Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy (CONTEMP-ICD)

University of Rochester

Status

Not yet enrolling

Conditions

Heart Failure With Reduced Ejection Fraction

Treatments

Procedure: ICD implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT06543446

ADVARRA

Details and patient eligibility

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

3,290 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years (no upper limit)
Class I or IIa indication for a primary prevention ICD15: Ischemic or non-ischemic cardiomyopathy and NYHA Class ≥ II if most recent LVEF is ≤ 35% OR ischemic cardiomyopathy with NYHA Class I if most recent LVEF is ≤ 30%
Most recent LVEF (%) obtained per cardiac imaging obtained at any time prior to enrollment after being stable on optimal GDMT for at least one month
Stable optimal GDMT at least one calendar month prior to last cardiac imaging test, prespecified as one of the following for at least 1 calendar month prior to study randomization:

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

Existing ICD/CRT-D
Planned CRT-P or CRT-D implant for any indications including Class I or IIa indication for CRT: Presence of left bundle branch block (LBBB) with QRS ≥ 120 msec OR QRS duration ≥ 150 msec regardless of QRS morphology OR decision for CRT implant by EP provider for other indications
Acute MI within the past 3 calendar months
Chronic renal failure requiring hemodialysis
Coronary revascularization within the past 3 calendar months