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
- Conditions
- Heart Failure with Reduced Ejection Fraction (HFrEF)Dilated Cardiomyopathy
- Interventions
- Device: AccuCinch Ventricular Restoration SystemDrug: Guideline-Directed Medical Therapy
- Registration Number
- NCT04331769
- Lead Sponsor
- Ancora Heart, Inc.
- Brief Summary
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).
- Detailed Description
The CORCINCH-HF Study is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch Ventricular Restoration System.
Subjects will be randomized in a 1:1 ratio:
1. Treatment group: AccuCinch Ventricular Restoration System plus guideline-directed medical therapy (GDMT) (n\~200)
2. Control group: Guideline-directed medical therapy (GDMT) (n\~200)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
-
Age 18-years or older
-
Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab
-
LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab
-
Symptom Status:
- NYHA III,
- NYHA ambulatory IV, or
- NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)
-
Able to complete six-minute walk test with distance between 100 m and 450 m.
-
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.
- "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
- 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
- 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)
- When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments
- 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
- 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
- If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments
- 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)
- 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
-
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
Cardiovascular
-
Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
-
Untreated clinically significant coronary artery disease (CAD) requiring revascularization
-
Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
-
Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan
-
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)
-
Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support
-
Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures)
-
Active bacterial endocarditis
-
Severe RV dysfunction assessed by right heart catheterization (RHC) and/or TTE
-
Fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy
-
History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale ≥ 2 disability from any prior stroke
Valvular
-
Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)
-
Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable)
-
Prior mitral or aortic valve replacement
-
Tricuspid regurgitation grade 4+ (severe)
-
Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax >300 cm/sec)
-
Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe)
Procedural
-
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)
-
Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2)
-
Subjects in whom anticoagulation during the procedure is contraindicated
-
Subjects in whom 90 days of antiplatelet therapy is contraindicated
-
Known allergy to nitinol, polyester, or polyethylene
-
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
-
Life expectancy <1 year due to non-cardiac conditions
-
Currently participating in another interventional investigational study
-
Subjects on high dose steroids or immunosuppressant therapy
-
Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Device group: AccuCinch Ventricular Restoration System AccuCinch Ventricular Restoration System Subjects in this arm will receive the AccuCinch Ventricular Restoration System Control group: Guideline-Directed Medical Therapy Guideline-Directed Medical Therapy Subjects in this arm will receive guideline-directed medical therapy (GDMT)
- Primary Outcome Measures
Name Time Method Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score 180 days Higher scores in the KCCQ reflect better health status
A hierarchical composite endpoint of all-cause deaths, left ventricular assist device (LVAD) implants or heart transplants, heart failure hospitalizations, and changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) 365 days A hierarchical composite endpoint of number of all-cause deaths, number of left ventricular assist device (LVAD) implants or heart transplants, number of heart failure hospitalizations, and change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS), evaluated using the Win Ratio method
Freedom from device- or femoral artery access-related major adverse events (MAE) 365 days MAE defined as:
1. All-cause death,
2. Myocardial infarction,
3. Stroke,
4. Need for non-elective cardiovascular surgery,
5. Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours
6. Acute kidney injury requiring renal replacement therapy6-Minute Walk Test (6MWT) distance (m) 180 days Change in 6MWT distance (m) from baseline
- Secondary Outcome Measures
Name Time Method Number of all-cause deaths 30 days, 90 days, 180 days, 365 days, 545 days, 730 days Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT 180 days Number of all-cause hospitalizations 30 days, 90 days, 180 days, 365 days, 545 days, 730 days Incidence of all serious adverse events, including device- and procedure- related complications 30 days, 90 days, 180 days, 365 days, 545 days, 730 days Changes from baseline in 6-Minute Walk Test (6MWT) 30 days, 90 days, 365 days, 545 days, 730 days Measure in meters
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo 30 days, 90 days, 365 days, 730 days Number of all-cause deaths or all-cause hospitalizations 30 days, 90 days, 180 days, 365 days, 545 days, 730 days Changes from baseline in New York Heart Association (NYHA) functional class 30 days, 90 days, 180 days, 365 days, 545 days, 730 days Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) 30 days, 90 days, 365 days, 545 days, 730 days Higher scores in the KCCQ reflect better health status
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT 180 days Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo 30 days, 90 days, 365 days, 730 days Rate and number of cardiovascular death events 30 days, 90 days, 180 days, 365 days, 545 days, 730 days Rate and number of heart failure-related hospitalizations 30 days, 90 days, 180 days, 365 days, 545 days, 730 days Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo 30 days, 90 days, 365 days, 730 days Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT 180 days Rate and number of heart failure death events 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Trial Locations
- Locations (128)
Dignity Health St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, United States
Immanuel Klinikum Bernau Herzzentrum Brandenburg Universitätsklinikum der Medizinischen Hochschule Brandenburg
🇩🇪Bernau, Germany
CardioVasculäres Centrum
🇩🇪Frankfurt, Germany
Universitätsklinikum Halle (Saale)
🇩🇪Halle, Germany
Universitäres Herz- und Gefäßzentrum Hamburg
🇩🇪Hamburg, Germany
Universitätsklinikum Köln (AöR)
🇩🇪Köln, Germany
IRCCS Istituto Clinico Humanitas
🇮🇹Milano, Lombardy, Italy
Grandview Medical Group Research, LLC
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Phoenix Cardiovascular Research Group
🇺🇸Phoenix, Arizona, United States
Tucson Medical Center
🇺🇸Tucson, Arizona, United States
Baptist Health Heart Failure & Transplant Institute
🇺🇸Little Rock, Arkansas, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Scripps Health
🇺🇸La Jolla, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Kaiser Permanente San Francisco
🇺🇸San Francisco, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Hartford Health
🇺🇸Hartford, Connecticut, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Medstar Health Research Institute
🇺🇸Washington, District of Columbia, United States
JFK Medical Center
🇺🇸Atlantis, Florida, United States
HCA Florida Largo Hospital
🇺🇸Largo, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Ascension Sacred Heart
🇺🇸Pensacola, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Advocate Good Samaritan Hospital
🇺🇸Downers Grove, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Cardiovascular Research Institute of Kansas
🇺🇸Wichita, Kansas, United States
Norton Heart Specialists
🇺🇸Louisville, Kentucky, United States
Our Lady of the Lake Regional Medical Center
🇺🇸Baton Rouge, Louisiana, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
Northern Light Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Ascension Providence Hospital
🇺🇸Southfield, Michigan, United States
Metropolitan Heart and Vascular Institute & Mercy Hosp
🇺🇸Coon Rapids, Minnesota, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
Washington University in St. Louis
🇺🇸St. Louis, Missouri, United States
Deborah Heart & Lung
🇺🇸Browns Mills, New Jersey, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
New Mexico Heart Institute
🇺🇸Albuquerque, New Mexico, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
University at Buffalo
🇺🇸Buffalo, New York, United States
Northwell Health
🇺🇸Manhasset, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
CUMC/New York Presbyterian Hospital
🇺🇸New York, New York, United States
Weill Cornell Medicine-New York Presbyterian Hospital
🇺🇸New York, New York, United States
Vassar Brothers Medical Center
🇺🇸Poughkeepsie, New York, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
NC Heart and Vascular Research, LLC
🇺🇸Raleigh, North Carolina, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
UH Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
INTEGRIS Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Geisinger Clinic
🇺🇸Danville, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
🇺🇸Harrisburg, Pennsylvania, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Heart and Vascular Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Prisma Health
🇺🇸Columbia, South Carolina, United States
Tennova Healthcare-Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
Ascension Saint Thomas
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Ascension Texas Cardiovascular
🇺🇸Austin, Texas, United States
Austin Heart
🇺🇸Austin, Texas, United States
Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States
Houston Heart
🇺🇸Houston, Texas, United States
Baylor College of Medicine St. Luke's Medical Center
🇺🇸Houston, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
UT Health
🇺🇸Houston, Texas, United States
Texas Tech University Health Sciences Center
🇺🇸Lubbock, Texas, United States
Baylor Scott & White
🇺🇸Plano, Texas, United States
Methodist Healthcare System, San Antonio
🇺🇸San Antonio, Texas, United States
Intermountain Medical Center
🇺🇸Salt Lake City, Utah, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
CJW Chippenham Medical Center
🇺🇸Richmond, Virginia, United States
Bon Secours St Mary's Hospital
🇺🇸Richmond, Virginia, United States
Carilion Roanoke Memorial Hospital
🇺🇸Roanoke, Virginia, United States
Valley Health Winchester
🇺🇸Winchester, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
Providence Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Republican Scientific and Practical Centre of Cardiology
🇧🇾Minsk, Belarus
OLV Heart Centre
🇧🇪Aalst, Belgium
AZ Sint-Jan-Oostende AV Campus Brugge
🇧🇪Brugge, Belgium
St. Anne's University Hospital
🇨🇿Brno, Czechia
Na Homolce Hospital
🇨🇿Prague, Czechia
Hôpital de la Timone
🇫🇷Marseille, France
CHU de Rennes - Hôpital Pontchaillou
🇫🇷Rennes, France
Clinique-Pasteur
🇫🇷Toulouse, France
Hygeia Hospital
🇬🇷Athens, Greece
Onassis Cardiac Surgery Center
🇬🇷Kallithéa, Greece
Interbalkan Medical Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Centro Cardiologico Monzino S.p.a
🇮🇹Milano, Italy
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Institute of Cardiovascular Diseases of Vojvodina
🇷🇸Belgrade, Serbia
Institute of Cardiovascular Diseases
🇷🇸Belgrade, Serbia
University Clinical Centre of Serbia
🇷🇸Belgrade, Serbia
University Clinical Center Niš
🇷🇸Niš, Serbia