Last updated on January 2020

Re-evaluation of Optimal Re-synchronisation Therapy in Patients With Chronic Heart Failure

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Heart Failure
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age 18 years.
  • Symptomatic chronic heart failure due to ischemic or non-ischemic cardiomyopathy with NYHA class II, III or ambulatory IV.
  • Reduced left ventricular ejection fraction 35% in transthoracic echocardiography.
  • On Optimal Medical Therapy (OMT) for at least 3 months prior to enrolment.
  • Class I or IIa indication for implantation of an active device for cardiac resynchronisation therapy (according to 2016 Guidelines of the European Society of Cardiology for the diagnosis and treatment of acute and chronic heart failure).
  • Signed informed consent.

Exclusion criteria

  • Class I or IIa indication for implantation of an ICD for secondary prevention of sudden cardiac death and ventricular tachycardia (according to the 2015 Guidelines of the European Society of Cardiology for the management of patients with ven-tricular arrhythmias and the prevention of sudden cardiac death).
  • Indication for implantation of a cardiac pacemaker due to bradycardia (according to the 2013 Guidelines of the European Society of Cardiology on cardiac pacing and cardiac resynchronization therapy).
  • Ventricular tachycardia induced in an electrophysiological study.
  • Carrying any implanted cardiac pacemaker, defibrillator or CRT device.
  • Unexplained syncope.
  • Hospitalised with unstable heart failure with NYHA class IV within 1 month prior to enrolment.
  • Acute coronary syndrome or cardiac revascularization therapy by coronary angioplasty or coronary ar-tery bypass grafting within 3 months prior to enrolment.
  • Cardiac valve surgery or percutaneous cardiac valvular intervention such as transcatheter aortic valve replacement or transcatheter mitral valve repair performed within 3 months prior to enrolment.
  • Reversible non-ischemic cardiomyopathy such as acute viral myocarditis or discontinuation of alcohol in alcohol-induced heart disease.
  • On the waiting list for heart transplant.
  • Any disease that limits life expectancy to less than 2 years.
  • Severe chronic renal disease (GFR<15 ml/min and/or the need for dialysis)
  • Participation in another clinical trial, either within the past 3 months or still ongoing (participation in sub-studies connected to this trial is permitted).
  • Previous participation in RESET-CRT.
  • Pregnant women or women of childbearing potential not on adequate birth control.
  • Drug abuse or clinically manifest alcohol abuse.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.