RECRUITING

Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF): the CORCINCH-HF Study

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Conditions

Heart Failure with Reduced Ejection Fraction (HFrEF)Dilated CardiomyopathyHeart FailureReduced Ejection FractionCardiomyopathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF): the CORCINCH-HF Study

Quick Facts

Study Start:2020-12-21
Study Completion:2030-12-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04331769

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18-years or older
  2. 2. Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab
  3. 3. LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab
  4. 4. Symptom Status:
  5. 1. NYHA III,
  6. 2. NYHA ambulatory IV, or
  7. 3. NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)
  8. 5. Able to complete six-minute walk test with distance between 100 m and 450 m.
  9. 6. Diagnosis and treatment for heart failure should be established at least 90 days before the date of consent. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current guidelines as standard-of-care for Heart Failure therapy, with any intolerance documented.
  10. 1. "Stable" is defined as no more than a 100% increase or a 50% decrease of total daily doses. Medication changes within this range do not require any additional waiting before the screening assessments
  11. 2. When a total daily dose increase or decrease exceeds that which is considered stable, the screening TTE and CT will be postponed 30 days after the medication change
  12. 3. When additional titration is required to optimize a subject's medication that exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the optimal dose remains outside of the stable parameters)
  13. 4. When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments
  14. 5. When a change in class medication change exceeds what is considered stable, OR a new class of medication is added, the screening TTE and CT will be postponed 30 days after the medication change
  15. 6. If an SGLT2 inhibitor is added to a subject's medications, the screening TTE and CT will be postponed at least 30 days after the addition
  16. 7. If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments
  17. 8. If an SGLT2 inhibitor dose change exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the dose remains outside of the stable parameters)
  18. 9. When applicable, for guideline-directed device-based therapies: a CRT device must be placed \> 90 days before the screening TTE and CT, and an ICD must be placed \> 30 days before the screening TTE and CT
  19. 7. Able and willing to complete all qualifying diagnostic and functional tests, willing to accept blood product transfusion if required and agrees to comply with study follow-up schedule
  1. 1. Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
  2. 2. Untreated clinically significant coronary artery disease (CAD) requiring revascularization
  3. 3. Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
  4. 4. Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan
  5. 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. 6. Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support
  7. 7. Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures)
  8. 8. Active bacterial endocarditis
  9. 9. Severe RV dysfunction assessed by right heart catheterization (RHC) and/or TTE
  10. 10. Fixed pulmonary hypertension with PA systolic pressure \>70 mmHg not responsive to vasodilator therapy
  11. 11. History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale ≥ 2 disability from any prior stroke
  12. 12. Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)
  13. 13. Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable)
  14. 14. Prior mitral or aortic valve replacement
  15. 15. Tricuspid regurgitation grade 4+ (severe)
  16. 16. Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax \>300 cm/sec)
  17. 17. Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe)
  18. 18. 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)
  19. 19. Renal insufficiency (i.e., eGFR of \<25 ml/min/1.73 m2)
  20. 20. Subjects in whom anticoagulation during the procedure is contraindicated
  21. 21. Subjects in whom 90 days of antiplatelet therapy is contraindicated
  22. 22. Known allergy to nitinol, polyester, or polyethylene
  23. 23. 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
  24. 24. Life expectancy \<1 year due to non-cardiac conditions
  25. 25. Currently participating in another interventional investigational study
  26. 26. Subjects on high dose steroids or immunosuppressant therapy
  27. 27. Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating

Contacts and Locations

Study Contact

Michael Zapien, MS, CCRA
CONTACT
408-727-1105
mzapien@ancoraheart.com

Principal Investigator

Martin B Leon, MD
STUDY_CHAIR
Columbia University
Ulrich P Jorde, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center/Albert Einstein College of Medicine
Mark Reisman, MD
PRINCIPAL_INVESTIGATOR
New York Presbyterian/Weill Cornell Medicine

Study Locations (Sites)

Grandview Medical Group Research, LLC
Birmingham, Alabama, 35243
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85016
United States
Tucson Medical Center
Tucson, Arizona, 85712
United States
Baptist Health Heart Failure & Transplant Institute
Little Rock, Arkansas, 72205
United States
University of California San Diego
La Jolla, California, 92037
United States
Scripps Health
La Jolla, California, 92121
United States
University of Southern California
Los Angeles, California, 90033
United States
Kaiser Permanente San Francisco
San Francisco, California, 94115
United States
University of California, San Francisco
San Francisco, California, 94143
United States
University of Colorado
Aurora, Colorado, 80045
United States
Hartford Health
Hartford, Connecticut, 06102
United States
Yale University
New Haven, Connecticut, 06519
United States
Medstar Health Research Institute
Washington, District of Columbia, 20010
United States
JFK Medical Center
Atlantis, Florida, 33462
United States
HCA Florida Largo Hospital
Largo, Florida, 33770
United States
University of Miami
Miami, Florida, 33136
United States
Ascension Sacred Heart
Pensacola, Florida, 32504
United States
University of South Florida
Tampa, Florida, 33606
United States
Emory University
Atlanta, Georgia, 30308
United States
Piedmont Heart Institute
Atlanta, Georgia, 30309
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
United States
Norton Heart Specialists
Louisville, Kentucky, 40216
United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360
United States
Northern Light Eastern Maine Medical Center
Bangor, Maine, 04401
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Massachusetts
Worcester, Massachusetts, 01655
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Spectrum Health
Grand Rapids, Michigan, 49503
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
Ascension Providence Hospital
Southfield, Michigan, 48075
United States
Metropolitan Heart and Vascular Institute & Mercy Hosp
Coon Rapids, Minnesota, 55433
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
United States
University of Minnesota
Minneapolis, Minnesota, 55414
United States
Jackson Heart Clinic
Jackson, Mississippi, 39216
United States
Washington University in St. Louis
St. Louis, Missouri, 63110
United States
Deborah Heart & Lung
Browns Mills, New Jersey, 08015
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
University at Buffalo
Buffalo, New York, 14203
United States
Northwell Health
Manhasset, New York, 11030
United States
NYU Langone Health
New York, New York, 10016
United States
Mount Sinai Hospital
New York, New York, 10029
United States
CUMC/New York Presbyterian Hospital
New York, New York, 10032
United States
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, 10065
United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
United States
St. Francis Hospital
Roslyn, New York, 11576
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, 27607
United States
The Christ Hospital
Cincinnati, Ohio, 45219
United States
UH Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Ohio State University
Columbus, Ohio, 43210
United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Geisinger Clinic
Danville, Pennsylvania, 17822
United States
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17101
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania, 15232
United States
Rhode Island Hospital
Providence, Rhode Island, 02904
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Prisma Health
Columbia, South Carolina, 29203
United States
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, 37934
United States
Ascension Saint Thomas
Nashville, Tennessee, 37221
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 87232
United States
Ascension Texas Cardiovascular
Austin, Texas, 78705
United States
Austin Heart
Austin, Texas, 78756
United States
Baylor Scott & White Research Institute
Dallas, Texas, 75226
United States
Houston Heart
Houston, Texas, 77004
United States
Baylor College of Medicine St. Luke's Medical Center
Houston, Texas, 77020
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
UT Health
Houston, Texas, 77030
United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
United States
Baylor Scott & White
Plano, Texas, 75093
United States
Methodist Healthcare System, San Antonio
San Antonio, Texas, 78229
United States
Intermountain Medical Center
Salt Lake City, Utah, 84109
United States
University of Virginia Health System
Charlottesville, Virginia, 22908
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States
CJW Chippenham Medical Center
Richmond, Virginia, 23225
United States
Bon Secours St Mary's Hospital
Richmond, Virginia, 23226
United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
United States
Valley Health Winchester
Winchester, Virginia, 22601
United States
University of Washington
Seattle, Washington, 98195
United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
United States
Charleston Area Medical Center
Charleston, West Virginia, 25304
United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, 85013
United States

Collaborators and Investigators

Sponsor: Ancora Heart, Inc.

  • Martin B Leon, MD, STUDY_CHAIR, Columbia University
  • Ulrich P Jorde, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center/Albert Einstein College of Medicine
  • Mark Reisman, MD, PRINCIPAL_INVESTIGATOR, New York Presbyterian/Weill Cornell Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-21
Study Completion Date2030-12-21

Study Record Updates

Study Start Date2020-12-21
Study Completion Date2030-12-21

Terms related to this study

Keywords Provided by Researchers

  • Heart Failure
  • Reduced Ejection Fraction
  • Cardiomyopathy

Additional Relevant MeSH Terms

  • Heart Failure with Reduced Ejection Fraction (HFrEF)
  • Dilated Cardiomyopathy