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

Recruiting N/A Interventional Study
Heart Failure Primary Prevention of Sudden Cardiac Death Implantable Cardioverter Defibrillator
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
70 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
730 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * ≥70 years old, * Left ventricular ejection fraction ≤ 35%, assessed by echocardiography, single-photon emission computed tomography and radionuclide ventriculography and/or cardiac magnetic resonance (CMR) (assessed at inclusion or within the 6 weeks prior to inclusion). * NYH…
Contacts

Alexandra BRUNEAU, Mrs

+33144841712

alexandra.bruneau@aphp.fr

CONTACT

Eloi MARIJON, MD, PhD

+33156093692

eloi.marijon@aphp.fr

CONTACT