ICD for Heart Failure
(CONTEMP-ICD Trial)

Recruiting in Palo Alto (17 mi)

Overseen byIlan Goldenberg, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Rochester

No Placebo Group

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for adults with heart failure who are on a comprehensive treatment plan including beta-blockers and other specific medications, or have a high enough score on the GDMT scale. They must also meet certain criteria based on their heart function (LVEF percentage) and symptoms. People with less severe conditions or those not meeting the medication requirements cannot participate.

Inclusion Criteria

I am on four specific heart failure medications or my treatment score is 6 or higher.

My MADIT-ICD Benefit Score is below 50.

I am 18 years old or older.

+2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either ICD implantation or no ICD implantation and receive guideline-directed medical therapy

3.5 years

Visits at initial, 3 months, 6 months, and every 6 months thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment, including all-cause mortality and major adverse cardiovascular events

3.5 years

Participant Groups

The study aims to compare two approaches in patients with reduced heart function due to heart failure: one group will receive an implantable cardioverter defibrillator (ICD), while the other will not. The main goal is to see if there's a difference in survival rates between the two groups.

2Treatment groups

Active Control

Group I: No-ICD implantationActive Control1 Intervention

No-ICD implantation despite current recommendation

Group II: ICD implantationActive Control1 Intervention

ICD implantation based on current guidelines