and Heart Failure
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group A: Secondary Prevention Patients- Device Implant | Group B: Secondary Prevention Patients - no Device Implant | Group C: 1.5 Prevention Patients - Device Implant | Group D: 1.5 Prevention Patients - no Device Implant | Group E: Primary, Non-1.5 Patients - Device Implant | Group F: Primary, Non-1.5 Patients - no Device |
|---|---|---|---|---|---|---|
| Arm/Group Description | Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis. | Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects chose not to receive an ICD/CRT-D implant. | Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis. | Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects chose not to receive an ICD/CRT-D implant. | Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis. | Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects chose not to receive an ICD/CRT-D implant. |
| Period Title: Overall Study | ||||||
| STARTED | 1066 | 127 | 1068 | 845 | 331 | 452 |
| COMPLETED | 990 | 0 | 983 | 774 | 304 | 432 |
| NOT COMPLETED | 76 | 127 | 85 | 71 | 27 | 20 |
Baseline Characteristics
| Arm/Group Title | Group A: Secondary Prevention Patients- Device Implant | Group B: Secondary Prevention Patients - no Device Implant | Group C: 1.5 Prevention Patients - Device Implant | Group D: 1.5 Prevention Patients - no Device Implant | Group E: Primary, Non-1.5 Patients - Device Implant | Group F: Primary, Non-1.5 Patients - no Device | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis. | Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects choose not to receive an ICD/CRT-D implant. | Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis. | Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects choose not to receive an ICD/CRT-D implant. | Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis. | Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects choose not to receive an ICD/CRT-D implant. | Total of all reporting groups |
| Overall Participants | 1066 | 127 | 1068 | 845 | 331 | 452 | 3889 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
57.1
(14.3)
|
55.7
(15.5)
|
61.1
(11.7)
|
59.1
(13.3)
|
61.3
(11.3)
|
57.8
(13.7)
|
59.0
(13.3)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
254
23.8%
|
27
21.3%
|
253
23.7%
|
176
20.8%
|
95
28.7%
|
103
22.8%
|
908
23.3%
|
| Male |
812
76.2%
|
100
78.7%
|
815
76.3%
|
669
79.2%
|
236
71.3%
|
349
77.2%
|
2981
76.7%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||||
| Asian Indian |
159
14.9%
|
23
18.1%
|
115
10.8%
|
273
32.3%
|
44
13.3%
|
239
52.9%
|
853
21.9%
|
| Black or African |
7
0.7%
|
0
0%
|
8
0.7%
|
2
0.2%
|
3
0.9%
|
1
0.2%
|
21
0.5%
|
| Chinese |
529
49.6%
|
97
76.4%
|
595
55.7%
|
475
56.2%
|
158
47.7%
|
182
40.3%
|
2036
52.4%
|
| Korean |
229
21.5%
|
4
3.1%
|
158
14.8%
|
25
3%
|
50
15.1%
|
15
3.3%
|
481
12.4%
|
| Other Asian |
35
3.3%
|
1
0.8%
|
28
2.6%
|
50
5.9%
|
9
2.7%
|
5
1.1%
|
128
3.3%
|
| White or Caucasian |
85
8%
|
2
1.6%
|
119
11.1%
|
10
1.2%
|
52
15.7%
|
4
0.9%
|
272
7%
|
| Other Race |
17
1.6%
|
0
0%
|
42
3.9%
|
10
1.2%
|
14
4.2%
|
5
1.1%
|
88
2.3%
|
| Not reportable per local laws or regulations |
1
0.1%
|
0
0%
|
1
0.1%
|
0
0%
|
1
0.3%
|
0
0%
|
3
0.1%
|
| Subject/physician chose not to provide information |
4
0.4%
|
0
0%
|
2
0.2%
|
0
0%
|
0
0%
|
0
0%
|
6
0.2%
|
| Region of Enrollment (participants) [Number] | |||||||
| Colombia |
11
1%
|
0
0%
|
25
2.3%
|
0
0%
|
6
1.8%
|
0
0%
|
42
1.1%
|
| Argentina |
27
2.5%
|
0
0%
|
33
3.1%
|
1
0.1%
|
21
6.3%
|
0
0%
|
82
2.1%
|
| Singapore |
14
1.3%
|
5
3.9%
|
42
3.9%
|
76
9%
|
23
6.9%
|
27
6%
|
187
4.8%
|
| Egypt |
6
0.6%
|
2
1.6%
|
1
0.1%
|
1
0.1%
|
1
0.3%
|
1
0.2%
|
12
0.3%
|
| Malaysia |
45
4.2%
|
0
0%
|
23
2.2%
|
30
3.6%
|
0
0%
|
0
0%
|
98
2.5%
|
| United Arab Emirates |
3
0.3%
|
0
0%
|
3
0.3%
|
1
0.1%
|
5
1.5%
|
0
0%
|
12
0.3%
|
| Belarus |
8
0.8%
|
0
0%
|
7
0.7%
|
1
0.1%
|
1
0.3%
|
0
0%
|
17
0.4%
|
| India |
149
14%
|
22
17.3%
|
104
9.7%
|
263
31.1%
|
39
11.8%
|
236
52.2%
|
813
20.9%
|
| Russia |
21
2%
|
0
0%
|
46
4.3%
|
0
0%
|
24
7.3%
|
0
0%
|
91
2.3%
|
| South Korea |
232
21.8%
|
4
3.1%
|
160
15%
|
25
3%
|
52
15.7%
|
15
3.3%
|
488
12.5%
|
| China |
385
36.1%
|
85
66.9%
|
545
51%
|
359
42.5%
|
144
43.5%
|
136
30.1%
|
1654
42.5%
|
| Taiwan |
125
11.7%
|
9
7.1%
|
18
1.7%
|
72
8.5%
|
1
0.3%
|
29
6.4%
|
254
6.5%
|
| Brazil |
9
0.8%
|
0
0%
|
6
0.6%
|
0
0%
|
0
0%
|
0
0%
|
15
0.4%
|
| Mexico |
3
0.3%
|
0
0%
|
17
1.6%
|
9
1.1%
|
5
1.5%
|
4
0.9%
|
38
1%
|
| South Africa |
5
0.5%
|
0
0%
|
9
0.8%
|
2
0.2%
|
3
0.9%
|
1
0.2%
|
20
0.5%
|
| Tunisia |
22
2.1%
|
0
0%
|
28
2.6%
|
5
0.6%
|
6
1.8%
|
3
0.7%
|
64
1.6%
|
| Malta |
1
0.1%
|
0
0%
|
1
0.1%
|
0
0%
|
0
0%
|
0
0%
|
2
0.1%
|
Outcome Measures
| Title | Time to the First Occurrence of a Ventricular Arrhythmia |
|---|---|
| Description | Time to the first occurrence of an episode of true ventricular tachycardia or fibrillation 24 Month rates will be provided for the two groups used in the primary endpoint definition. However, the primary endpoint of hazard ratio is presented in Statistical Analysis 1 as a ratio between Groups A and C. |
| Time Frame | Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month VT-VF rate (as compared in the Outcome Measure table between Groups A and C). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Implanted 1.5 primary prevention and implanted secondary prevention patients. Since the primary objective is the hazard ratio of implanted 1.5 patients to implanted secondary patients, Groups B, D, E and F are not compared for this outcome. While not the primary endpoint, 24-month rates are provided to illustrate the underlying data. |
| Arm/Group Title | Group A: Secondary Prevention Patients - Device Implant | Group C: 1.5 Prevention Patients - Device Implant |
|---|---|---|
| Arm/Group Description | Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis. | Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis. |
| Measure Participants | 1053 | 1068 |
| Number (95% Confidence Interval) [Estimated 24-Month VT-VF Pct of Patients] |
32.5
|
18.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A: Secondary Prevention Patients - Device Implant, Group C: 1.5 Prevention Patients - Device Implant |
|---|---|---|
| Comments | H0: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) ≤ 0.70 HA: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) > 0.70 | |
| Type of Statistical Test | Equivalence | |
| Comments | The equivalence margin is a hazard ratio significantly above 0.70. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.47 | |
| Confidence Interval |
(2-Sided) 95% 0.38 to 0.57 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The hazard ratio, estimated by a Cox proportional hazard model, has time to first treated VT/VF for 1.5 Prevention in the numerator, with Secondary Prevention in the denominator. | |
| Title | Mortality |
|---|---|
| Description | Time to all-cause mortality |
| Time Frame | Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month mortality rate (as compared in the Outcome Measure table between Groups C and D). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Implanted and not-implanted 1.5 primary prevention patients. Since the secondary objective is the hazard ratio of implanted 1.5 patients to not-implanted 1.5 patients, Groups A, B, E and F are not compared for this outcome. While not the secondary endpoint, 24-month rates are provided to illustrate the underlying data. |
| Arm/Group Title | Group C: 1.5 Prevention Patients - Device Implant | Group D: 1.5 Prevention Patients - no Device Implant |
|---|---|---|
| Arm/Group Description | Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis. | Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects choose not to receive an ICD/CRT-D implant. |
| Measure Participants | 1068 | 845 |
| Number (95% Confidence Interval) [24 Mo. Mortality Rate (Pct. of Patients)] |
12.1
|
18.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group A: Secondary Prevention Patients - Device Implant, Group C: 1.5 Prevention Patients - Device Implant |
|---|---|---|
| Comments | The null hypothesis is that the hazard ratio of implanted to non-implanted 1.5 patients = 1. The alternative is that the ratio is not equal to 1. | |
| Type of Statistical Test | Superiority | |
| Comments | A hazard ratio significantly below 1 indicates reduced mortality in the 1.5 implanted group. | |
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | The p-value is for the effect of treatment group on time to death, adjusting for the baseline covariates of age, gender, QRS duration, ischemic cardiomyopathy, LBBB, NYHA classification, diabetes, LVEF, syncope, NSVT and PVCs. | |
| Method | Wald chi-square | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.51 | |
| Confidence Interval |
(2-Sided) 95% 0.40 to 0.66 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Multiple imputations were employed to account for missing baseline covariates. | |
Adverse Events
| Time Frame | Baseline through approximately 42 months of follow-up | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed | |||||||||||
| Arm/Group Title | Group A: Secondary Prevention Patients - Device Implanted | Group B: Secondary Prevention Patients - No Device Implanted | Group C: 1.5 Prevention Patients - Device Implant | Group D: 1.5 Prevention Patients - No Device Implant | Group E: 1.0 Prevention Patients - Device Implant | Group F: 1.0 Prevention Patients - No Device Implant | ||||||
| Arm/Group Description | Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis. | Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects did not receive an ICD/CRT-D implant. | Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis. | Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects did not receive an ICD/CRT-D implant. | Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have none of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis. | Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have none of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects did not receive an ICD/CRT-D implant. | ||||||
All Cause Mortality |
||||||||||||
| Group A: Secondary Prevention Patients - Device Implanted | Group B: Secondary Prevention Patients - No Device Implanted | Group C: 1.5 Prevention Patients - Device Implant | Group D: 1.5 Prevention Patients - No Device Implant | Group E: 1.0 Prevention Patients - Device Implant | Group F: 1.0 Prevention Patients - No Device Implant | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 33/371 (8.9%) | 0/18 (0%) | 24/220 (10.9%) | 24/173 (13.9%) | 3/76 (3.9%) | 4/71 (5.6%) | ||||||
Serious Adverse Events |
||||||||||||
| Group A: Secondary Prevention Patients - Device Implanted | Group B: Secondary Prevention Patients - No Device Implanted | Group C: 1.5 Prevention Patients - Device Implant | Group D: 1.5 Prevention Patients - No Device Implant | Group E: 1.0 Prevention Patients - Device Implant | Group F: 1.0 Prevention Patients - No Device Implant | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 88/371 (23.7%) | 0/18 (0%) | 72/220 (32.7%) | 37/173 (21.4%) | 20/76 (26.3%) | 10/71 (14.1%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 1/173 (0.6%) | 1 | 2/76 (2.6%) | 2 | 0/71 (0%) | 0 |
| Hypereosinophilic syndrome | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Cardiac disorders | ||||||||||||
| Cardiac Failure | 8/371 (2.2%) | 8 | 0/18 (0%) | 0 | 21/220 (9.5%) | 30 | 2/173 (1.2%) | 3 | 5/76 (6.6%) | 5 | 0/71 (0%) | 0 |
| Congestive cardiomyopathy | 3/371 (0.8%) | 3 | 0/18 (0%) | 0 | 17/220 (7.7%) | 20 | 1/173 (0.6%) | 1 | 4/76 (5.3%) | 5 | 1/71 (1.4%) | 1 |
| Ventricular tachycardia | 17/371 (4.6%) | 21 | 0/18 (0%) | 0 | 2/220 (0.9%) | 2 | 3/173 (1.7%) | 4 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Cardiac failure congestive | 6/371 (1.6%) | 7 | 0/18 (0%) | 0 | 5/220 (2.3%) | 7 | 3/173 (1.7%) | 8 | 3/76 (3.9%) | 4 | 2/71 (2.8%) | 2 |
| Atrial Fibrillation | 2/371 (0.5%) | 2 | 0/18 (0%) | 0 | 5/220 (2.3%) | 5 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Ischaemic cardiomyopathy | 2/371 (0.5%) | 3 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 1/173 (0.6%) | 1 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Arrhythmia | 3/371 (0.8%) | 4 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Atrial flutter | 3/371 (0.8%) | 3 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Cardiac arrest | 2/371 (0.5%) | 2 | 0/18 (0%) | 0 | 2/220 (0.9%) | 2 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Ventricular extrasystoles | 2/371 (0.5%) | 3 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Acute myocardial infarction | 2/371 (0.5%) | 2 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 2/173 (1.2%) | 2 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Cardiac failure acute | 2/371 (0.5%) | 2 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 2/173 (1.2%) | 2 | 0/76 (0%) | 0 | 1/71 (1.4%) | 1 |
| Coronary artery disease | 2/371 (0.5%) | 3 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Ventricular fibrillation | 2/371 (0.5%) | 2 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Myocardial infarction | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 2/173 (1.2%) | 2 | 0/76 (0%) | 0 | 1/71 (1.4%) | 1 |
| Angina pectoris | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Brugada syndrome | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Cardiac amyloidosis | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Cardiac tamponade | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Sinus tachycardia | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Supraventricular tachycardia | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Cardiopulmonary failure | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Extrasystoles | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Myocardial ischaemia | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 5/173 (2.9%) | 5 | 0/76 (0%) | 0 | 1/71 (1.4%) | 1 |
| Ventricular flutter | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||||||||
| Hypertrophic cardiomyopathy | 2/371 (0.5%) | 2 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Hydrocele | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Eye disorders | ||||||||||||
| Cataract | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Macular cyst | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Gastric ulcer | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 2/220 (0.9%) | 2 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Haemorrhoids | 2/371 (0.5%) | 2 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Constipation | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Diarrhoea | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Dieulafoy's vascular malformation | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Gastric ulcer haemorrhage | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Ileus | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Inguinal hernia | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Vomiting | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Dyspepsia | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 1/71 (1.4%) | 1 |
| Gastrointestinal haemorrhage | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 2/173 (1.2%) | 2 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Gastrointestinal perforation | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| General disorders | ||||||||||||
| Death | 5/371 (1.3%) | 5 | 0/18 (0%) | 0 | 2/220 (0.9%) | 2 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Asthenia | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Chest pain | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Dystrophic calcification | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Impaired hearing | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Medical device site swelling | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Multiple organ dysfunction syndrome | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Peripheral swelling | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Sudden cardiac death | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Chest discomfort | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||
| Cholecystitis | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Cholecystitis acute | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Hepatic failure | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Infections and infestations | ||||||||||||
| Pneumonia | 5/371 (1.3%) | 8 | 0/18 (0%) | 0 | 4/220 (1.8%) | 4 | 5/173 (2.9%) | 5 | 0/76 (0%) | 0 | 2/71 (2.8%) | 2 |
| Septic shock | 3/371 (0.8%) | 3 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Liver abscess | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 2/220 (0.9%) | 3 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Urinary tract infection | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 2 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Influenza | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 2/220 (0.9%) | 2 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Medical device site abscess | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 2 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Medical device site infection | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Sepsis | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Upper respiratory tract infection | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 2 | 0/71 (0%) | 0 |
| Bronchiolitis | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Device related infection | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Diverticulitis | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Endocarditis | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Implant site infection | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Medical device site cellulitis | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Pharyngitis | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Pseudomembranous colitis | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Staphylococcal bacteraemia | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Tinea faciei | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Wound infection staphylococcal | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Gangrene | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Skin infection | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 1/71 (1.4%) | 1 |
| Urosepsis | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||
| Patella fracture | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Scapula fracture | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Spinal compression fracture | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Sternal fracture | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Tibia fracture | 1/371 (0.3%) | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 | |
| Vascular graft occlusion | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Wrist fracture | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Vascular pseudoaneurysm | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Investigations | ||||||||||||
| Blood glucose increased | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Investigation | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Liver function test abnormal | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| Diabetes mellitus | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Fluid overload | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Gout | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Hyperkalaemia | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Hyponatraemia | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Hypophagia | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Rheumatoid arthritis | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Hepatocellular carcinoma | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 3 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Cholangiocarcinoma | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 2 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Basal cell carcinoma | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Benign salivary gland neoplasm | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Bladder cancer | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Gastric cancer | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Lung neoplasm malignant | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Malignant neoplasm of unknown primary site | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Neurogenic tumour | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Non-small cell lung cancer | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Prostate cancer | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Tongue neoplasm malignant stage unspecified | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Acute myeloid leukaemia | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Benign gastric neoplasm | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Bladder cancer recurrent | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Lung cancer metastatic | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Syncope | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 4/220 (1.8%) | 4 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Cerebral infarction | 3/371 (0.8%) | 3 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Hypoxic-ischaemic encephalopathy | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Ischaemic stroke | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Cerebrovascular accident | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Dizziness | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Embolic stroke | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Hemiplegia | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Loss of consciousness | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Paraesthesia | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Cerebral haemorrhage | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 1/71 (1.4%) | 1 |
| Product Issues | ||||||||||||
| Lead dislodgment | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Device lead issue | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Device pacing issue | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Psychiatric disorders | ||||||||||||
| Delirium | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Suicide attempt | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||
| Acute kidney injury | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 3/220 (1.4%) | 3 | 1/173 (0.6%) | 1 | 1/76 (1.3%) | 1 | 1/71 (1.4%) | 1 |
| Chronic kidney disease | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| End stage renal disease | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Haematuria | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Ureteric stenosis | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||
| Benign prostatic hyperplasia | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 1/76 (1.3%) | 1 | 0/71 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Pneumonia aspiration | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 2/220 (0.9%) | 2 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Asthma | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Bronchiectasis | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 2 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Chronic obstructive pulmonary disease | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Dyspnoea | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Haemoptysis | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Pleural effusion | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Pneumothorax | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Pulmonary congestion | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Pulmonary mass | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Surgical and medical procedures | ||||||||||||
| Heart transplant | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Medical device change | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Mitral valve replacement | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 1/71 (1.4%) | 1 |
| Vascular disorders | ||||||||||||
| Aortic dissection | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Brachiocephalic vein stenosis | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Haematoma | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 1/220 (0.5%) | 1 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Hypertension | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Orthostatic hypotension | 1/371 (0.3%) | 1 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 0/173 (0%) | 0 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Circulatory collapse | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
| Steal syndrome | 0/371 (0%) | 0 | 0/18 (0%) | 0 | 0/220 (0%) | 0 | 1/173 (0.6%) | 1 | 0/76 (0%) | 0 | 0/71 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| Group A: Secondary Prevention Patients - Device Implanted | Group B: Secondary Prevention Patients - No Device Implanted | Group C: 1.5 Prevention Patients - Device Implant | Group D: 1.5 Prevention Patients - No Device Implant | Group E: 1.0 Prevention Patients - Device Implant | Group F: 1.0 Prevention Patients - No Device Implant | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||
Limitations/Caveats
The IMPROVE SCA trial was an non-blinded post-market trial that was not randomized. Thus baseline variables will differ across the treatment groups. Covariate adjustments were made in the analyses as a result.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Katy Muckala, Sr. Clinical Research Specialist |
|---|---|
| Organization | Medtronic CRHF |
| Phone | (763) 526-1767 |
| katy.a.muckala@medtronic.com |
Responsible Party:
Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:
NCT02099721
Other Study ID Numbers:
- Improve SCA
First Posted:
Mar 31, 2014
Last Update Posted:
Oct 28, 2020
Last Verified:
Oct 1, 2020