Status
Conditions
Treatments
About
The investigators aim to compare the risk of mortality of Non-implantable carioverter defibrillator (ICD) vs. ICD management in patients with heart failure with reduced ejection fraction (HFrEF).
Full description
The proposed CONTEMP-ICD trial is a prospective, multicenter, open-label, randomized controlled trial; enrolling 3290 participants with HFrEF, on stable and optimal guideline-directed medical therapy (GDMT), who are eligible for a primary prevention ICD, but have a low predicted arrhythmic risk. Enrolled participants will be randomized in a 1:1 ratio to non-ICD vs. ICD treatment arms. The investigators hypothesize that, in participants with HFrEF who have a low predicted arrhythmic risk, non-ICD vs. ICD is non-inferior with respect to the primary endpoint of all-cause mortality and superior survival free of major cardiovascular (CV) events.
This study will recruit adults 18 years of age and older with heart failure. Participants will be asked to complete questionnaires. Information from medical records will be gathered including medical history, physical exam, medications, blood work results, and imaging. Visits will be at initial, three, six months, and every six months beyond six months. For those who get an ICD device an interrogation will be collected at the visits.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
receiving all 4 therapy classes (beta-blockers, ARNI/ARB/ACE, MRA and SGLT2i) OR GDMT Score ≥ 6 (Reference: 45. Yoruk A, Huang DT, Hall BW, Rosero S, Sherazi S, Chen L, Kutyifa V, H. Massey T, Aktas MK. Intraoperative ventricular tachycardia ablation during left ventricular assist device implant in patients with medically refractory ventricular tachycardia. American Heart Association Scientific Sessions 2016. Circulation. 2016;134:A17366.)
MADIT-ICD Benefit Score < 50 (Reference: Snipelisky D, Reddy YN, Manocha K, Patel A, Dunlay SM, Friedman PA, Munger TM, Asirvatham SJ, Packer DL, Cha YM, Kapa S, Brady PA, Noseworthy PA, Maleszewski JJ, Mulpuru SK. Effect of ventricular arrhythmia ablation in patients with Heart Mate II left ventricular assist devices: an evaluation of ablation therapy. J Cardiovasc Electrophysiol. 2017;28:68-77)
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
3,290 participants in 2 patient groups
Loading...
Central trial contact
Ilan Goldenberg; Ann Colasurdo
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal