RallyX4: Maximizing CRT Delivery by Using MultipolAr Coronary Sinus Lead FamiLy ACUITY® X4 - RALLY X4 Study

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02066467
• Collaborator: ICON plc (Industry)
• Enrollment: 863
• Locations: 83
• Actual Duration (Months): 31
• Patients Per Site: 10.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting.

It is a prospective, non-randomized, observational multicenter study evaluating standard of care.

For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse events and basic parameters of the lead will be assessed. The cohort of subjects included in this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to receive an ACUITY X4® lead implant.

Study endpoints:

Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant.

Condition or Disease	Intervention/Treatment	Phase
Heartfailure	Device: Left Ventricular lead implant: ACUITY X4® Lead Family

Detailed Description

Clinic visits will occur at:

• Enrollment and Consenting Clinic Visit (≤ 30 days prior to implant procedure)

• Implant Procedure (Day 0; all future follow ups based on this date)

• Pre-Discharge Clinic Visit (≤ 7 days post implant procedure) (Required)

• One to 6 Month Clinic Visit (20 to 180 days post implant procedure) (Required)

• Interim Visit(s) (Any time between the 1 to 6 Month Clinic Visit and Close-out Clinic Visit) (Following study center specific standard of care) (Device follow up optional) AE

• reporting required

• Close-out Clinic Visit (30 months ± 90 days, OR 180 days ± 90 days after the study is closed to enrollment, whichever comes first) (Required)

• During the trial all AEs, deaths, and changes in the device system must be reported

• Devices of subjects who have received a Latitude device will be followed by the Boston Scientific (BSC) Latitude team. Device Data as defined in the Clinical Investigation Plan (CIP), device alerts, and diagnostic data from the standard Latitude database may be collected and entered into the study database at any time.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 863 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY® X4
• Actual Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Heart failure patients Subjects with art failure who receive stable optimal pharmacologic therapy Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' .

Device: Left Ventricular lead implant: ACUITY X4® Lead Family; Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment; Other Names: Autogen™X4 CRT-D G179-200 G177-200 Dynagen™ X4 CRT-D G158-200 G156-200 Inogen™ X4 CRT-D G148-200 G146-200 Origen™ X4 CRT-D G058-200 G056-200

Outcome Measures

Primary Outcome Measures

1. Phrenic Nerve Complication Free Rate [6 months post-implant]

   The Phrenic Nerve Stimulation (PNS) related Complication Free rate (CFR) through 6 months post-implant is defined as the rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold

Secondary Outcome Measures

1. 3 Month Lead-related Complication-Free Rate (CFR) [3 months post-implant]

   Lead-related Complication-Free Rate (CFR) from implant through 3 months post-implant. Lead-related complications associated with the ACUITY X4® lead were counted towards this endpoint.

Other Outcome Measures

1. 3 Month Implant Success Rate for Indicated Subjects [3 months post-implant]

   Post Market Clinical Follow-up (PMCF) of the ACUITY X4® lead was evaluated in this study. The outcome of interest is the 3 month implant success rate. The cohort of subjects included in this evaluation is the first 200 subjects to receive an ACUITY X4® lead implant and meet the PMCF eligibility criteria outlined below. The outcomes of interest for the PMCF supplemental analysis is the percent of subjects successfully implanted with an ACUITY X4® lead. Implant success is defined as the ability of the ACUITY X4® lead to be implanted and deliver CRT therapy. Subjects who have multiple lead implant attempts during the procedure, but are eventually successfully implanted with the ACUITY X4® lead and receive CRT therapy are classified as a successful implant.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Subject is willing and capable of providing informed consent

2. Subject is planned to be implanted with an ACUITY X4® lead for left-ventricular pacing and sensing via the coronary venous system in conjunction with a compatible BSC pulse generator

3. Subject is willing and capable of participating in all visits associated with this study at an approved clinical study center and at the intervals defined by this CIP

4. Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

1. Subjects with a hypersensitivity to a maximum single dose of 0.51 mg dexamethasone acetate

2. Subject is enrolled in any other concurrent study without prior written approval from BSC, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:

• Schedule of procedures for the RALLY X4 Study (i.e. should not cause additional or missed visits);

• RALLY X4 Study outcome (i.e. involve medications that could affect the heart rate of the subject);

• Conduct of the RALLY X4 Study per GCP/ ISO 14155:2011/ local regulations as applicable

1. Per the implanting physician's discretion, the subject is not a suitable candidate to receive the study device as determined during the implant procedure

2. Women of childbearing potential who are or might be pregnant at the time of study enrollment or ACUITY X4® lead implant.

3. Subject is unwilling or unable to participate in all scheduled study follow up visits at an approved study center

4. Subject does not anticipate being a resident of the area for the scheduled duration of the trial

5. Subject's physician does not allow participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Landesklinikum St.Pölten	St.Pölten		Austria
2	Cliniques Universitaires Saint-Luc	Brussels		Belgium
3	Guidant Europe SA / NV a Boston Scientific Company	Diegem		Belgium	1831
4	Universitair Ziekenhuis Gent	Gent		Belgium
5	Fundation Cardioinfantil	Bogota		Colombia
6	Fundación Valle del Lili	Cali		Colombia
7	Clinica Medellin	Medellin		Colombia
8	Gentofte Hospital	Copenhagen		Denmark
9	Aarhus University Hospital	Skejby		Denmark
10	Helsinki University Central Hospital	Helsinki		Finland
11	Oulu University Hospital	Oulu		Finland
12	CHU Amiens	Amiens		France
13	Centre Hospitalier d'Annecy	Annecy		France
14	CHU de Clermont-Ferrand	Clermont-Ferrand		France
15	CHU de Grenoble	Grenoble		France
16	Centre Hospitalier Régional Universitaire de Lille	Lille		France
17	Hôpital de la Timone	Marseille		France
18	Nouvelles Cliniques Nantaises	Nantes		France
19	Centre Hospitalier de Pau	Pau		France
20	CHU de Rennes	Rennes		France
21	CH de Rouen	Rouen		France
22	Clinique Pasteur	Toulouse		France
23	Herzzentrum Nordrhein-Westfalen	Bad Oeynhausen		Germany
24	Deutsches Herzzentrum Berlin	Berlin		Germany
25	Unfallkrankenhaus Berlin	Berlin		Germany
26	Waldklinikum Gera	Gera		Germany
27	Herz-und Gefäßzentrum Göttingen	Göttingen		Germany
28	Klinikum Kassel	Kassel		Germany
29	Krankenhaus Landshut-Achdorf	Landshut		Germany
30	University Magdeburg	Magdeburg		Germany
31	Klinikum Oldenburg	Oldenburg		Germany
32	Prince of Wales Hospital	Hong Kong		Hong Kong
33	Queen Mary Hospital	Hong Kong		Hong Kong
34	Waterfort Hospital	Waterford		Ireland
35	Barzilai Medical Center	Ashkelon		Israel
36	Beilinson Medical Center	Petah Tikva		Israel
37	Sheba Medical Center	Ramat Gan		Israel
38	Kaplan Medical Center	Rechovot		Israel
39	Tel Aviv Medical Center	Tel Aviv		Israel
40	Policlinico Sant'Orsola-Malpighi	Bologna		Italy
41	Azienda Ospedaliera Spedali Civili di Brescia	Brescia		Italy
42	Policlinico Vittorio Emanuele	Catania		Italy
43	Ospedale Pugliese Ciaccio	Catanzaro		Italy
44	Azienda Ospedaliera Spedale Sant'Anna di Como	Como		Italy
45	Clinica Montevergine	Mercogliano		Italy
46	Ospedale Santa Maria Misericordia	Rovigo		Italy
47	Ospedale Borgo Trento	Verona		Italy
48	Kansai Rosai Hospital	Amagasaki-Shi		Japan
49	Tokai University Hospital	Isehara-Shi		Japan
50	Shonan Kamakura General Hospital	Kamakura-Shi		Japan
51	Kokura Memorial Hospital	Kitakyushu-Shi		Japan
52	Kyorin University Hospital	Mitaka-Shi		Japan
53	Osaka General Medical Center	Osaka-Shi		Japan
54	Osaka Police Hospital	Osaka-Shi		Japan
55	Sakurabashi Watanabe Hospital	Osaka-Shi		Japan
56	Osaka Rosai Hospital	Sakai-Shi		Japan
57	Osaka University Hospital	Suita-Shi		Japan
58	Yokohama City University Hospital	Yokohama-Shi		Japan
59	Medisch Centrum Alkmaar	Alkmaar		Netherlands
60	Hospital Rijnstate	Arnheim		Netherlands
61	Medisch Spectrum Twente	Enschede		Netherlands
62	Isala	Zwolle		Netherlands
63	Centro Hospitalar de Vila Nova de Gaia	Gaia		Portugal
64	Centro Hospitalar do Alto Ave	Guimaraes		Portugal
65	Hospital Santa Cruz	Lisbon		Portugal
66	Hospital Santa Maria	Lisbon		Portugal
67	Centro Hospitalar do Porto	Porto		Portugal
68	Changi General Hospital	Singapore		Singapore
69	National Heart Centre	Singapore		Singapore
70	Hospital Clinic de Barcelona	Barcelona		Spain
71	Hospital Sant Pau	Barcelona		Spain
72	Doce De Octubre University Hospital	Madrid		Spain
73	Hospital Universitario Puerta de Hierro	Madrid		Spain
74	Clínica Universidad de Navarra	Pamplona		Spain
75	Hospital Vírgen de la Salud	Toledo		Spain
76	Hospital Clinico Valladolid	Valladolid		Spain
77	Hôpital Cantonal de Genève	Geneva		Switzerland
78	Centre Hospitalier Universitaire Vaudois	Lausanne		Switzerland
79	Institution Kantonsspital St. Gallen	St. Gallen		Switzerland
80	Queen Elisabeth Hospital	Birmingham		United Kingdom
81	Golden Jubilee National Hospital	Glasgow		United Kingdom
82	Imperial College Healthcare	London		United Kingdom
83	St Bartholomew's Hospital	London		United Kingdom

Sponsors and Collaborators

• Boston Scientific Corporation
• ICON plc

Investigators

• Principal Investigator: Haran Burri, Prof., Hôpital Cantonal de Genève
• Study Chair: Torsten Kayser, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02066467
• Other Study ID Numbers: Rally X4-10-2013
• First Posted: Feb 19, 2014
• Last Update Posted: Sep 20, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Boston Scientific Corporation: Phrenic Nerve Stimulation; Heartfailure treatment; CRT-D therapy; Quadripolar lead; Lead related complication free rate
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Recruitment Details	The first subject was enrolled on 10 February 2014. The clinical phase of the study was completed on 30 September 2016 which was the date of the last subject's close-out visit. A total of 863 subjects across 82 centers were enrolled in the study in Europe, Asia and South America.

Arm/Group Title	Heart Failure Patients
Arm/Group Description	Subjects with heart failure who receive stable optimal pharmacologic therapy Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
Period Title: Overall Study
STARTED	863
COMPLETED	648
NOT COMPLETED	215

Baseline Characteristics

Arm/Group Title	Heart Failure Patients
Arm/Group Description	Subjects with heart failure who receive stable optimal pharmacologic therapy Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
Overall Participants	863
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.5 (10.09)
Sex: Female, Male (Count of Participants)
Female	189 21.9%
Male	674 78.1%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Colombia	13 1.5%
Singapore	18 2.1%
Hong Kong	9 1%
Japan	60 7%
United Kingdom	38 4.4%
Switzerland	31 3.6%
Portugal	33 3.8%
Spain	67 7.8%
Austria	15 1.7%
Netherlands	57 6.6%
Belgium	5 0.6%
Ireland	12 1.4%
Finland	23 2.7%
Denmark	30 3.5%
Italy	124 14.4%
Israel	47 5.4%
France	119 13.8%
Germany	162 18.8%

Outcome Measures

1. Primary Outcome

Title	Phrenic Nerve Complication Free Rate
Description	The Phrenic Nerve Stimulation (PNS) related Complication Free rate (CFR) through 6 months post-implant is defined as the rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold
Time Frame	6 months post-implant

Outcome Measure Data

Analysis Population Description

795 patients successfully implanted with ACUITY X4 lead

Arm/Group Title	Heart Failure Patients
Arm/Group Description	Subjects with heart failure who receive stable optimal pharmacologic therapy Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
Measure Participants	795
Number (90% Confidence Interval) [% of participants]	99.5 11.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Heart Failure Patients
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	exact binominal methodology
	Comments

2. Secondary Outcome

Title	3 Month Lead-related Complication-Free Rate (CFR)
Description	Lead-related Complication-Free Rate (CFR) from implant through 3 months post-implant. Lead-related complications associated with the ACUITY X4® lead were counted towards this endpoint.
Time Frame	3 months post-implant

Outcome Measure Data

Analysis Population Description

795 patients successfully implanted with ACUITY X4 lead

Arm/Group Title	Heart Failure Patients
Arm/Group Description	Subjects with heart failure who receive stable optimal pharmacologic therapy Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
Measure Participants	795
Number (90% Confidence Interval) [% of participants]	98.8 11.4%

3. Other Pre-specified Outcome

Title	3 Month Implant Success Rate for Indicated Subjects
Description	Post Market Clinical Follow-up (PMCF) of the ACUITY X4® lead was evaluated in this study. The outcome of interest is the 3 month implant success rate. The cohort of subjects included in this evaluation is the first 200 subjects to receive an ACUITY X4® lead implant and meet the PMCF eligibility criteria outlined below. The outcomes of interest for the PMCF supplemental analysis is the percent of subjects successfully implanted with an ACUITY X4® lead. Implant success is defined as the ability of the ACUITY X4® lead to be implanted and deliver CRT therapy. Subjects who have multiple lead implant attempts during the procedure, but are eventually successfully implanted with the ACUITY X4® lead and receive CRT therapy are classified as a successful implant.
Time Frame	3 months post-implant

Outcome Measure Data

Analysis Population Description

At data cutoff date on 16 November 2015, 201 enrolled subjects met all of the PMCF eligibility criteria and were included in the analysis.

Arm/Group Title	Heart Failure Patients
Arm/Group Description	Subjects with heart failure who receive stable optimal pharmacologic therapy Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
Measure Participants	201
Number (90% Confidence Interval) [% of participants]	99.5 11.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Heart Failure Patients
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	exact binominal methodology
	Comments

Adverse Events

Time Frame	Adverse events are collected from 1st enrollment through study completion (last subject's close-out visit)
Adverse Event Reporting Description	All adverse events are collected as per ISO 14155:2011 and medical device guidance (MEDDEV) 2.7/3 12/2010 The number of participants at risk is defined as the subjects actively enrolled (838). Adverse events were not collected for subjects who did not undergo an implant procedure (24) and consent ineligible subjects (1).
Arm/Group Title	Heart Failure Patients
Arm/Group Description	Subjects with heart failure who receive stable optimal pharmacologic therapy Moderate to severe heart failure (NYHA Class III-IV) with ejection fraction (EF) ≤ 35% and QRS duration ≥ 120 ms Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure. The study is collecting observational data on regular CRT-D device implants with special focus on the left ventricular ACUITY X4® Lead Family' . Left Ventricular lead implant: ACUITY X4® Lead Family: Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
All Cause Mortality
	Heart Failure Patients
	Affected / at Risk (%)	# Events
Total	54/838 (6.4%)
Serious Adverse Events
	Heart Failure Patients
	Affected / at Risk (%)	# Events
Total	338/838 (40.3%)
Blood and lymphatic system disorders
Hematological	4/838 (0.5%)	5
Cardiac disorders
Aortic regurgitation	1/838 (0.1%)	1
Aortic stenosis	1/838 (0.1%)	1
Atrial fibrillation (AF)	41/838 (4.9%)	46
Atrial flutter	10/838 (1.2%)	11
Cardiac arrest	3/838 (0.4%)	3
Cardiogenic shock	4/838 (0.5%)	5
Cerebrovascular accident (CVA)	5/838 (0.6%)	5
Chest pain - Ischemic	5/838 (0.6%)	6
Chest pain - Other	6/838 (0.7%)	7
Coronary Artery Disease	6/838 (0.7%)	6
Distal thromboemboli	1/838 (0.1%)	1
Dizziness	1/838 (0.1%)	1
Dyspnea	3/838 (0.4%)	3
Dyspnea - Heart failure	9/838 (1.1%)	11
Fatigue	1/838 (0.1%)	1
Heart failure symptoms - Unspecified	49/838 (5.8%)	56
Hypertension	1/838 (0.1%)	1
Hypotension	1/838 (0.1%)	1
Mitral regurgitation	2/838 (0.2%)	2
Mitral stenosis	1/838 (0.1%)	1
Multiple heart failure symptoms	9/838 (1.1%)	10
Multi-system failure - Heart failure	5/838 (0.6%)	5
Myocardial infarction	3/838 (0.4%)	3
Nonsustained ventricular tachycardia (NSVT)	2/838 (0.2%)	2
Other- Heart failure patient condition - Cardiovascular	10/838 (1.2%)	12
Other SVT (eg AVRT, AVNRT, EAT)	5/838 (0.6%)	5
Palpitations	2/838 (0.2%)	2
Pericardial effusion	3/838 (0.4%)	3
Peripheral edema - Heart failure	1/838 (0.1%)	1
Peripheral vascular disease	6/838 (0.7%)	6
Premature ventricular contractions (PVC)	2/838 (0.2%)	2
Pulmonary edema - Heart failure	2/838 (0.2%)	3
Pulmonary embolism (PE)	2/838 (0.2%)	2
Renal insufficiency - Heart failure	1/838 (0.1%)	1
Sinus bradycardia	1/838 (0.1%)	1
Syncope	1/838 (0.1%)	1
Thromboembolic events	1/838 (0.1%)	1
Transient ischemic attack (TIA)	1/838 (0.1%)	1
Ventricular fibrillation (VF)	10/838 (1.2%)	15
Ventricular tachycardia (VT)	17/838 (2%)	27
Weight gain - Heart failure	1/838 (0.1%)	1
Endocrine disorders
Endocrine	3/838 (0.4%)	3
Gastrointestinal disorders
Gastrointestinal	20/838 (2.4%)	24
General disorders
Abnormal laboratory values	2/838 (0.2%)	2
Adverse reaction - Allergic reaction	1/838 (0.1%)	1
Adverse reaction - Hypotension	1/838 (0.1%)	1
Death	13/838 (1.6%)	13
Head, eyes, ears, nose, throat (HEENT)	10/838 (1.2%)	11
Intermittent Claudication	1/838 (0.1%)	1
Multi-system failure	3/838 (0.4%)	3
Other- Patient condition - Non- cardiovascular	4/838 (0.5%)	4
Physical trauma	5/838 (0.6%)	5
Immune system disorders
Immune	2/838 (0.2%)	2
Infections and infestations
Fever	2/838 (0.2%)	2
Systemic infection	3/838 (0.4%)	3
Musculoskeletal and connective tissue disorders
Musculoskeletal	9/838 (1.1%)	10
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	8/838 (1%)	9
Nervous system disorders
Neurological	3/838 (0.4%)	3
Product Issues
Device Deficiency	1/838 (0.1%)	1
Dislodgment - Elevated threshold - LV	1/838 (0.1%)	1
Dislodgment - Extracardiac stimulation- LV	2/838 (0.2%)	2
Dislodgment - Multiple signs - LV	1/838 (0.1%)	1
Dislodgment - No reported signs - RA	4/838 (0.5%)	4
Dislodgment - No reported signs - RV	3/838 (0.4%)	3
Dislodgment - No reported signs -LV	2/838 (0.2%)	2
Dislodgment - Unable to capture - LV	2/838 (0.2%)	2
Dislodgment - Unable to capture - RA	1/838 (0.1%)	1
Dislodgment - Unable to capture - RV	2/838 (0.2%)	2
Elevated threshold - LV	4/838 (0.5%)	4
Elevated threshold - RV	2/838 (0.2%)	2
Erosion	1/838 (0.1%)	1
Extracardiac stimulation - LV	4/838 (0.5%)	4
Extracardiac stimulation - RV	1/838 (0.1%)	1
Impedance > 2000 ohms - LV	1/838 (0.1%)	1
Inappropriate tachy therapy - Noise	1/838 (0.1%)	1
Inappropriate tachy therapy - Other	1/838 (0.1%)	1
Inappropriate tachy therapy - SVT	6/838 (0.7%)	6
Inappropriate tachy therapy- NSR	1/838 (0.1%)	1
Infection (> 30 days post-implant)	10/838 (1.2%)	10
Myocardial perforation post-implant - RA	1/838 (0.1%)	1
Myocardial perforation post-implant - RV	4/838 (0.5%)	4
Other - Lead	7/838 (0.8%)	7
Other - PG system	1/838 (0.1%)	1
Oversensing - RV	1/838 (0.1%)	1
Pacemaker-mediated tachycardia (PMT)	1/838 (0.1%)	1
Unable to capture - RA	1/838 (0.1%)	1
Psychiatric disorders
Psychological	1/838 (0.1%)	1
Renal and urinary disorders
Renal	12/838 (1.4%)	12
Reproductive system and breast disorders
Genitourinary	4/838 (0.5%)	5
Respiratory, thoracic and mediastinal disorders
COPD exacerbation	1/838 (0.1%)	2
Pulmonary	23/838 (2.7%)	28
Skin and subcutaneous tissue disorders
Integumentary	6/838 (0.7%)	8
Surgical and medical procedures
Coronary venous dissection	1/838 (0.1%)	1
Hematoma - Pocket (<= 30 days post-implant)	8/838 (1%)	8
Myocardial perforation with tamponade	1/838 (0.1%)	1
Myocardial perforation without tamponade	1/838 (0.1%)	1
Other - Lead - Procedure	9/838 (1.1%)	9
Other - PG system - Procedure	2/838 (0.2%)	2
Pleural effusion - Procedure	1/838 (0.1%)	1
Pneumothorax - Procedure	6/838 (0.7%)	6
Post-surgical infection (<= 30 days post-implant)	7/838 (0.8%)	8
Post-surgical pocket hemorrhage	2/838 (0.2%)	2
Post-surgical wound discomfort	1/838 (0.1%)	1
Venous occlusion	1/838 (0.1%)	1
Vascular disorders
Arterial/venous thrombolytic event	1/838 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Heart Failure Patients
	Affected / at Risk (%)	# Events
Total	452/838 (53.9%)
Blood and lymphatic system disorders
Hematological	2/838 (0.2%)	2
Cardiac disorders
Aortic regurgitation	1/838 (0.1%)	2
Atrial fibrillation (AF)	30/838 (3.6%)	33
Atrial flutter	2/838 (0.2%)	2
Chest pain - Heart failure	2/838 (0.2%)	2
Chest pain - Ischemic	2/838 (0.2%)	2
Chest pain - Other	5/838 (0.6%)	5
Dizziness	5/838 (0.6%)	5
Dyspnea	1/838 (0.1%)	1
Dyspnea - Heart failure	11/838 (1.3%)	13
Heart failure symptoms - Unspecified	2/838 (0.2%)	4
Hematoma - Unrelated to procedure or device	1/838 (0.1%)	1
Hypertension - Heart failure	1/838 (0.1%)	1
Hypotension	3/838 (0.4%)	3
Hypotension - Heart failure	1/838 (0.1%)	1
Multiple heart failure symptoms	2/838 (0.2%)	2
Multiple symptoms	1/838 (0.1%)	1
Nonsustained ventricular tachycardia (NSVT)	3/838 (0.4%)	3
Other- Heart failure patient condition - Cardiovascular	1/838 (0.1%)	1
Other SVT (eg AVRT, AVNRT, EAT)	3/838 (0.4%)	3
Palpitations	1/838 (0.1%)	1
Pericarditis - Unrelated to procedure or device	1/838 (0.1%)	1
Peripheral edema - Heart failure	3/838 (0.4%)	3
Premature ventricular contractions (PVC)	14/838 (1.7%)	16
Sinus bradycardia	1/838 (0.1%)	1
Sinus tachycardia	1/838 (0.1%)	1
Syncope	1/838 (0.1%)	1
Thromboembolic events	1/838 (0.1%)	1
Transient ischemic attack (TIA)	1/838 (0.1%)	1
Vasovagal reaction	1/838 (0.1%)	1
Ventricular fibrillation (VF)	4/838 (0.5%)	4
Ventricular tachycardia (VT)	9/838 (1.1%)	14
Endocrine disorders
Endocrine	5/838 (0.6%)	5
Gastrointestinal disorders
Gastrointestinal	8/838 (1%)	8
General disorders
Abnormal laboratory values	3/838 (0.4%)	3
Adverse reaction - General	2/838 (0.2%)	2
Head, eyes, ears, nose, throat (HEENT)	10/838 (1.2%)	11
Other- Patient condition - Non- cardiovascular	1/838 (0.1%)	1
Physical trauma	1/838 (0.1%)	1
Infections and infestations
Fever	2/838 (0.2%)	2
Musculoskeletal and connective tissue disorders
Musculoskeletal	10/838 (1.2%)	12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	1/838 (0.1%)	1
Nervous system disorders
Neurological	2/838 (0.2%)	2
Product Issues
Device Deficiency	33/838 (3.9%)	41
Dislodgment - Elevated threshold - LV	2/838 (0.2%)	2
Dislodgment - Elevated threshold -RV	1/838 (0.1%)	1
Dislodgment - Multiple signs - LV	1/838 (0.1%)	1
Dislodgment - No reported signs - RV	1/838 (0.1%)	1
Dislodgment - No reported signs -LV	1/838 (0.1%)	1
Dislodgment - Unable to capture - LV	1/838 (0.1%)	1
Dislodgment - Unable to capture - RA	1/838 (0.1%)	1
Dislodgment - Undersensing - RV	1/838 (0.1%)	1
Elevated threshold - LV	13/838 (1.6%)	14
Elevated threshold - RA	4/838 (0.5%)	5
Elevated threshold - RV	4/838 (0.5%)	4
Extracardiac stimulation - LV	47/838 (5.6%)	55
Extracardiac stimulation - RV	2/838 (0.2%)	3
Impedance > 2000 ohms - LV	1/838 (0.1%)	1
Impedance > 2000 ohms - RA	1/838 (0.1%)	1
Impedance > 2000 ohms - RV	1/838 (0.1%)	1
Inappropriate AV delay	1/838 (0.1%)	1
Inappropriate tachy therapy - Other	1/838 (0.1%)	1
Inappropriate tachy therapy - SVT	5/838 (0.6%)	5
Infection (> 30 days post-implant)	2/838 (0.2%)	2
Other - Lead	4/838 (0.5%)	4
Other - PG system	1/838 (0.1%)	1
Oversensing - RV	1/838 (0.1%)	1
Pacemaker-mediated tachycardia (PMT)	1/838 (0.1%)	1
Rate response inappropriate	1/838 (0.1%)	1
RVAT Communication	6/838 (0.7%)	6
Unable to capture - LV	1/838 (0.1%)	1
Psychiatric disorders
Psychological	2/838 (0.2%)	4
Renal and urinary disorders
Renal	2/838 (0.2%)	2
Reproductive system and breast disorders
Genitourinary	5/838 (0.6%)	5
Respiratory, thoracic and mediastinal disorders
Adverse reaction - Respiratory	1/838 (0.1%)	1
Pulmonary	8/838 (1%)	8
Skin and subcutaneous tissue disorders
Integumentary	4/838 (0.5%)	4
Surgical and medical procedures
Coronary venous dissection	8/838 (1%)	8
Hematoma - Pocket (<= 30 days post-implant)	13/838 (1.6%)	13
Hematoma - Pocket (> 30 days post-implant)	1/838 (0.1%)	1
Other - Lead - Procedure	87/838 (10.4%)	92
Other - PG system - Procedure	10/838 (1.2%)	10
Pleural effusion - Procedure	1/838 (0.1%)	1
Pneumothorax - Procedure	2/838 (0.2%)	2
Post-surgical wound discomfort	6/838 (0.7%)	6
Venous occlusion	1/838 (0.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The 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 less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor can request changes to the communication.