Evaluation of Automatic Threshold Algorithms (CAPTIVATE)

Boston Scientific

Status

Completed

Conditions

Heart Failure

Treatments

Device: CRT-D

Study type

Interventional

Funder types

Industry

Identifiers

NCT02097290

IDE# G130241 (Other Identifier)

CAPTIVATE

Details and patient eligibility

About

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.

Full 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.

Enrollment

216 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects prescribed a CRT-D and indicated per guidelines, who will receive an AUTOGEN CRT-D model G160, G161, G172, G173
Subjects who have an implanted functional endocardial right ventricular defibrillation lead or who will receive a endocardial right ventricular defibrillation lead
Subjects who have an implanted functional bipolar or unipolar left ventricular lead or who will receive a bipolar or unipolar left ventricular lead
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
Subjects whose age is 18 or above, or of legal age to give informed consent specific to national law

Exclusion criteria

Subjects who have an implanted multipolar (>2poles) left ventricular lead or who will receive a multipolar (>2poles) left ventricular lead
Subjects with an unknown model/manufacturer, or implant date for the RA, RV or LV lead
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
Implanted with an active Medtronic Sprint Fidelis® lead models: 6930, 6931, 6948 or 6949
Subjects with an implanted or abandoned St. Jude Medical QuickSite® or QuickFlex® lead models: 1056T, 1058T, 1156T, 1158T
Subjects with a RV or LV lead revision or extraction within 30 days of enrollment
Subjects with an implanted lead that is planned to be extracted during the study implant procedure
Subjects with an active implanted RA or RV lead that is greater than 10 years old, unless the lead will be abandoned
Subjects with an active implanted LV lead that is greater than 8 years old, unless the lead will be abandoned
Subjects preexisting unipolar pacemaker that will not be explanted/abandoned
Subjects with a life expectancy less than 6 months
Subjects with a prosthetic mechanical tricuspid heart valve
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
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
Subjects who are not geographically stable, to the extent that it would prevent attending the study follow-ups at the investigational center