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Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
Sponsor: Assistance Publique - Hôpitaux de Paris
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
Conditions
Interventions
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.
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