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

Inclusion Criteria6

Adults (≥18 years) diagnosed with symptomatic heart failure
Patients with Heart failure with reduced Ejection Fraction (HFrEF) where the Ejection Fraction (EF) is ≤40%
\- Historical LVEF assessed up to 6 months prior to consent by any modality can be used if available
Patients can have an active concomitant CRT device already - implanted provided the following criteria:
CRT device has been implanted \>1 year
Patients are functional class NYHA III-IV

Exclusion Criteria8

Patients that are unlikely to adhere to medical therapy for reasons other than intolerance or contraindications.
Patients with a QMS score \>5
eGFR \<15
Patients with a concomitant CRT device that has already been implanted and deemed to be a responder
Patients with class I indication for a concomitant CRT device
Patients with significant comorbidities or conditions that may interfere with the study assessments
Patients with contraindications to CCM therapy or unable to undergo implantation
Severe stenotic valve disease