Evaluation of Automatic Threshold Algorithms

CAPTure Information Via Automatic Threshold Evaluation

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.

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.

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