LSS of 4-SITE: Longitudinal Surveillance Study of the 4-SITE Lead/Header System

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01596595
• Collaborator: (none)
• Enrollment: 1,820
• Locations: 111
• Actual Duration (Months): 82.5
• Patients Per Site: 16.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header.

Condition or Disease	Intervention/Treatment	Phase
Primary Prevention of Sudden Cardiac Arrest; Secondary Prevention of Sudden Cardiac Arrest

Detailed Description

The objective of the LSS of 4-SITE Study is to prospectively determine the chronic complication-free rate of the 4-SITE Lead/Header System in order to verify its clinical performance, long-term reliability and functional integrity. The LSS of 4-SITE Study is a non-randomized, multi-center, global clinical investigation of subjects implanted with the 4-SITE Lead/Header System. The study is designed to collect product performance information, any reportable adverse events and withdrawal data.

The primary purpose of this study is to evaluate, document and report on the appropriate clinical performance, the long-term reliability and the functional integrity of the 4-SITE Lead/Header System. This 4-SITE Lead/Header System consists of a 4-SITE ENDOTAK® RELIANCE defibrillation lead connected to a 4-SITE Header (which is the only PG component under study) of a single or dual chamber (VR and DR) implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy ICD (CRT-D) BSC pulse generator. Additionally, system-related diagnostic information and implant data will be collected during the conduct of this study.

Study Design

• Study Type: Observational
• Actual Enrollment: 1820 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Longitudinal Surveillance Study of the 4-SITE Lead/Header System
• Actual Study Start Date: Apr 4, 2013
• Actual Primary Completion Date: Feb 18, 2020
• Actual Study Completion Date: Feb 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Medically Indicated for ICD or CRT-D Medically Indicated for ICD or CRT-D implantation per guidelines

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years [5 years]

   The 4-SITE Lead/Header System will be evaluated based on the "chronic 4-SITE Lead/Header System-related complication-free rate" for the five (5) year follow-up period after the index implantation. The primary endpoint analysis will include confirmed chronic 4-SITE Lead/Header System-related complications that result in study subject permanent loss of therapy, invasive intervention, injury or death.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• medically indicated for ICD/CRT-D

• received/plan to receive study lead

• willing for long-term follow-up

Exclusion Criteria:

• unwilling to comply with protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Alaska Medical Center	Anchorage	Alaska	United States	99508
2	Cardiovascular Consultants, LTD	Glendale	Arizona	United States	85032
3	Cardiovascular Associates of Mesa	Mesa	Arizona	United States	85206
4	Phoenix Cardiovascular Research Group	Phoenix	Arizona	United States	85006
5	Heart Clinic Arkansas	Little Rock	Arkansas	United States	72205
6	Providence St. Joseph Medical Center	Burbank	California	United States	91505
7	Palomar Medical Center	Escondido	California	United States	92025
8	California Heart Associates	Fountain Valley	California	United States	92708
9	Luc Sinh Nguyen, MD, FACC, Inc.	Fountain Valley	California	United States	92708
10	Providence Holy Cross Medical Center	Los Angeles	California	United States	90024
11	Cardiac Device Rhythm Specialists	Los Angeles	California	United States	90033
12	Comprehensive Cardiovascular Medical Group	Los Angeles	California	United States	93309
13	Desert Regional Medical Center	Palm Springs	California	United States	62262
14	Truong D. Duong, MD. A Medical Corporation	Riverside	California	United States	92503
15	San Diego Arrhythmia Associates	San Diego	California	United States	92103
16	Good Samaritan Hospital - San Jose	San Jose	California	United States	95124
17	Santa Barbara Cottage Hospital	Santa Barbara	California	United States	93102
18	Little Company of Mary Hospital	Torrance	California	United States	90503
19	University of Colorado Hospital	Aurora	Colorado	United States	80045
20	South Denver Cardiology Associates, PC	Denver	Colorado	United States	80120
21	Danbury Hospital	Danbury	Connecticut	United States	06810
22	Yale University School of Medicine	New Haven	Connecticut	United States	06520
23	Bradenton Cardiology	Bradenton	Florida	United States	34205
24	Clearwater Cardiovascular Consultants	Clearwater	Florida	United States	33756
25	Broward General Medical Center	Fort Lauderdale	Florida	United States	33316
26	North Florida Regional Medical Center	Gainesville	Florida	United States	32605
27	First Coast Cardiovascular	Jacksonville	Florida	United States	32216
28	Baptist Medical Center	Jacksonville	Florida	United States	32250
29	Osceola Regional Medical Center	Kissimmee	Florida	United States	34741
30	Cardiovascular Research Center of South Florida	Miami	Florida	United States	33173
31	Charlotte Heart & Vascular	Port Charlotte	Florida	United States	33952
32	Brevard Cardiovascular Research Associates, Inc.	Rockledge	Florida	United States	32955
33	Tallahassee Memorial Hospital	Tallahassee	Florida	United States	32308
34	Tampa General Hospital	Tampa	Florida	United States	33606
35	Phoebe Putney Memorial Hospital	Albany	Georgia	United States	31701
36	Northeast Georgia Heart Center	Gainesville	Georgia	United States	30501
37	Gwinnett Hospital System Inc.	Lawrenceville	Georgia	United States	30046
38	Georgia Arrhythmia Consultants	Macon	Georgia	United States	31201
39	Atlanta Heart Associates	Stockbridge	Georgia	United States	30281
40	University of Chicago Hospital	Chicago	Illinois	United States	60637
41	Illinois Heart and Vascular at Adventist Hinsdale Hospital	Hinsdale	Illinois	United States	60521
42	Heartland Cardiovascular Center	Joliet	Illinois	United States	60435
43	Carle Foundation Hospital	Urbana	Illinois	United States	61801
44	Bloomington Hospital	Bloomington	Indiana	United States	47403
45	Parkview Memorial Hospital	Fort Wayne	Indiana	United States	46805
46	Mercy Hospital Medical Center	Des Moines	Iowa	United States	50314
47	The Iowa Clinic, PC	Des Moines	Iowa	United States	50314
48	Kansas City Heart Foundation	Kansas City	Kansas	United States	64114
49	Via-Christi Regional Medical Center	Wichita	Kansas	United States	67214
50	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
51	University of Maryland Medical System	Baltimore	Maryland	United States	21201
52	MedStar Health Research Institute	Baltimore	Maryland	United States	21237
53	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
54	St. Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
55	Covenant Medical Center	Saginaw	Michigan	United States	48602
56	Munson Medical Center	Traverse City	Michigan	United States	49684
57	Centracare Heart and Vascular Center	Saint Cloud	Minnesota	United States	56303
58	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
59	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
60	St. Louis University Hospital	Saint Louis	Missouri	United States	63104
61	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
62	Cox Health	Springfield	Missouri	United States	65807
63	Billings Clinic	Billings	Montana	United States	59107
64	St. Patrick Hospital	Missoula	Montana	United States	59802
65	Nebraska Heart Institute	Lincoln	Nebraska	United States	68526
66	Deborah Heart and Lung Center	Browns Mills	New Jersey	United States	08015
67	Englewood Hospital and Medical Center	Englewood	New Jersey	United States	07631
68	Cardiovascular Associates of the Delaware Valley	Sewell	New Jersey	United States	08080
69	North Shore University Hospital	Manhasset	New York	United States	11030
70	Rochester General Hospital	Rochester	New York	United States	14621
71	SUNY-Stony Brook School of Medicine	Stony Brook	New York	United States	24421
72	Cardiology Group of West New York	Williamsville	New York	United States	14221
73	Universtity of Cincinnati	Cincinnati	Ohio	United States	45267
74	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
75	Kettering Medical Center	Kettering	Ohio	United States	45429
76	The Toledo Hospital	Toledo	Ohio	United States	43615
77	Genesis Healthcare System	Zanesville	Ohio	United States	43701
78	Salem Hospital	Salem	Oregon	United States	97302
79	The Arrhythmia Institute	Newton	Pennsylvania	United States	18940
80	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102
81	Cardiology Consultants of Philadelphia	Yardley	Pennsylvania	United States	19067
82	Southcoast Physicians Group	Providence	Rhode Island	United States	02904
83	Sisters of Charity Providence Hospital	Columbia	South Carolina	United States	29204
84	PeeDee Cardiology Associates PA	Florence	South Carolina	United States	29506
85	Piedmont Medical Center	Greenwood	South Carolina	United States	29646
86	Lexington Medical Center	Lexington	South Carolina	United States	29072
87	Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
88	Rapid City Regional Hospit	Rapid City	South Dakota	United States	57701
89	Saint Thomas Health	Nashville	Tennessee	United States	37205
90	Wellmont Holston Valley Medical Center	Rogersville	Tennessee	United States	37857
91	SouthEast Texas Clinical Research Center	Beaumont	Texas	United States	77702
92	Houston Arrhythmia Associates	Houston	Texas	United States	77024
93	Arrhythmia Associates of South Texas	San Antonio	Texas	United States	78217
94	Trinity Mother Frances Health System	Tyler	Texas	United States	75701
95	Intermountain Medical Center	Murray	Utah	United States	84107
96	University of Utah Hospital and Clinics	Salt Lake City	Utah	United States	84132
97	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
98	Virginia Commonwealth University Health System	Richmond	Virginia	United States	23219
99	Virginia Mason Medical Center	Seattle	Washington	United States	98101
100	Charleston Area Medical Center	Charleston	West Virginia	United States	25304
101	Monongalia General Hospital	Morgantown	West Virginia	United States	26505
102	Bellin Health	Green Bay	Wisconsin	United States	54305
103	Meriter Hospital, Inc.	Madison	Wisconsin	United States	53713
104	Cheyenne Regional Medical Center	Cheyenne	Wyoming	United States	82001
105	Mount Hospital	Perth	Western Australia	Australia	6000
106	Foothills Medical Centre	Calgary	Alberta	Canada
107	University of Alberta Hospital	Edmonton	Alberta	Canada
108	Royal Columbian Hospital	New Westminster	British Columbia	Canada	V3L 3W7
109	Hamilton General Hospital	Hamilton	Ontario	Canada	L8L 2X2
110	Fleurimont Hospital	Sherbrooke	Quebec	Canada	J1H5N4
111	Institut universitaire de Cardiologie et de Pneumologie de Quebec	Ste Foy	Quebec	Canada	G1V 4G5

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Stephen Kutalek, MD, Drexel University, USA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 2, 2012

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01596595
• Other Study ID Numbers: LSS of 4-SITE
• First Posted: May 11, 2012
• Last Update Posted: Mar 19, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Boston Scientific Corporation: ICD; CRT-D; Defibrillation lead
• Additional relevant MeSH terms: Heart Arrest; Death, Sudden, Cardiac

Study Results

Participant Flow

Arm/Group Title	RELIANCE 4-SITE
Arm/Group Description	There were 1820 patients who were consented for participation in the LSS of 4-SITE Study. Of the 1820 participants enrolled 1779 were implanted and followed for the study. There were 11 subjects who were attempted for implant but did not receive a study devices and 30 subjects who were determined to be intent subjects (did not undergo surgery) and were withdrawn from the study.
Period Title: Overall Study
STARTED	1779
COMPLETED	814
NOT COMPLETED	965

Baseline Characteristics

Arm/Group Title	RELIANCE 4-SITE
Arm/Group Description	Baseline characteristics include enrolled subjects who were implanted (1779) or attempted for implant (11) of an ENDOTAK® RELIANCE 4-SITE lead and Boston Scientific pulse generator compatible with the RELIANCE 4-SITE family of cardiac leads. Intent subjects (30) are not included in the baseline characteristics.
Overall Participants	1790
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.0 (12.0)
Sex: Female, Male (Count of Participants)
Female	481 26.9%
Male	1309 73.1%
Race/Ethnicity, Customized (Participant selections) [Number]
Caucasian	1345
Black	249
Hispanic	106
Not Disclosed	39
Asian	24
American Indian or Alaska Native	19
Hawaiian	2
Other	7
Missing data	8
Region of Enrollment (participants) [Number]
Canada	107 6%
United States	1681 93.9%
Australia	2 0.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years
Description	The 4-SITE Lead/Header System will be evaluated based on the "chronic 4-SITE Lead/Header System-related complication-free rate" for the five (5) year follow-up period after the index implantation. The primary endpoint analysis will include confirmed chronic 4-SITE Lead/Header System-related complications that result in study subject permanent loss of therapy, invasive intervention, injury or death.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RELIANCE 4-SITE
Arm/Group Description	There were 1820 patients who were consented for participation in the LSS of 4-SITE Study. Of the 1820 participants enrolled 1779 were implanted and followed for the study. There were 11 subjects who were attempted for implant but did not receive a study devices and 30 subjects who were determined to be intent subjects (did not undergo surgery) and were withdrawn from the study. These 41 subjects are not included in the endpoint analysis. The endpoint was analyzed using intent to treat analysis.
Measure Participants	1779
Number (95% Confidence Interval) [Percentage of participants]	98.9 5.5%

Adverse Events

Time Frame	Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.
Arm/Group Title	RELIANCE 4-SITE
Arm/Group Description	All-Cause Mortality and Adverse Events are reported for all enrolled subjects (N=1820).
All Cause Mortality
	RELIANCE 4-SITE
	Affected / at Risk (%)	# Events
Total	327/1820 (18%)
Serious Adverse Events
	RELIANCE 4-SITE
	Affected / at Risk (%)	# Events
Total	1017/1820 (55.9%)
Blood and lymphatic system disorders
Hematological	39/1820 (2.1%)
Cardiac disorders
3rd Degree AV Block	1/1820 (0.1%)
Sinus Bradycardia	5/1820 (0.3%)
Pulseless Electrical Activity (PEA)	13/1820 (0.7%)
Ventricular Fibrillation (VF)	29/1820 (1.6%)
Ventricular Tachycardia (VT)/Monomorphic VT	72/1820 (4%)
Torsades de Pointes	1/1820 (0.1%)
Nonsustained ventricular tachycardia (NSVT)	6/1820 (0.3%)
Atrial Fibrillation (AF)	83/1820 (4.6%)
Atrial Flutter	15/1820 (0.8%)
Sinus Tachycardia	1/1820 (0.1%)
Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)	10/1820 (0.5%)
Premature Ventricular Contractions (PVC)	2/1820 (0.1%)
Syncope - Heart Failure	1/1820 (0.1%)
Dizziness - Heart Failure	1/1820 (0.1%)
Chest Pain - Heart Failure	7/1820 (0.4%)
Dyspnea - Heart Failure	108/1820 (5.9%)
Peripheral edema - Heart Failure	10/1820 (0.5%)
Pulmonary Edema - Heart Failure	15/1820 (0.8%)
Fatigue - Heart Failure	1/1820 (0.1%)
Renal Failure/Insufficiency - Heart Failure	12/1820 (0.7%)
Dehydration - Heart Failure	2/1820 (0.1%)
Gastrointestinal - Heart Failure	4/1820 (0.2%)
Hypotension - Heart Failure	4/1820 (0.2%)
Weight Gain - Heart Failure	16/1820 (0.9%)
Heart Failure Symptoms - Unspecified	142/1820 (7.8%)
Multiple Heart Failure Symptoms	185/1820 (10.2%)
Hypertension - Heart Failure	2/1820 (0.1%)
Heart Failure Patient Condition - Cardiovascular - OTHER	6/1820 (0.3%)
Multi-system Failure - Heart Failure	13/1820 (0.7%)
Cardiogenic Shock	20/1820 (1.1%)
Cardiac Arrest	41/1820 (2.3%)
Aortic Stenosis	9/1820 (0.5%)
Aortic Regurgitation	1/1820 (0.1%)
Mitral Stenosis	1/1820 (0.1%)
Mitral Regurgitation	9/1820 (0.5%)
Palpitations	1/1820 (0.1%)
Patient Condition - Cardiovascular - OTHER	62/1820 (3.4%)
Pericardial effusion - unrelated procedure/device	3/1820 (0.2%)
Pericarditis - unrelated procedure/device	4/1820 (0.2%)
Endocrine disorders
Endocrine	27/1820 (1.5%)
Gastrointestinal disorders
Gastrointestinal	188/1820 (10.3%)
General disorders
Syncope	37/1820 (2%)
Dizziness	23/1820 (1.3%)
Chest Pain - Other	68/1820 (3.7%)
Fatigue/Weakness	2/1820 (0.1%)
Multiple Symptoms	5/1820 (0.3%)
Patient Condition - Non-Cardiovascular - OTHER	47/1820 (2.6%)
Death	38/1820 (2.1%)
Physical Trauma	76/1820 (4.2%)
Abnormal Laboratory Values	36/1820 (2%)
Head, eyes, ears, nose, throat (HEENT)	37/1820 (2%)
Multi-System Failure	8/1820 (0.4%)
Infections and infestations
Infection (> 30 days post implant)	8/1820 (0.4%)
System Infection	76/1820 (4.2%)
Fever and/or Virus	6/1820 (0.3%)
Injury, poisoning and procedural complications
Hematoma- Pocket (>30 days post implant)	1/1820 (0.1%)
Migration	1/1820 (0.1%)
Post Surgical wound discomfort/bruising/swelling	3/1820 (0.2%)
Post-surgical pocket hemorrhage/bleeding/drainage	1/1820 (0.1%)
Post -Surgical infection (≤ 30 days post implant)	3/1820 (0.2%)
Adverse Reaction - Respiratory	2/1820 (0.1%)
Chest pain	5/1820 (0.3%)
Hematoma - pocket (≤ 30 days post-implant)	8/1820 (0.4%)
Thromboembolic events	4/1820 (0.2%)
Procedure - PG System - Other	1/1820 (0.1%)
Pneumothorax	6/1820 (0.3%)
Hemothorax	2/1820 (0.1%)
Myocardial perforation without tamponade	1/1820 (0.1%)
Myocardial perforation with tamponade	1/1820 (0.1%)
Pericardial Effusion	3/1820 (0.2%)
Procedure - Lead - Other	1/1820 (0.1%)
Musculoskeletal and connective tissue disorders
Musculoskeletal	83/1820 (4.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	68/1820 (3.7%)
Nervous system disorders
Neurological	54/1820 (3%)
Product Issues
Other - PG System	2/1820 (0.1%)
Elevated Threshold - RV	1/1820 (0.1%)
Inappropriate Tachy Therapy - SVT	30/1820 (1.6%)
Inappropriate Tachy Therapy - Other	6/1820 (0.3%)
Early ERI - Premature Declaration	1/1820 (0.1%)
Pacemaker Mediated Tachycardia (PMT)	2/1820 (0.1%)
Erosion	2/1820 (0.1%)
Dislodgement - Unable to Capture - RA	1/1820 (0.1%)
Dislodgement - Multiple signs- RA	1/1820 (0.1%)
Dislodgement - No reported signs - RA	4/1820 (0.2%)
Other Lead Related	3/1820 (0.2%)
Oversensing - RV	1/1820 (0.1%)
Unable to Capture - RV	3/1820 (0.2%)
Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV	3/1820 (0.2%)
Extracardiac Stimulation - RV	1/1820 (0.1%)
Insulation Breach - RV	2/1820 (0.1%)
Myocardial Perforation post implant- RV	3/1820 (0.2%)
Low Out of Range Impedance - RV	1/1820 (0.1%)
Dislodgement - Unable to capture - RV	3/1820 (0.2%)
Dislodgement - Elevated threshold - RV	4/1820 (0.2%)
Dislodgement - Extracardiac stimulation - RV	1/1820 (0.1%)
Dislodgement - Multiple signs - RV	1/1820 (0.1%)
Dislodgement - No reported signs - RV	4/1820 (0.2%)
Unable to Capture - LV	1/1820 (0.1%)
Extracardiac Stimulation - LV	3/1820 (0.2%)
Conductor Coil Fracture - LV	1/1820 (0.1%)
Insulation Breach - LV	1/1820 (0.1%)
Dislodgement - Unable to Capture - LV	4/1820 (0.2%)
Dislodgement - Elevated threshold - LV	1/1820 (0.1%)
Dislodgement - Extracardiac stimulation - LV	1/1820 (0.1%)
Dislodgement - Multiple signs - LV	1/1820 (0.1%)
Dislodgement - No reported signs - LV	7/1820 (0.4%)
Inappropriate tachy therapy - SVT	2/1820 (0.1%)
Psychiatric disorders
Psychological	8/1820 (0.4%)
Renal and urinary disorders
Genitourinary	50/1820 (2.7%)
Renal	108/1820 (5.9%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	12/1820 (0.7%)
Pulmonary	183/1820 (10.1%)
Skin and subcutaneous tissue disorders
Integumentary	39/1820 (2.1%)
Vascular disorders
Hypotension/Orthostatic Hypotension	37/1820 (2%)
Hypertension/Hypertensive Crisis	11/1820 (0.6%)
Myocardial Infarction	62/1820 (3.4%)
Peripheral Vascular Disease	38/1820 (2.1%)
Intermittent Claudication	2/1820 (0.1%)
Chest Pain - Ischemic	19/1820 (1%)
Transient Ischemic Attack (TIA)	25/1820 (1.4%)
Cerebrovascular Accident (CVA)	51/1820 (2.8%)
Deep Vein Thrombosis (DVT)	12/1820 (0.7%)
Pulmonary Embolism (PE)	16/1820 (0.9%)
Distal thromboemboli	1/1820 (0.1%)
Hematoma - unrelated procedure/device	3/1820 (0.2%)
Hemorrhage - unrelated procedure/device	1/1820 (0.1%)
Other (Not Including Serious) Adverse Events
	RELIANCE 4-SITE
	Affected / at Risk (%)	# Events
Total	980/1820 (53.8%)
Blood and lymphatic system disorders
Hematological	34/1820 (1.9%)
Cardiac disorders
Sinus Bradycardia	2/1820 (0.1%)
Chronotropic Incompetence	1/1820 (0.1%)
Ventricular Fibrillation (VF)	24/1820 (1.3%)
Ventricular Tachycardia (VT)/Monomorphic VT	73/1820 (4%)
Torsades de Pointes	1/1820 (0.1%)
Nonsustained ventricular tachycardia (NSVT)	54/1820 (3%)
Atrial Fibrillation (AF)	111/1820 (6.1%)
Atrial Flutter	28/1820 (1.5%)
Sinus Tachycardia	4/1820 (0.2%)
Atrial Tachycardia/Other SVT (e.g. AVRT, AVNRT, EAT)	25/1820 (1.4%)
Premature Ventricular Contractions (PVC)	17/1820 (0.9%)
Syncope - Heart Failure	1/1820 (0.1%)
Dizziness - Heart Failure	1/1820 (0.1%)
Chest Pain - Heart Failure	4/1820 (0.2%)
Dyspnea - Heart Failure	49/1820 (2.7%)
Peripheral edema - Heart Failure	39/1820 (2.1%)
Pulmonary Edema - Heart Failure	4/1820 (0.2%)
Fatigue - Heart Failure	4/1820 (0.2%)
Renal Failure/Insufficiency - Heart Failure	1/1820 (0.1%)
Gastrointestinal - Heart Failure	1/1820 (0.1%)
Hypotension - Heart Failure	1/1820 (0.1%)
Weight Gain - Heart Failure	6/1820 (0.3%)
Heart Failure Symptoms - Unspecified	37/1820 (2%)
Multiple Heart Failure Symptoms	75/1820 (4.1%)
Hypertension - Heart Failure	1/1820 (0.1%)
Heart Failure Patient Condition - Cardiovascular - OTHER	3/1820 (0.2%)
Aortic Stenosis	1/1820 (0.1%)
Aortic Regurgitation	2/1820 (0.1%)
Mitral Regurgitation	6/1820 (0.3%)
Palpitations	16/1820 (0.9%)
Patient Condition - Cardiovascular - OTHER	32/1820 (1.8%)
Intracardiac thrombus	8/1820 (0.4%)
Pericardial effusion - unrelated procedure/device	1/1820 (0.1%)
Pericarditis - unrelated procedure/device	2/1820 (0.1%)
Endocrine disorders
Endocrine	58/1820 (3.2%)
Gastrointestinal disorders
Gastrointestinal	166/1820 (9.1%)
General disorders
Syncope	23/1820 (1.3%)
Dizziness	65/1820 (3.6%)
Chest Pain - Other	83/1820 (4.6%)
Fatigue/Weakness	39/1820 (2.1%)
Patient Condition - Non-Cardiovascular - OTHER	109/1820 (6%)
Physical Trauma	97/1820 (5.3%)
Abnormal Laboratory Values	95/1820 (5.2%)
Head, eyes, ears, nose, throat (HEENT)	185/1820 (10.2%)
Immune system disorders
Immune	7/1820 (0.4%)
Infections and infestations
Infection (> 30 days post implant)	3/1820 (0.2%)
System Infection	7/1820 (0.4%)
Fever and/or Virus	1/1820 (0.1%)
Injury, poisoning and procedural complications
Hematoma- Pocket (>30 days post implant)	1/1820 (0.1%)
Seroma - Pocket (>30 days post implant)	1/1820 (0.1%)
Migration	3/1820 (0.2%)
Post Surgical wound discomfort/bruising/swelling	82/1820 (4.5%)
Post-surgical pocket hemorrhage/bleeding/drainage	4/1820 (0.2%)
Post -Surgical infection (≤ 30 days post implant)	6/1820 (0.3%)
Adverse Reaction - General	10/1820 (0.5%)
Adverse Reaction - Respiratory	2/1820 (0.1%)
Adverse Reaction - Bradycardia	1/1820 (0.1%)
Adverse Reaction - Hypotension	3/1820 (0.2%)
Inadvertent VT/VF	1/1820 (0.1%)
Chest pain	6/1820 (0.3%)
Physical trauma	5/1820 (0.3%)
Hematoma - pocket (≤ 30 days post-implant)	72/1820 (4%)
Seroma - Pocket (≤ 30 days post implant)	2/1820 (0.1%)
Thromboembolic events	9/1820 (0.5%)
Procedure - PG System - Other	9/1820 (0.5%)
Puncture Site hematoma	1/1820 (0.1%)
Pneumothorax	2/1820 (0.1%)
Pleural effusion	1/1820 (0.1%)
Musculoskeletal and connective tissue disorders
Musculoskeletal	165/1820 (9.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	34/1820 (1.9%)
Nervous system disorders
Neurological	67/1820 (3.7%)
Product Issues
Oversensing - RA	8/1820 (0.4%)
Unable to Capture - RA	1/1820 (0.1%)
Other - PG System	1/1820 (0.1%)
Oversensing - RV 1120 - Undersensing - RV	2/1820 (0.1%)
Elevated Threshold - RV	4/1820 (0.2%)
Elevated Threshold - LV	3/1820 (0.2%)
Extracardiac Stimulation - LV	7/1820 (0.4%)
Inappropriate Tachy Therapy - SVT	43/1820 (2.4%)
Inappropriate Tachy Therapy - Other	11/1820 (0.6%)
Early ERI - Premature declaration	1/1820 (0.1%)
Pacemaker Mediated Tachycardia (PMT)	6/1820 (0.3%)
Oversensing - RA	3/1820 (0.2%)
Undersensing - RA 2032 - Unable to Capture - RA	1/1820 (0.1%)
Elevated Threshold - RA	2/1820 (0.1%)
Extracardiac Stimulation - RA	2/1820 (0.1%)
Conductor Coil Fracture - RA	1/1820 (0.1%)
High Out of Range Impedance - RA	1/1820 (0.1%)
Dislodgement - Multiple signs- RA	1/1820 (0.1%)
Dislodgement - No reported signs - RA	4/1820 (0.2%)
Other Lead Related	7/1820 (0.4%)
Oversensing - RV	7/1820 (0.4%)
Undersensing - RV	2/1820 (0.1%)
Unable to Capture - RV	1/1820 (0.1%)
Elevated Threshold - RV 2140 - Extracardiac Stimulation - RV	12/1820 (0.7%)
Extracardiac Stimulation - RV	4/1820 (0.2%)
Myocardial Perforation post implant- RV	2/1820 (0.1%)
Low Out of Range Impedance - RV	2/1820 (0.1%)
Dislodgement - Unable to capture - RV	3/1820 (0.2%)
Dislodgement - Elevated threshold - RV	3/1820 (0.2%)
Dislodgement - Oversensing- RV	1/1820 (0.1%)
Dislodgement - Multiple signs - RV	2/1820 (0.1%)
Dislodgement - No reported signs - RV	3/1820 (0.2%)
Unable to Capture - LV	3/1820 (0.2%)
Elevated Threshold - LV	8/1820 (0.4%)
Extracardiac Stimulation - LV	29/1820 (1.6%)
Low Out of Range Impedance - LV	1/1820 (0.1%)
Dislodgement - Unable to Capture - LV	1/1820 (0.1%)
Dislodgement - No reported signs - LV	1/1820 (0.1%)
Unable to Convert	1/1820 (0.1%)
Inappropriate tachy therapy - SVT	1/1820 (0.1%)
Inappropriate tachy therapy - Noise	1/1820 (0.1%)
Psychiatric disorders
Psychological effect due to device therapy	3/1820 (0.2%)
Psychological	29/1820 (1.6%)
Renal and urinary disorders
Genitourinary	95/1820 (5.2%)
Renal	74/1820 (4.1%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	41/1820 (2.3%)
Pulmonary	123/1820 (6.8%)
Skin and subcutaneous tissue disorders
Integumentary	99/1820 (5.4%)
Vascular disorders
Hypotension/Orthostatic Hypotension	65/1820 (3.6%)
Hypertension/Hypertensive Crisis	42/1820 (2.3%)
Myocardial Infarction	7/1820 (0.4%)
Peripheral Vascular Disease	27/1820 (1.5%)
Intermittent Claudication	2/1820 (0.1%)
Chest Pain - Ischemic	14/1820 (0.8%)
Transient Ischemic Attack (TIA)	5/1820 (0.3%)
Cerebrovascular Accident (CVA)	3/1820 (0.2%)
Deep Vein Thrombosis (DVT)	12/1820 (0.7%)
Pulmonary Embolism (PE)	1/1820 (0.1%)
Distal thromboemboli	2/1820 (0.1%)
Hematoma - unrelated procedure/device	6/1820 (0.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.