CRTee version 3
Research type
Research Study
Full title
Cardiac Resynchronization Therapy Efficacy Enhancements (CRTee)
IRAS ID
162206
Contact name
Chris Plummer
Contact email
Sponsor organisation
Medtronic Inc.
Research summary
The Cardiac Resynchronization Therapy Efficacy Enhancements (CRTee) study will be conducted in approximately 20 centres worldwide. Up to 75 patients will be enrolled and followed up for 4 months. The expected total study duration is 19 months, representing 15 months of enrolment and 4 months for the last patient follow-up.
The heart is a muscular pump with collecting chambers (atria) and main pumping chambers (ventricles). In normal heart rhythm, the atria contract to move blood into the ventricles. Atrial Fibrillation (AF) is a common abnormal heart rhythm where the atria do not contract normally and fibrillate (quiver). This can lead to symptoms such as breathlessness and palpitations due an irregular heart rhythm.
The study is being conducted in patients who have previously undergone the implantation of a Medtronic "Viva" or "Brava" Cardiac Resynchronization Therapy-Defibrillator (CRT-D) for heart failure. The performance of a novel algorithm (CAFRPlus - Conducted AF Response Plus) will be compared with the standard CE-marked algorithm (CAFR - Conducted AF Response). Both algorithms are designed to promote effective delivery of Cardiac Resynchronization Therapy (CRT) pacing during AF episodes.
Patients who have previously undergone device implantation for clinical reasons, will be invited to take part in the study. These devices already contain the CAFR (Control) algorithm as CE-marked standard. CAFRPlus (Treatment) will be downloaded into the device using an external computer called a programmer as a "CRTee feature set".
Patients will be randomised in a 1:1 ratio to CAFR or CAFRPlus and then crossover to the other algorithm. Following the crossover phase a Final visit will be scheduled (approximately 4 months post-randomisation) that may be combined with the study exit.
REC name
North East - York Research Ethics Committee
REC reference
14/NE/1109
Date of REC Opinion
23 Sep 2014
REC opinion
Favourable Opinion