Evaluating Cardiac Contractility Modulation Therapy in Heart Failure Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effects of Cardiac Contractility Modulation (CCM) therapy on the initiation and adjustment of Guideline-Directed Medical Therapy (GDMT) in patients suffering from heart failure. It involves a prospective, non-randomized analysis of medication use and dosing before and after the CCM therapy. A total of 100 subjects will be enrolled, and their Quad Medication Score (QMS) will be evaluated at baseline and again at 6 and 12 months following the CCM device implant to determine the therapy's impact on medication optimization.

Why it matters

Who can join: the full rules

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

Where it's running

• Gemelli University Hospital
  Rome, Italy, Italy Recruiting
• AO dei Colli - O.Monaldi
  Naples, Italy Recruiting

Study contacts

• Study coordinator: Gary Cranke
• Email: gcranke@impulsedynamics.com
• Phone: (856) 642-9933

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.