Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy
NCT ID: NCT06543446
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3290 participants
INTERVENTIONAL
2025-03-04
2031-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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No-ICD implantation
No-ICD implantation despite current recommendation
No interventions assigned to this group
ICD implantation
ICD implantation based on current guidelines
ICD implantation
Surgical implant of ICD device
Interventions
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ICD implantation
Surgical implant of ICD device
Eligibility Criteria
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Inclusion Criteria
* 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 (per Figure 7)
• MADIT-ICD Benefit Score \< 50 (per Figure 4)
Exclusion Criteria
* • 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
* History of sustained VT or VF
* Known genetic cause of cardiomyopathy
* Life expectancy \< 1 year
* Unable or unwilling to follow study protocol
* Inability to consent
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Rochester
OTHER
Responsible Party
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Ilan Goldenberg
Professor of Medicine
Principal Investigators
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Ilan Goldenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Univ of Rochester Medical Center, Clinical Cardiovascular Research Center
Locations
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MaineHealth
Portland, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Corewell Health
Grand Rapids, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Rutgers
New Brunswick, New Jersey, United States
The Valley Hospital
Paramus, New Jersey, United States
Northwell Health
New York, New York, United States
Nuvance Health Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, New York, United States
University of Rochester
Rochester, New York, United States
Intermountain Health Care, Inc.
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Fiuzat M, Hamo CE, Butler J, Abraham WT, DeFilippis EM, Fonarow GC, Lindenfeld J, Mentz RJ, Psotka MA, Solomon SD, Teerlink JR, Vaduganathan M, Vardeny O, McMurray JJV, O'Connor CM. Optimal Background Pharmacological Therapy for Heart Failure Patients in Clinical Trials: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 Feb 8;79(5):504-510. doi: 10.1016/j.jacc.2021.11.033.
Goldenberg I, Zareba W, Ezekowitz JA, Albert C, Alexis JD, Anderson L, Behr ER, Daubert J, Di Palo KE, Ellenbogen KA, Dzikowicz DJ, Harrington JM, Hsich E, Huang DT, Januzzi JL, Jawaid A, Kutyifa V, Lala-Trindade A, Nakonechnyi A, Onwuanyi A, Pina IL, Sandhu RK, Sears S, Sroubek J, Baykaner T, Strawderman R, Beck C, Butler J. Rationale and design of the comparative effectiveness of ICD vs non-ICD therapy in contemporary heart failure patients at a low risk for arrhythmic death (CONTEMP-ICD) trial. Am Heart J. 2026 Jan;291:162-174. doi: 10.1016/j.ahj.2025.08.020. Epub 2025 Sep 4.
Other Identifiers
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ADVARRA
Identifier Type: -
Identifier Source: org_study_id
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