Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

Keywords

Heart Failure With Reduced Ejection Fraction (HFrEF) Dilated Cardiomyopathy heart failure, reduced ejection fraction, cardiomyopathy Heart Failure Cardiomyopathies Cardiomyopathy, Dilated AccuCinch Ventricular Restoration System Guideline-Directed Medical Therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age 18-years or older
  2. Ejection Fraction: ≥20% and ≤40%
  3. LV end-diastolic diameter ≥55 mm
  4. Symptom Status:
  5. NYHA III,
  6. NYHA ambulatory IV, or
  7. NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)
  8. Able to complete six-minute walk test with distance between 100 m and 450 m.
  9. Treatment with guideline-directed medical and device-based therapies for heart failure. Medical treatments should have been established for at least 90 days prior to obtaining consent and doses of medications should be stable for at least 30 days prior to baseline screening, with "stable" defined as no more than 100% increase or 50% decrease of total daily doses. When applicable, device-based therapies should include:
  10. A CRT device, which is required for at least 90 days prior to baseline screening in subjects with left bundle branch block pattern and QRS duration >/=150 ms
  11. An ICD, which is required for all patients in whom it is indicated (based on best local clinical practice) for at least 30 days prior to baseline screening
  12. Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule

You CAN'T join if...

Cardiovascular

  1. Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days.
  2. Untreated clinically significant coronary artery disease (CAD) requiring revascularization
  3. Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
  4. Suboptimal ventricular anatomy or wall thickness as determined from baseline echocardiography and CT scan, with final determination made by the Eligibility Committee
  5. Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy, restrictive cardiomyopathy, uncorrected congenital heart disease, constrictive pericarditis)
  6. Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support
  7. Any planned cardiac surgery or interventions within the next 180 days post-implant (including therapeutic right heart procedures)
  8. Active bacterial endocarditis
  9. Severe RV dysfunction assessed by right heart catheterization (RHC) and TTE
  10. . Fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy
  11. . History of any stroke within the prior 90 days or documented Modified Rankin Scale ≥ 2 disability from any prior stroke

Valvular

  1. . Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)
  2. . Untreated degenerative (primary) mitral valve disease
  3. . Prior mitral or aortic valve replacement
  4. . Severe (≥3+) tricuspid regurgitation
  5. . Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or outflow velocity >300 cm/sec)
  6. . Aortic regurgitation ≥2+

Procedural

  1. . Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch Ventricular Restoration System (e.g., femoral arteries will not support a 20F Introducer sheath)
  2. . Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2)
  3. . Subjects in whom anticoagulation during the procedure is contraindicated
  4. . Subjects in whom 90 days of antiplatelet therapy is contraindicated
  5. . Known allergy to nitinol, polyester, or polyethylene
  6. . Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure

General

  1. . Life expectancy <1 year due to non-cardiac conditions
  2. . Currently participating in another interventional investigational study
  3. . Subjects on high dose steroids or immunosuppressant therapy
  4. . Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • Intermountain Medical Center
    Salt Lake City Utah 84109 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Ancora Heart, Inc.
ID
NCT04331769
Study Type
Interventional
Last Updated