Evaluation of Automatic Threshold Algorithms

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: CRT-D

• Registration Number: NCT02097290
• Lead Sponsor: Boston Scientific Corporation

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.

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 Timeline

• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-27
• Study Start: 2014-04
• Primary Completion: 2016-01
• Results First Submitted: 2017-03-09
• Study Completion: 2017-05
• Results First Submitted QC: 2017-08-02
• Results First Posted: 2017-09-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRT-D	CRT-D	For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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

Name	Time	Method
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: 1. A device-determined threshold; 2. 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; 3. 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.
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: 1. A device-determined threshold; 2. 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; 3. 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.

Trial Locations

Locations (36)

Glendale Adventist Medical Center; 🇺🇸 Glendale, California, United States

Danbury Hospital; 🇺🇸 Danbury, Connecticut, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Delray Medical Center; 🇺🇸 Atlantis, Florida, United States

St. Vincent's Medical Center; 🇺🇸 Jacksonville, Florida, United States

Baptist Medical Center; 🇺🇸 Jacksonville, Florida, United States

First Coast Cardiovascular; 🇺🇸 Jacksonville, Florida, United States

Orlando Regional Medical Center; 🇺🇸 Orlando, Florida, United States

University Community Hospital; 🇺🇸 Trinity, Florida, United States

Winter Haven Hospital; 🇺🇸 Winter Haven, Florida, United States

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