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

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

Inclusion Criteria:

1. Adults (≥18 years) diagnosed with symptomatic heart failure
2. 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
3. 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 Criteria:

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

Conditions2

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