Personalised Risk scOre For Implantation of Defibrillators in Patients With Reduced LVEF≤35% and a Low Risk for Sudden Cardiac Death

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to demonstrate that in post-MI patients with symptomatic heart failure who receive optimal medical therapy for this condition, and with reduced LVEF ≤ 35% but low risk for SCD according to a personalised risk score, optimal medical therapy without ICD implantation (index group) is not inferior to optimal medical therapy with ICD implantation (control group) with respect to all-cause mortality.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leipzig Heart Institute GmbH

Criteria

Inclusion Criteria:

• Age ≥18 years.

• Documented history of myocardial infarction either as ST segment elevation myocardial infarction (STEMI) or as non-ST segment elevation myocardial infarction (NSTEMI).

• Symptomatic heart failure with NYHA class II or III.

• On Optimal Medical Therapy (OMT) for at least 3 months prior to enrolment.

• LVEF ≤ 35% at transthoracic echocardiography or cardiac magnetic resonance imaging (MRI).

• Predicted personalised annual risk of SCD according to the clinical risk calculator ≤2.5%.

• 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 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death, see Appendix V).

• Ventricular tachycardia induced in an electrophysiologic study.

• Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.

• Conclusive clinical indication for CRT (class I or IIa indication according to the 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure)

• Carrying any implanted cardiac pacemaker, defibrillator or CRT device.

• Violation of instruction for use (IFU) of the selected ICD device by at least one of the random group treatments.

• 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 artery 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.

• On the waiting list for heart transplantation.

• Any known disease that limits life expectancy to less than 1 year.

• Participation in another clinical trial, either within the 3 months prior to enrolment or still on-going (participation in sub-studies connected to this trial is permitted).

• Previous participation in PROFID-Reduced.

• Drug abuse or clinically manifest alcohol abuse.