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

I

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)

47 participants in 1 patient group

CCM therapy
Experimental group
Description:
Optimizer SMART
Treatment:
Device: Optimizer SMART

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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