Captivate

CAPTure Information Via Automatic Threshold Evaluation

Captivate [NCT02097290]

Description: 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.

Device: CRT-D

Primary Investigator: Schloss

Drug/Device Information
To evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features to support the regulatory approval of the Autogen family of devices
Non-randomized
Boston Scientific CRM
Major Inclusion and Exclusion
Subjects prescribed a CRT-D and indicated per guidelines, who will receive an AUTOGEN CRT-D model G160, G161, G172, G173
No implanted multipolar (>2poles) left ventricular lead or who will receive a multipolar (>2poles) left ventricular lead
No implanted lead that is planned to be extracted during the study implant procedure
No active implanted RA or RV lead that is greater than 10 years old
No active implanted LV lead that is greater than 8 years old, unless the lead will be abandoned