CCM in Heart Failure With Preserved Ejection Fraction (CCM-HFpEF)

Impulse Dynamics

Status: Completed

Conditions: Heart Failure, Diastolic

Treatments: Device: Optimizer SMART

Study type: Interventional

Funder types: Industry

Identifiers

NCT03240237

ID_CP_OPT2016-012_0

Details and patient eligibility

About

This pilot study will evaluate the efficacy and safety of CCM therapy in heart failure patients with baseline EF≥50% (HFpEF) who have New York Heart Association (NYHA) Class II or III symptoms despite appropriate medication.

The terminology of the HF classification HFpEF is based on the 2016 European Society of Cardiology (ESC) Heart Failure Guidelines.

Full description

This is a pilot clinical study of CCM in addition to optimal medical therapy (OMT) over a 24 week period.The primary endpoint shall be mean change from baseline to 24 weeks in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score (reflecting integrated information on physical limitations, symptoms, self-efficacy, social interference and quality of life).

This pilot study will collect efficacy and safety data in heart failure patients having NYHA class II and III symptoms despite appropriate medication with baseline ejection fraction equal or greater than 50% (HFpEF populations).

Enrollment: 47 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion criteria

   1. Baseline ejection fraction ≥ 50% (as assessed by echocardiogram within 30 days of enrollment and confirmed by the echo core laboratory).

   2. NYHA class II or III symptoms despite receiving stable optimal medical therapy (OMT) for at least 30 days based on patient's medical records (chronic stable, not transient or crescendo heart failure or angina pectoris)

   3. Stable optimal medical therapy for Heart failure for 3 months.

   4. NT-proBNP > 220 pg/ml for subjects in sinus rhythm or > 600 pg/ml for subjects in atrial fibrillation

   5. Has the following (as assessed by the core lab):

      • LAVi ≥ 34 ml/m² or LVH >12mm AND either
      • E/e' ≥ 13 OR
      • septal e' < 7 cm/s or lateral e' <10 cm/s

   6. Patient giving informed consent, willing to be available for scheduled study follow-up visits, and able to complete all testing of the study protocol

2. Exclusion criteria

   1. Age below 40 or greater than 80
   2. Patients with expected lifespan of less than 12 months from time of enrollment
   3. Subjects referred to an institution based on a judicial or administrative order
   4. Dilated left ventricle, as evidenced by LVEDVI >= 97 mL/m2 (as assessed by the echo core lab)
   5. Primary cardiac valvular disease (anything more than grade 2)
   6. Congenital or untreated ischemic heart disease
   7. Infiltrative / inflammatory / genetic cardiomyopathy as documented in the medical record (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, M. Fabry, cardiac tumor), or persistent large pericardial effusion
   8. Unstable or frequent (>1 episode/week) angina pectoris
   9. Hospitalization for HF requiring the use of inotropic support or IABP within 30 days of enrollment
   10. Systolic Blood Pressure > 160 mmHg
   11. Uncorrected severe anemia (e.g. hemoglobin <9g/dL)
   12. PR interval greater than 375 ms
   13. Exercise tolerance limited due to noncardiac disorders (e.g. deconditioning, severe lung disease, frailty)
   14. Scheduled for a cardiac surgery or a PCI procedure, or had a cardiac surgery procedure within 90 days or a PCI procedure within 30 days prior to enrollment
   15. Myocardial infarction within 90 days of enrollment
   16. Cardioversion within 30 days of enrollment
   17. History of significant ectopy either on 12-lead ECG or Holter monitoring (more than 10% PVCs).
   18. Heart rate > 110 bpm on ECG for patients with atrial fibrillation
   19. Mechanical tricuspid valve
   20. Prior heart transplant or ventricular assist device
   21. Pregnant or planning to become pregnant during the study
   22. Breastfeeding subjects
   23. Subject participating in another medical therapy or device related study, unrelated to CCM™, at the same time or within 30 days prior to enrollment into this study
   24. Subjects on dialysis, or with documented GFR<30 or with other major medical disorder (e.g. severe anemia, liver failure)
   25. Subjects with any active non-cardiac implants

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

CCM therapy

Experimental group

Description:

Optimizer SMART

Treatment:

Device: Optimizer SMART