Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy

Launched by UNIVERSITY OF ROCHESTER · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a device called an implantable cardioverter defibrillator (ICD) compared to non-device therapies in patients with heart failure and reduced heart function. The goal is to see if having an ICD can lower the risk of death for people with this condition. Researchers are currently looking for participants aged 18 and older who meet specific health criteria, such as having a recent heart function measurement (known as ejection fraction) that shows significant heart weakness and being stable on heart failure medications for at least a month.

If you or a loved one is eligible and decides to participate, you will be randomly assigned to either receive an ICD or continue with non-device treatment. Throughout the trial, participants will be closely monitored to assess their health and any changes in their heart condition. It’s important to note that certain individuals, such as those who already have an ICD or those with specific heart issues, may not be eligible to join. This trial aims to provide valuable information that could help improve treatment options for heart failure in the future.

Gender

ALL

Eligibility criteria

• 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 (per Figure 7)
• • • MADIT-ICD Benefit Score \< 50 (per Figure 4)
• 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
• • 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