RECRUITING

Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy

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Conditions

Heart Failure with Reduced Ejection FractionImplantable cardioverter defibrillatorSudden cardiac deathguideline directed medical therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients with a Low Risk for Arrhythmic Death

Quick Facts

Study Start:2025-03-04
Study Completion:2031-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06543446

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years (no upper limit)
  2. * 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%
  3. * 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
  4. * 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:
  1. * Existing ICD/CRT-D
  2. * • 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
  3. * Acute MI within the past 3 calendar months
  4. * Chronic renal failure requiring hemodialysis
  5. * Coronary revascularization within the past 3 calendar months
  6. * History of sustained VT or VF
  7. * Known genetic cause of cardiomyopathy
  8. * Life expectancy \< 1 year
  9. * Unable or unwilling to follow study protocol
  10. * Inability to consent

Contacts and Locations

Study Contact

Ilan Goldenberg
CONTACT
585-275-5391
ilan.goldenberg@heart.rochester.edu
Ann Colasurdo
CONTACT
585-275-1054
ann_colasurdo@urmc.rochester.edu

Principal Investigator

Ilan Goldenberg, MD
PRINCIPAL_INVESTIGATOR
Univ of Rochester Medical Center, Clinical Cardiovascular Research Center

Study Locations (Sites)

University of Rochester
Rochester, New York, 14642
United States

Collaborators and Investigators

Sponsor: University of Rochester

  • Ilan Goldenberg, MD, PRINCIPAL_INVESTIGATOR, Univ of Rochester Medical Center, Clinical Cardiovascular Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-04
Study Completion Date2031-02-28

Study Record Updates

Study Start Date2025-03-04
Study Completion Date2031-02-28

Terms related to this study

Keywords Provided by Researchers

  • Implantable cardioverter defibrillator
  • Sudden cardiac death
  • guideline directed medical therapy

Additional Relevant MeSH Terms

  • Heart Failure with Reduced Ejection Fraction