CAPTIVATE: Evaluation of Automatic Threshold Algorithms

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02097290
• Collaborator: (none)
• Enrollment: 216
• Locations: 36
• Arm: 1
• Actual Duration (Months): 37
• Patients Per Site: 6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study will evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features for AUTOGEN Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: CRT-D	N/A

Detailed Description

The objective of the CAPTIVATE Clinical Study is to gather data to establish the safety and effectiveness of the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features to support the regulatory approval of the AUTOGEN CRT-D family of devices.

Study Design

• Study Type: Interventional
• Actual Enrollment: 216 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CAPTure Information Via Automatic Threshold Evaluation
• Actual Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CRT-D For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated	Device: CRT-D; For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Outcome Measures

Primary Outcome Measures

1. Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate [3 months]

   Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.

2. The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold. [1-month and 3-month follow-up visits]

   Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: |commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.

3. The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold. [1-month and 3-month follow up visits]

   Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.

4. The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold [1-month and 3-month follow up visits]

   Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:|Ambulatory threshold - ECG threshold| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or |Ambulatory threshold - ECG threshold| ≤ 1.0 V; if the ECG threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.

5. The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold [1-month and 3-month follow up visits]

   Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: |Ambulatory threshold - ECG threshold| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.

Secondary Outcome Measures

1. RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome [3-month follow up visit]

   This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: A device-determined threshold A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above.

2. LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome [3-month follow up visit]

   This endpoint will evaluate the percent of LVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: A device-determined threshold A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the LVAT feature and might not occur in manual threshold tests An appropriate LVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests. An inappropriate LVAT outcome consists of the last of the three outcomes listed above.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects prescribed a CRT-D and indicated per guidelines, who will receive an AUTOGEN CRT-D model G160, G161, G172, G173

2. Subjects who have an implanted functional endocardial right ventricular defibrillation lead or who will receive a endocardial right ventricular defibrillation lead

3. Subjects who have an implanted functional bipolar or unipolar left ventricular lead or who will receive a bipolar or unipolar left ventricular lead

4. Subjects who are willing and capable of providing informed consent to undergo a device implant procedure, and to participate in all testing and follow-ups defined in this protocol

5. Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law

Exclusion Criteria:

1. Subjects who have an implanted multipolar (>2poles) left ventricular lead or who will receive a multipolar (>2poles) left ventricular lead

2. Subjects with an unknown model/manufacturer, or implant date for the RA, RV or LV lead

3. Subjects for whom a RV defibrillation lead manufactured by St. Jude Medical or Biotronik is implanted, is planned to be implanted, or has been abandoned

4. Implanted with an active Medtronic Sprint Fidelis® lead models: 6930, 6931, 6948 or 6949

5. Subjects with an implanted or abandoned St. Jude Medical QuickSite® or QuickFlex® lead models: 1056T, 1058T, 1156T, 1158T

6. Subjects with a RV or LV lead revision or extraction within 30 days of enrollment

7. Subjects with an implanted lead that is planned to be extracted during the study implant procedure

8. Subjects with an active implanted RA or RV lead that is greater than 10 years old, unless the lead will be abandoned

9. Subjects with an active implanted LV lead that is greater than 8 years old, unless the lead will be abandoned

10. Subjects preexisting unipolar pacemaker that will not be explanted/abandoned

11. Subjects with a life expectancy less than 6 months

12. Subjects with a prosthetic mechanical tricuspid heart valve

13. Women of childbearing age who are pregnant or plan to become pregnant. NOTE: women of childbearing potential with an uncertain pregnancy status must have a negative pregnancy test within 7 days prior to enrollment. Pregnancy tests are required as part of standard routing clinical practice at all centers whenever female patients are exposed to x-ray radiation. Since this protocol does not require any exposure of the female patients to x-ray and x-ray exposure is part of the clinical procedure, it is the responsibility of the investigators to ensure that pregnant females will not be exposed to x-ray at any time

14. Subject enrolled in a concurrent study, except national/governmental registries that do not require a signed informed consent form, without the written approval from Boston Scientific

15. Subjects who are not geographically stable, to the extent that it would prevent attending the study follow-ups at the investigational center

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glendale Adventist Medical Center	Glendale	California	United States	91204
2	Danbury Hospital	Danbury	Connecticut	United States	06810
3	Washington Hospital Center	Washington	District of Columbia	United States	20010
4	Delray Medical Center	Atlantis	Florida	United States	33462
5	St. Vincent's Medical Center	Jacksonville	Florida	United States	32204
6	Baptist Medical Center	Jacksonville	Florida	United States	32207
7	First Coast Cardiovascular	Jacksonville	Florida	United States	32216
8	Orlando Regional Medical Center	Orlando	Florida	United States	32806
9	University Community Hospital	Trinity	Florida	United States	34655
10	Winter Haven Hospital	Winter Haven	Florida	United States	33881
11	Carle Foundation Hospital	Urbana	Illinois	United States	61801
12	IU Health LaPorte	LaPorte	Indiana	United States	46350
13	St. Luke's Hospital	Cedar Rapids	Iowa	United States	52043
14	University of Iowa Hospitals and Clinics	Davenport	Iowa	United States	52803
15	Via-Christi Regional Medical Center	Wichita	Kansas	United States	67208
16	Norton Cardiovascular Associates	Louisville	Kentucky	United States	40205
17	University of Maryland Medical System	Baltimore	Maryland	United States	21201
18	Steward St. Elizabeth's Medical Center of Boston, Inc.	Boston	Massachusetts	United States	02135
19	St. John Hospital & Medical Center	Detroit	Michigan	United States	48236
20	Sparrow Health System	Lansing	Michigan	United States	48912
21	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
22	Cox Health	Springfield	Missouri	United States	65807
23	St. Patrick Hospital	Missoula	Montana	United States	59802
24	Rochester General Hospital	Rochester	New York	United States	14621
25	Wake Medical Center	Raleigh	North Carolina	United States	27610
26	Summa Health System	Akron	Ohio	United States	44034
27	Lindner Center for Research and Education	Cincinnati	Ohio	United States	45219
28	St. Elizabeth Health Center	Poland	Ohio	United States	44514
29	Good Samaritan Hospital	Lebanon	Pennsylvania	United States	17042
30	University Medical Center-Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
31	Seton Medical Center	Austin	Texas	United States	78705
32	Cardiology Clinic of San Antonio	San Antonio	Texas	United States	78229
33	University of Utah Hospital and Clinics	Salt Lake City	Utah	United States	84132
34	Virginia Commonwealth University Health	Richmond	Virginia	United States	23298
35	PeaceHealth Southwest Medical	Vancouver	Washington	United States	98664
36	St. Mary's Medical Center	Huntington	West Virginia	United States	25702

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Kenneth Ellenbogen, MD, Virginia Commonwealth University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT02097290
• Other Study ID Numbers: CAPTIVATE; IDE# G130241
• First Posted: Mar 27, 2014
• Last Update Posted: Apr 19, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Boston Scientific Corporation: Threshold algorithms; CRT-D
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	CRT-D
Arm/Group Description	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Period Title: Overall Study
STARTED	210
COMPLETED	193
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	CRT-D
Arm/Group Description	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Overall Participants	210
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.8 (10.8)
Sex: Female, Male (Count of Participants)
Female	70 33.3%
Male	140 66.7%
Race/Ethnicity, Customized (Count of Participants)
Hispanic/Latino	8 3.8%
Multiple Races	3 1.4%
Asian	1 0.5%
Black	25 11.9%
Other	1 0.5%
White	170 81%
Undisclosed	2 1%
Region of Enrollment (Count of Participants)
United States	210 100%

Outcome Measures

1. Primary Outcome

Title	Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate
Description	Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Implant + Attempt Subjects

Arm/Group Title	CRT-D
Arm/Group Description	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Measure Participants	210
Number (95% Confidence Interval) [Percentage of participants]	84.2 40.1%

2. Primary Outcome

Title	The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
Description	Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: |commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.
Time Frame	1-month and 3-month follow-up visits

Outcome Measure Data

Analysis Population Description

A total of 288 paired datasets (from 171 unique subjects in whom RVAT threshold was available), each dataset consisting of a commanded RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.

Arm/Group Title	CRT-D
Arm/Group Description	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Measure Participants	171
Measure Commanded RVAT thresholds paired dataset	288
Number (95% Confidence Interval) [percentage of commanded RVAT thresholds]	97.9

3. Primary Outcome

Title	The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.
Description	Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis.
Time Frame	1-month and 3-month follow up visits

Outcome Measure Data

Analysis Population Description

A total of 324 paired datasets (from 182 unique subjects in whom LVAT threshold was available), each dataset consisting of a commanded LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.

Arm/Group Title	CRT-D
Arm/Group Description	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Measure Participants	182
Measure Commanded LVAT thresholds-paired dataset	324
Number (95% Confidence Interval) [Percentage of commanded LVAT thresholds]	97.8

4. Primary Outcome

Title	The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
Description	Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:|Ambulatory threshold - ECG threshold| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or |Ambulatory threshold - ECG threshold| ≤ 1.0 V; if the ECG threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.
Time Frame	1-month and 3-month follow up visits

Outcome Measure Data

Analysis Population Description

A total of 314 paired datasets (from 183 unique subjects in whom RVAT threshold was available), each dataset consisting of an ambulatory RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.

Arm/Group Title	CRT-D
Arm/Group Description	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Measure Participants	183
Measure RVAT ambulatory threshold paired dataset	314
Number (95% Confidence Interval) [Percentage of RVAT ambulatory thresholds]	99.0

5. Primary Outcome

Title	The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold
Description	Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: |Ambulatory threshold - ECG threshold| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis.
Time Frame	1-month and 3-month follow up visits

Outcome Measure Data

Analysis Population Description

A total of 300 paired datasets (from 175 unique subjects in whom LVAT threshold was available), each dataset consisting of a ambulatory LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.

Arm/Group Title	CRT-D
Arm/Group Description	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Measure Participants	175
Measure LVAT ambulatory threshold paired dataset	300
Number (95% Confidence Interval) [Percentage of accurate threshold]	97.7

6. Secondary Outcome

Title	RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome
Description	This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: A device-determined threshold A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above.
Time Frame	3-month follow up visit

Outcome Measure Data

Analysis Population Description

A total of 157 unique subjects in whom a paired RVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an RVAT threshold test outcome and core lab determined threshold test outcome.

Arm/Group Title	CRT-D
Arm/Group Description	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Measure Participants	157
Number (95% Confidence Interval) [percentage of appropriate outcome]	85.4

7. Secondary Outcome

Title	LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome
Description	This endpoint will evaluate the percent of LVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test: A device-determined threshold A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the LVAT feature and might not occur in manual threshold tests An appropriate LVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests. An inappropriate LVAT outcome consists of the last of the three outcomes listed above.
Time Frame	3-month follow up visit

Outcome Measure Data

Analysis Population Description

A total of 182 unique subjects in whom a paired LVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an LVAT threshold test outcome and core lab determined threshold test outcome.

Arm/Group Title	CRT-D
Arm/Group Description	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
Measure Participants	182
Number (95% Confidence Interval) [percentage of appropriate outcome]	95.1

Adverse Events

Time Frame	Adverse events reported were collected from ICF signature until the last study follow-up.
Arm/Group Title	CRT-D
Arm/Group Description	CRT-D: For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated. Subjects in whom AUTOGEN CRT-D was successfully implanted or an attempt to implant made were considered to be at risk for adverse events. There were a total of 210 implants and attempts.
All Cause Mortality
	CRT-D
	Affected / at Risk (%)	# Events
Total	17/210 (8.1%)
Serious Adverse Events
	CRT-D
	Affected / at Risk (%)	# Events
Total	101/210 (48.1%)
Blood and lymphatic system disorders
Abnormal Laboratory Values	2/210 (1%)	2
Hematological	4/210 (1.9%)	5
Cardiac disorders
Adverse Reaction - Hypotension	2/210 (1%)	2
Arterial/Venous Trombolytic Event	1/210 (0.5%)	1
Atrial Fibrillation (Af)	7/210 (3.3%)	8
Atrial Flutter	5/210 (2.4%)	5
Atrial Tachyarrhythmias	1/210 (0.5%)	1
Cardiac Arrest	8/210 (3.8%)	8
Cardiogenic Shock	1/210 (0.5%)	1
Chest Pain - Ischemic	3/210 (1.4%)	3
Chest Pain - Other	3/210 (1.4%)	3
Coronary Artery Disease	1/210 (0.5%)	2
Coronary Venous Perforation Without Tamponade	1/210 (0.5%)	1
Dislodgment - Elevated Threshold - Rv	1/210 (0.5%)	1
Dislodgment - Extracardiac Stimulation - Lv	1/210 (0.5%)	1
Dislodgment - Multiple Signs - Rv	1/210 (0.5%)	2
Dislodgment - No Reported Signs - Lv	3/210 (1.4%)	3
Dislodgment - No Reported Signs - Ra	1/210 (0.5%)	1
Dislodgment - Unable To Capture - Lv	3/210 (1.4%)	3
Dislodgment - Unable To Capture - Ra	1/210 (0.5%)	1
Dyspnea - Heart Failure	9/210 (4.3%)	13
Elevated Threshold - Lv	1/210 (0.5%)	1
Extracardiac Stimulation - Lv	5/210 (2.4%)	5
Gastrointestinal - Heart Failure	1/210 (0.5%)	1
Heart Failure Symptoms - Unspecified	6/210 (2.9%)	6
Hypotension	2/210 (1%)	2
Hypotension - Heart Failure	1/210 (0.5%)	1
Impedance < 300 Ohms - Ra	1/210 (0.5%)	1
Inadvertent Vt/Vf	1/210 (0.5%)	1
Inappropriate Tachy Therapy - Svt	2/210 (1%)	2
Intracardiac Thrombus	1/210 (0.5%)	1
Mitral Regurgitation	1/210 (0.5%)	1
Multi-System Failure - Heart Failure	5/210 (2.4%)	5
Multiple Heart Failure Symptoms	25/210 (11.9%)	34
Myocardial Infarction	4/210 (1.9%)	4
Myocardial Perforation Post-Implant - Rv	1/210 (0.5%)	1
Myocardial Perforation With Tamponade	1/210 (0.5%)	1
Other-Lead-Procedure	2/210 (1%)	2
Palpitations	1/210 (0.5%)	1
Pericardial Effusion	2/210 (1%)	2
Peripheral Edema - Heart Failure	1/210 (0.5%)	1
Pleural Effusion	1/210 (0.5%)	2
Pneumothorax - Procedure	4/210 (1.9%)	4
Premature Ventricular Contractions (Pvc)	1/210 (0.5%)	1
Sinus Tachycardia	1/210 (0.5%)	1
Syncope	3/210 (1.4%)	3
Unable To Capture - Lv	1/210 (0.5%)	1
Unable To Convert - Defibrillation	1/210 (0.5%)	1
Ventricular Fibrillation (Vf)	2/210 (1%)	2
Ventricular Flutter	1/210 (0.5%)	1
Ventricular Tachycardia (Vt)	3/210 (1.4%)	4
Failure To Implant Epicardial Lv Lead	1/210 (0.5%)	1
Inability To Place The Lv Lead	1/210 (0.5%)	1
Left Chest Wall Emphysema	1/210 (0.5%)	1
ICD shocks	2/210 (1%)	2
Unable To Insert Lv Lead With Initial Procedure	1/210 (0.5%)	1
Ear and labyrinth disorders
Migration	1/210 (0.5%)	1
Vestibulitis	1/210 (0.5%)	1
Endocrine disorders
Endocrine	4/210 (1.9%)	5
Eye disorders
Cataract	2/210 (1%)	2
Gastrointestinal disorders
Gastrointestinal	14/210 (6.7%)	17
General disorders
Dizziness	1/210 (0.5%)	1
Angioedema	1/210 (0.5%)	1
Patient Death - unknown cause	1/210 (0.5%)	1
Immune system disorders
Multi-System Failure	1/210 (0.5%)	1
Multiple Symptoms	1/210 (0.5%)	1
Infections and infestations
Infection (> 3 Days Post-Implant)	1/210 (0.5%)	1
Systemic Infection	4/210 (1.9%)	5
Severe Rt. Leg Stump Infection	1/210 (0.5%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal	4/210 (1.9%)	6
Physical Trauma	3/210 (1.4%)	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	4/210 (1.9%)	4
Nervous system disorders
Neurological	4/210 (1.9%)	5
Psychiatric disorders
Psychological	1/210 (0.5%)	1
Renal and urinary disorders
Genitourinary	7/210 (3.3%)	7
Renal	7/210 (3.3%)	8
Renal Failure Due To Contrast Media - Procedure	1/210 (0.5%)	1
Renal Insufficiency - Heart Failure	1/210 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
Adverse Reaction - Respiratory	3/210 (1.4%)	3
Copd Exacerbation	3/210 (1.4%)	4
Pulmonary	14/210 (6.7%)	23
Pulmonary Edema	1/210 (0.5%)	1
Pulmonary Edema - Heart Failure	2/210 (1%)	2
Shortness of breath	1/210 (0.5%)	1
Skin and subcutaneous tissue disorders
Skin rash	1/210 (0.5%)	1
Hematoma - Pocket (<=30 Days Post-Implant)	2/210 (1%)	2
Integumentary	1/210 (0.5%)	1
Post-Surgical Wound Discomfort	2/210 (1%)	2
Vascular disorders
Cerebrovascular Accident (Cva)	1/210 (0.5%)	1
Peripheral Vascular Disease	3/210 (1.4%)	3
Left Leg Ischemia	1/210 (0.5%)	1
Other (Not Including Serious) Adverse Events
	CRT-D
	Affected / at Risk (%)	# Events
Total	81/210 (38.6%)
Blood and lymphatic system disorders
Hematological	6/210 (2.9%)	6
Cardiac disorders
Hypotension	2/210 (1%)	2
Atrial Fibrillation	11/210 (5.2%)	12
Atrial Flutter	3/210 (1.4%)	3
Atrial Tachyarrhythmias	2/210 (1%)	2
Unable to perform Threshold test-RV	1/210 (0.5%)	1
Chest Pain-Ischemic	1/210 (0.5%)	1
Chest Pain-Other	5/210 (2.4%)	5
Coronary Venous Dissection	2/210 (1%)	2
Dislodgment-extracardiac stimulation-RA	1/210 (0.5%)	1
Dislodgment-LV	1/210 (0.5%)	1
Dislodgment-unable to capture-LV	1/210 (0.5%)	1
Dislodgment-unable to capture-RV	1/210 (0.5%)	1
Dyspnea-heart failure	3/210 (1.4%)	3
Extracardiac stimulation-LV	28/210 (13.3%)	30
Hypertension	1/210 (0.5%)	1
Hypotension	1/210 (0.5%)	1
Insulation breach-RV	1/210 (0.5%)	1
Mitral regurgitation	1/210 (0.5%)	1
Multiple Heart Failure Symptoms	5/210 (2.4%)	7
Myocardial Infarction	1/210 (0.5%)	1
Nonsustained Ventricular Tachycardia	2/210 (1%)	2
Other PG-system-procedure	1/210 (0.5%)	1
Cardiovascular event	1/210 (0.5%)	1
Oversensing-RV	1/210 (0.5%)	1
Pacemaker Mediated Tachycardia	8/210 (3.8%)	8
Palpitations	1/210 (0.5%)	1
Peripheral edema-heart failure	2/210 (1%)	2
PG system-event	1/210 (0.5%)	1
Premature ventricular contractions	1/210 (0.5%)	1
Sinus Tachycardia	1/210 (0.5%)	1
Syncope	1/210 (0.5%)	1
Thromboembolic events	1/210 (0.5%)	1
Transient Ischemic Attack	1/210 (0.5%)	1
Unable to capture-LV lead	2/210 (1%)	2
Undersensing-RA	1/210 (0.5%)	1
Ventricular Tacchyarrhythmias	1/210 (0.5%)	1
ICD shocks	1/210 (0.5%)	1
Low LVEF	1/210 (0.5%)	1
High LV lead impedance	1/210 (0.5%)	1
High RV lead impedance	1/210 (0.5%)	1
Low pacing output	1/210 (0.5%)	1
Ear and labyrinth disorders
Ear reaction	1/210 (0.5%)	2
Cerumen impaction	1/210 (0.5%)	1
Endocrine disorders
Endocrine	5/210 (2.4%)	5
Eye disorders
Visual disturbances	2/210 (1%)	3
Gastrointestinal disorders
Gastrointestinal	8/210 (3.8%)	10
General disorders
Abnormal Laboratory Values	7/210 (3.3%)	10
Delirium	1/210 (0.5%)	1
Dizziness	4/210 (1.9%)	4
Fatigue	1/210 (0.5%)	1
Weight Gain	1/210 (0.5%)	1
Adverse Drug Reaction	1/210 (0.5%)	1
Cocaine Abuse	1/210 (0.5%)	1
Immune system disorders
Immune disorder	1/210 (0.5%)	1
Infections and infestations
Post surgical infection	1/210 (0.5%)	1
Musculoskeletal and connective tissue disorders
Muskuloskeletal	14/210 (6.7%)	16
Physical Trauma	11/210 (5.2%)	12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	3/210 (1.4%)	3
Nervous system disorders
Neurological	3/210 (1.4%)	4
Psychiatric disorders
Psychological	2/210 (1%)	3
Psychological effect due to device therapy	2/210 (1%)	2
Renal and urinary disorders
Genitorurinary	10/210 (4.8%)	11
Renal	1/210 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
COPD	3/210 (1.4%)	3
Pulmonary	14/210 (6.7%)	14
Skin and subcutaneous tissue disorders
Allergic Reaction	1/210 (0.5%)	1
Hematoma (less than 30 days post implant)	7/210 (3.3%)	7
Integumentary	8/210 (3.8%)	8
Post-surgical Pocket Hemorhage	1/210 (0.5%)	1
Post-surgical wound discomfort	9/210 (4.3%)	9
Swollen neck	1/210 (0.5%)	1
Vascular disorders
Peripheral vascular disease	1/210 (0.5%)	1
Venous Occlusion	1/210 (0.5%)	1

Limitations/Caveats

The RVAT and LVAT endpoints are compared against a performance goal rather than to a randomized control arm.

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.