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RECRUITING
NCT05373940
NA

Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.

Official title: Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

730

Start Date

2022-06-29

Completion Date

2030-05-31

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

DEVICE

ICD implantation

This group will undergo an ICD implantation (type and manufacturer at the discretion of the local investigator) in addition to heart failure medical therapy optimization. Patients of the "HFOT+ICD" group will be scheduled for ICD implantation.

DEVICE

No ICD implantation

Patients of the "HFOT alone" group will not undergo ICD implantation (except if they develop sustained ventricular arrhythmias and fulfil for secondary prevention ICD implantation), and continue with medical therapy optimization only.

Locations (19)

Centre Hospitalier d'Aix en provence

Aix-en-Provence, France

CHU Amiens-Picardie-Site sud

Amiens, France

CHU Brest - Hôpital La Cavale Blanche

Brest, France

HôpitalHenri Mondor

Créteil, France

CHU Grenoble Alpes

La Tronche, France

Groupement d'Hôpitaux de l'Institut Catholique de Lille

Lomme, France

Hôpital de La Timone

Marseille, France

Hôpital de Brabois

Nancy, France

CHU de Nantes

Nantes, France

Hôpital européen Georges Pompidou

Paris, France

Hôpital Pitié-Salpétrière

Paris, France

Hôpital Bichat - Claude Bernard

Paris, France

CHU Poitiers

Poitiers, France

Hôpital Pontchaillou

Rennes, France

CHU de Rouen

Rouen, France

Centre Cardiologique du Nord

Saint-Denis, France

CHU Strasbourg

Strasbourg, France

Clinique Pasteur

Toulouse, France

Hôpital Trousseau

Tours, France