NCT02222818

Cardiac Resynchronization Therapy Efficacy Enhancements

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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 30 centers located in the United States, Europe and Middle East and Africa (MEA).

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Conducted AF Response (CAFR)	The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
DEVICE	Conducted AF Response Plus (CAFRPlus)	The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-08-21
• Last updated: 2017-01-06
• Results posted: 2017-01-06

Locations

19 sites across 7 countries: United States, Hungary, Italy, Saudi Arabia, Slovakia, South Africa, United Kingdom