CRTee

ClinicalTrials.gov Identifier: NCT02222818

Purpose

The purpose of this study is to demonstrate that the amount of effective CRT (Cardiac Resynchronization Therapy) pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.

Condition: Atrial Fibrillation

Intervention:      

Device: Conducted AF Response Plus (CAFRPlus)
Device: Conducted AF Response (CAFR)

Official Title: Cardiac Resynchronization Therapy Efficacy Enhancements (CRTee)

Arms: Active Comparator: Conducted AF Response (CAFR)

CAFR is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes

Or

Experimental: Conducted AF Response Plus (CAFRPlus)

The CAFRPlus algorithm is part of the CRTee feature set. The feature set will also provide data on the percentage of effective CRT pacing when the subject is in AF or not in AF (diagnostic information)

 
Detailed Description:

The CRTee study is an IDE, prospective, multi-center, randomized, controlled, crossover clinical study, conducted worldwide and designed to demonstrate that the amount of effective CRT pacing during AF (atrial fibrillation) when CAFRPlus (Conducted AF Response Plus) is applied is not inferior to the amount of effective CRT pacing during AF when CAFR (Conducted AF Response) is applied.

The study will be conducted at up to 20 centers located in the United States, Europe and Middle East and Africa (MEA).