Actively Recruiting
Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-24
730
Participants Needed
19
Research Sites
413 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 70 years old or older
- Left ventricular ejection fraction 35% or less, assessed by echocardiography, single-photon emission computed tomography, radionuclide ventriculography, or cardiac magnetic resonance within 6 weeks prior to inclusion
- New York Heart Association (NYHA) class II or III
- On heart failure optimal therapy for 3 months or more (exceptions allowed for intolerance or dosage adjustments)
- Provided informed consent
- Affiliated with a French Health Insurance system
You will not qualify if you...
- Enrolled in or planning to enroll in a conflicting interventional trial related to ICD or heart failure therapy
- History of prior unstable sustained ventricular arrhythmia requiring external cardioversion
- Myocardial infarction within the last 40 days
- Coronary artery intervention within the last 90 days
- History of syncope in the previous 6 months
- Advanced cerebrovascular disease affecting autonomy
- Cognitive impairment preventing informed consent
- Any non-cardiac disease with life expectancy less than 1 year (e.g., cancer, uremia, liver failure)
- Under tutorship, curatorship, or legal protection
- Deprived of liberty by judicial or administrative decision (prisoner)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Centre Hospitalier d'Aix en provence
Aix-en-Provence, France, 13616
Actively Recruiting
2
CHU Amiens-Picardie-Site sud
Amiens, France, 80054
Actively Recruiting
3
CHU Brest - Hôpital La Cavale Blanche
Brest, France, 29200
Actively Recruiting
4
HôpitalHenri Mondor
Créteil, France, 94000
Actively Recruiting
5
CHU Grenoble Alpes
La Tronche, France, 38700
Actively Recruiting
6
Groupement d'Hôpitaux de l'Institut Catholique de Lille
Lomme, France, 59462
Actively Recruiting
7
Hôpital de La Timone
Marseille, France, 13385
Actively Recruiting
8
Hôpital de Brabois
Nancy, France, 54710
Actively Recruiting
9
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
10
Hôpital européen Georges Pompidou
Paris, France, , 75015
Actively Recruiting
11
Hôpital Pitié-Salpétrière
Paris, France, 75013
Actively Recruiting
12
Hôpital Bichat - Claude Bernard
Paris, France, 75014
Actively Recruiting
13
CHU Poitiers
Poitiers, France, 86021
Actively Recruiting
14
Hôpital Pontchaillou
Rennes, France, 35033
Actively Recruiting
15
CHU de Rouen
Rouen, France, 76000
Actively Recruiting
16
Centre Cardiologique du Nord
Saint-Denis, France, 93207
Actively Recruiting
17
CHU Strasbourg
Strasbourg, France, 67200
Actively Recruiting
18
Clinique Pasteur
Toulouse, France, 31076
Actively Recruiting
19
Hôpital Trousseau
Tours, France, 37170
Actively Recruiting
Research Team
A
Alexandra BRUNEAU, Mrs
CONTACT
E
Eloi MARIJON, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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