The objective of the study is to demonstrate that in patients with chronic heart failure who receive optimal medical treatment for this condition and have indication for Cardiac Resynchronisation Therapy, the implantation of a pacemaker (index group) is not inferior to defibrillator (control group) with respect to all-cause mortality.
Heart failure is a leading cause of death, hospitalisation, impaired quality of life and health expenditure. Symptoms and survival can be significantly improved by implantation of a device for Cardiac Resynchronisation Therapy (CRT). CRT devices are available as biventricular pacemakers (CRT-P) or as significantly more complex and cost-intensive biventricular defibrillators (CRT-D).
In patients who have previously experienced a life-threatening arrhythmia, the choice of the CRT-D (and not the CRT-P) is imperative but these are a small minority of patients. For the vast majority of patients receiving CRT therapy, there is currently considerable uncertainty as to whether the defibrillator function is needed and whether its benefits outweigh its risks. The defibrillator function may protect patients from sudden cardiac death. On the other hand, device-associated complications such as device infections appear to be increased; furthermore the defibrillator comes along with specific adverse events, particularly inappropriate shocks. These shocks are common and not only traumatic to patients (potentially leading to post-traumatic stress syndrome, anxiety disorders and depression), they also are negatively associated with overall survival.
The objective of the trial is to demonstrate that in patients with chronic heart failure who receive optimal medical treatment for this condition and have indication for CRT, the implantation of a CRT-P (index group) is not inferior to CRT-D (control group) with respect to all-cause mortality. Patients with an indication for CRT will be randomised to CRT-P or CRT-D.
RESET-CRT is an event-driven trial with a planned number of randomised and treated patients of n=1,800 and of 361 primary endpoints within an estimated median follow-up period of 1.69 years.
No investigational medical product is defined to be used within RESET-CRT since only the therapeutic strategy (CRT-D versus CRT-P) is a pre-defined study treatment and allocated by random group (Proof of Strategy Trial). The devices to be implanted will be decided by the treating physician on the basis of the situation of the individual study patient and in line with local policies in routine clinical care.
Total study duration:
Enrolment of 35 months. All patients will be followed until 361 valid primary endpoints are reached (event-driven trial) which is expected about 10 months after last patient in. Total study duration of 45 months (about 4 years) is expected which might be adapted based on blinded interim analysis of the overall occurrence of the primary endpoint.
Individual study duration:
Expected mean follow-up time will be about 1.69 years per patient with a minimum follow-up time of 10 months and a maximum follow-up time of presumably 45 months.
|Treatment||CRT-D Implantation, CRT-P Implantation|
|Clinical Study Identifier||NCT03494933|
|Sponsor||Leipzig Heart Institute GmbH|
|Last Modified on||5 November 2020|
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