RecruitingNot ApplicableNCT05373940

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

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

730 participants

Start Date

Jun 29, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This French study is looking at whether placing a small device called an implantable cardioverter-defibrillator (ICD) — a device that detects and corrects dangerous heart rhythms — can help prevent sudden cardiac death in older adults with weak hearts. **You may be eligible if...** - You are 70 years old or older - Your heart's pumping strength (ejection fraction) is 35% or less - You have moderate to severe heart failure symptoms (NYHA Class II or III) - You have had heart failure for at least 3 months - You are enrolled in the French health insurance system **You may NOT be eligible if...** - You had a heart attack in the past 40 days - You had a heart procedure (catheter or surgery) in the past 90 days - You fainted in the past 6 months - You have advanced brain or cognitive problems - You have another serious illness (like cancer or liver failure) with less than 1 year to live Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEICD 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.

DEVICENo 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

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NCT05373940


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