Overview

This trial is active, not recruiting.

Condition heart failure
Treatment crt-d
Sponsor Boston Scientific Corporation
Start date April 2014
End date January 2016
Trial size 216 participants
Trial identifier NCT02097290, CAPTIVATE, IDE# G130241

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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

Primary Outcomes

Measure
Primary Safety Endpoint is to evaluate the system-related complication-free rate
time frame: 3 months
The accuracy of the RVAT Commanded test will be evaluated by comparing the RVAT determined threshold to a core lab (independent physician) determined threshold.
time frame: 3 months
The accuracy of the LVAT Commanded test will be evaluated by comparing the LVAT determined threshold to a core lab (independent physician) determined threshold.
time frame: 3 months
The accuracy of the RVAT Ambulatory test will be evaluated by comparing the RVAT determined threshold to a core lab (independent physician) determined threshold
time frame: 3 months
The accuracy of the LVAT Ambulatory test will be evaluated by comparing the LVAT determined threshold to a core lab (independent physician) determined threshold
time frame: 3 months

Secondary Outcomes

Measure
RVAT Secondary Efficacy Endpoint: The percent of RVAT commanded tests that result in an appropriate outcome
time frame: 3 months
LVAT Secondary Efficacy Endpoint: The percent of LVAT commanded tests that result in an appropriate outcome
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title CAPTure Information Via Automatic Threshold Evaluation
Principal investigator Kenneth Ellenbogen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.