RecruitingNCT06580392

CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)

Cardiac Contractility Modulation (CCM) and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure

Sponsor

Impulse Dynamics

Enrollment

200 participants

Start Date

Feb 1, 2025

Study Type

OBSERVATIONAL

Conditions

Heart Failure

Summary

The primary objective of this study is to evaluate the impact of Cardiac Contractility Modulation (CCM) therapy on the initiation and up-titration of Guideline-Directed Medical Therapy (GDMT) in patients with heart failure (HF). This will be assessed by the change in Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month following post-CCM device implant.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether a device called a cardiac contractility modulator (CCM) — which delivers electrical signals to the heart to improve its pumping ability — helps doctors better follow guideline-recommended medication plans for people with heart failure. CCM is implanted like a pacemaker but works differently. **You may be eligible if...** - You are 18 or older with diagnosed heart failure with symptoms - Your heart's pumping function (ejection fraction) is 40% or below - You are already on or being considered for standard heart failure medications **You may NOT be eligible if...** - You have permanent or long-standing atrial fibrillation (a type of irregular heartbeat) - You have had a recent heart attack or heart surgery - You have a device already implanted that would interfere with the CCM Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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