Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy

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).

Conditions

Heart Failure with Reduced Ejection Fraction

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

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

Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy

Condition
Heart Failure with Reduced Ejection Fraction
Intervention / Treatment

-

Contacts and Locations

Rochester

University of Rochester, Rochester, New York, United States, 14642

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Rochester,

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

Study Record Dates

2031-02-28