Status:
RECRUITING
Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Heart Failure
Primary Prevention of Sudden Cardiac Death
Eligibility:
All Genders
70+ years
Phase:
NA
Brief 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 ...
Detailed Description
Rationale Although not recognized by guidelines, there is no available data demonstrating the benefit of Implantable Cardioverter Defibrillator (ICD) for primary prevention strategy of Sudden Cardiac ...
Eligibility Criteria
Inclusion
- ≥70 years old,
- Left ventricular ejection fraction ≤ 35%
- NYHA class II or III
- Heart failure HFOT ≥ 3 months
- Providing informed consent
- Affiliated to a French Health Insurance system.
Exclusion
- Enrolled in or planning to enroll in a conflicting interventional trial
- Prior unstable sustained ventricular arrhythmia requiring external cardioversion
- Myocardial infarction within the 40 days
- Coronary artery intervention (catheter or surgical) within 90 days
- History of syncope in the previous 6 months
- Advanced cerebrovascular disease
- Cognitive impairment leading to the incapacity of consent
- Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.
- Patient under tutorship, curatorship, or legal safeguard
- Persons deprived of their liberty by judicial or administrative decision (prisoner)
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2030
Estimated Enrollment :
730 Patients enrolled
Trial Details
Trial ID
NCT05373940
Start Date
June 29 2022
End Date
May 31 2030
Last Update
November 27 2024
Active Locations (19)
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1
Centre Hospitalier d'Aix en provence
Aix-en-Provence, France, 13616
2
CHU Amiens-Picardie-Site sud
Amiens, France, 80054
3
HôpitalHenri Mondor
Créteil, France, 94000
4
CHU Grenoble Alpes
La Tronche, France, 38700