Aims and Methods
Each year in Europe, approximately 80.000 patients diagnosed with severe heart failure and a QRS duration of ≥130ms receive a new cardiac resynchronisation therapy (CRT) device. Unfortunately, a third of these patients do not seem to benefit from it. In Europe alone, this represents an annual cost of 50 to 117 million euros on devices that may not improve patient outcome. In addition, one in ten recipients require re-intervention during the first six months after implantation. To avoid excessive costs and complications a better approach to selecting patients without affecting the treatment efficacy is necessary.
In retrospective and observational studies we were able to distinguish patients who benefited most from CRT using two echocardiographic criteria of left ventricular mechanical dyssynchrony: (1) septal flash, a rapid inward motion of the septum during pre-ejection systole, and (2) apical rocking, a septal-to-lateral motion of the apex during systole. Patients who exhibited these motion patterns on echocardiography before CRT implantation improved more and lived longer compared to patients who did not express these patterns. However, none of those studies included a control group and could therefore not be used to determine whether patients should have septal flash or apical rocking to be eligible for CRT.
Therefore, we designed the AMEND-CRT trial as an international, randomised, double-blind, sham-controlled, non-inferiority trial to determine if septal flash or apical rocking should be present in addition to the current ECG criteria to be considered for CRT. To participate in the trial, patients must be eligible for CRT according to the latest ESC guidelines. Patients are randomised 1:1 to an active control arm (“Guideline Arm”) or an experimental arm (“Echo Arm”). All patients receive a CRT device, however, in the Echo Arm, CRT is activated only if the patient has either septal flash or apical rocking. The results of both arms will be compared after one year.
Expected results and perspectives
The AMEND-CRT trial will determine if septal flash and apical rocking are to be the cornerstone for CRT patient selection. If the trial results are positive, we will have demonstrated that a more stringent selection procedure can achieve at least similar results to the current ECG-based guidelines. This will lead to less device implantations, reducing excessive costs and complications.
Current status
01 April 2026: Recruitment for AMEND-CRT is now completed. 500 patients have been recruited.
Results of this echo-based RCT are expected by mid-2027.
For more information and for the latest status on the project, visit https://clinicaltrials.gov/study/NCT04225520
This trial is registered at ClinicTrials.gov with identifier NCT04225520.