AMEND-CRT
Research type
Research Study
Full title
Assessment of MechaNical Dyssynchrony as Selection Criterion for Cardiac Resynchronization Therapy.
IRAS ID
297741
Contact name
Alexis Puvrez
Contact email
Sponsor organisation
Catholic University of Leuven
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 11 months, 28 days
Research summary
26 million people suffer from heart failure worldwide. 1 out 4 will develop a conduction delay which will further deteriorate their clinical status. In the 90's a therapy was developed to overcome the conduction delay using a special pacemaker device. The so called cardiac resynchronization therapy (CRT). CRT was shown to strongly improve both quality of life and life expectancy. Unfortunately 1 out of 3 patients will show no signs of improvement after receiving the device. This percentage of "non-responders" has persisted despite numerous technological improvements and almost two decades of clinical experience. These patients are needlessly being exposed to the risks associated with the introduction of foreign objects in the human body (in the vicinity of the heart). CRT is also expensive - a cost 10 times greater than the cost of oral heart failure therapy. And, disturbingly, some studies suggest CRT might actually decrease quality of life and life expectancy in non-responders. It is therefore crucial to select the right patients for benefitting from CRT.
Our research centre developed a new method for selecting patients using conventional echocardiography. A non-invasive imaging technique. By searching for specific motion patterns on these dynamic images of the heart, we believe we can improve the current guidelines. We believe we are able to increase the number of patients actually benefitting from CRT and reduce the number of pointless interventions. This hypothesis has already been confirmed in several retrospective and prospective studies performed by different research centres.
Now is the time for a robust prospective clinical trial to change the guidelines. We will therefore co-operate with 29 hospitals from 19 countries to perform a single-blinded, randomized, non-inferiority trial comparing our new method to the current guidelines in 700 patients. The AMEND-CRT study.
REC name
Wales REC 1
REC reference
22/WA/0345
Date of REC Opinion
11 Jan 2023
REC opinion
Further Information Favourable Opinion