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

Status: Recruiting
Location: See all (129) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Grandview Medical Group Research, LLC
TERMINATED
Birmingham
University of Alabama at Birmingham
WITHDRAWN
Birmingham
Arkansas
Baptist Health Heart Failure & Transplant Institute
WITHDRAWN
Little Rock
Arizona
Dignity Health St. Joseph's Hospital and Medical Center
RECRUITING
Phoenix
Phoenix Cardiovascular Research Group
RECRUITING
Phoenix
Tucson Medical Center
RECRUITING
Tucson
California
Scripps Health
RECRUITING
La Jolla
University of California San Diego
RECRUITING
La Jolla
University of Southern California
RECRUITING
Los Angeles
Kaiser Permanente San Francisco
COMPLETED
San Francisco
University of California, San Francisco
RECRUITING
San Francisco
Colorado
University of Colorado
WITHDRAWN
Aurora
Connecticut
Hartford Health
RECRUITING
Hartford
Yale University
RECRUITING
New Haven
Washington, D.c.
Medstar Health Research Institute
RECRUITING
Washington D.c.
Florida
JFK Medical Center
TERMINATED
Atlantis
HCA Florida Largo Hospital
RECRUITING
Largo
University of Miami
RECRUITING
Miami
Ascension Sacred Heart
RECRUITING
Pensacola
University of South Florida
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Northside Hospital
RECRUITING
Atlanta
Piedmont Heart Institute
WITHDRAWN
Atlanta
Illinois
Northwestern University
WITHDRAWN
Chicago
University of Chicago Medical Center
RECRUITING
Chicago
Advocate Good Samaritan Hospital
RECRUITING
Downers Grove
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Cardiovascular Research Institute of Kansas
RECRUITING
Wichita
Kentucky
University of Kentucky
RECRUITING
Lexington
University of Kentucky
RECRUITING
Lexington
Norton Heart Specialists
RECRUITING
Louisville
Louisiana
Our Lady of the Lake Regional Medical Center
RECRUITING
Baton Rouge
Cardiovascular Institute of the South
RECRUITING
Houma
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
University of Massachusetts
RECRUITING
Worcester
Maryland
University of Maryland Medical Center
RECRUITING
Baltimore
Maine
Northern Light Eastern Maine Medical Center
RECRUITING
Bangor
Michigan
University of Michigan
RECRUITING
Ann Arbor
Spectrum Health
RECRUITING
Grand Rapids
William Beaumont Hospital
COMPLETED
Royal Oak
Ascension Providence Hospital
RECRUITING
Southfield
Minnesota
Metropolitan Heart and Vascular Institute & Mercy Hosp
RECRUITING
Coon Rapids
Minneapolis Heart Institute Foundation
RECRUITING
Minneapolis
University of Minnesota
RECRUITING
Minneapolis
Missouri
Washington University in St. Louis
RECRUITING
St Louis
Mississippi
Jackson Heart Clinic
RECRUITING
Jackson
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
NC Heart and Vascular Research, LLC
RECRUITING
Raleigh
New Jersey
Deborah Heart & Lung
RECRUITING
Browns Mills
Hackensack University Medical Center
RECRUITING
Hackensack
Morristown Medical Center
WITHDRAWN
Morristown
Rutgers Robert Wood Johnson Medical School
RECRUITING
New Brunswick
New Mexico
New Mexico Heart Institute
RECRUITING
Albuquerque
New York
University at Buffalo
RECRUITING
Buffalo
Northwell Health
RECRUITING
Manhasset
CUMC/New York Presbyterian Hospital
RECRUITING
New York
Mount Sinai Hospital
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Weill Cornell Medicine-New York Presbyterian Hospital
RECRUITING
New York
Vassar Brothers Medical Center
COMPLETED
Poughkeepsie
St. Francis Hospital
RECRUITING
Roslyn
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
The Christ Hospital
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
UH Cleveland Medical Center
WITHDRAWN
Cleveland
Ohio State University
RECRUITING
Columbus
Oklahoma
INTEGRIS Baptist Medical Center
RECRUITING
Oklahoma City
Oklahoma Heart Hospital
RECRUITING
Oklahoma City
Oklahoma Heart Institute
RECRUITING
Tulsa
Oregon
Oregon Health & Science University
RECRUITING
Portland
Providence St. Vincent Medical Center
RECRUITING
Portland
Pennsylvania
Geisinger Clinic
RECRUITING
Danville
Pinnacle Health Cardiovascular Institute
WITHDRAWN
Harrisburg
Penn State Hershey Medical Center
RECRUITING
Hershey
Thomas Jefferson University
COMPLETED
Philadelphia
Allegheny General Hospital
RECRUITING
Pittsburgh
UPMC Heart and Vascular Institute
RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Prisma Health
RECRUITING
Columbia
Tennessee
Tennova Healthcare-Turkey Creek Medical Center
RECRUITING
Knoxville
Ascension Saint Thomas
RECRUITING
Nashville
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Ascension Texas Cardiovascular
RECRUITING
Austin
Austin Heart
COMPLETED
Austin
Baylor Scott & White Research Institute
RECRUITING
Dallas
Baylor College of Medicine St. Luke's Medical Center
RECRUITING
Houston
Houston Heart
RECRUITING
Houston
Houston Methodist Hospital
NOT_YET_RECRUITING
Houston
UT Health
RECRUITING
Houston
Texas Tech University Health Sciences Center
RECRUITING
Lubbock
Baylor Scott & White
COMPLETED
Plano
Methodist Healthcare System, San Antonio
RECRUITING
San Antonio
Utah
Intermountain Medical Center
RECRUITING
Salt Lake City
Virginia
University of Virginia Health System
RECRUITING
Charlottesville
Sentara Norfolk General Hospital
TERMINATED
Norfolk
Bon Secours St Mary's Hospital
RECRUITING
Richmond
CJW Chippenham Medical Center
TERMINATED
Richmond
Carilion Roanoke Memorial Hospital
RECRUITING
Roanoke
Valley Health Winchester
RECRUITING
Winchester
Washington
University of Washington
RECRUITING
Seattle
Providence Sacred Heart Medical Center
RECRUITING
Spokane
Wisconsin
Aurora St. Luke's Medical Center
RECRUITING
Milwaukee
Medical College of Wisconsin
RECRUITING
Milwaukee
West Virginia
Charleston Area Medical Center
RECRUITING
Charleston
Other Locations
Belarus
Republican Scientific and Practical Centre of Cardiology
RECRUITING
Minsk
Belgium
OLV Heart Centre
RECRUITING
Aalst
AZ Sint-Jan-Oostende AV Campus Brugge
RECRUITING
Bruges
France
Hôpital de la Timone
RECRUITING
Marseille
CHU de Rennes - Hôpital Pontchaillou
RECRUITING
Rennes
Clinique-Pasteur
RECRUITING
Toulouse
Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg Universitätsklinikum der Medizinischen Hochschule Brandenburg
RECRUITING
Bernau
Universitätsklinikum Köln (AöR)
RECRUITING
Cologne
CardioVasculäres Centrum
RECRUITING
Frankfurt
Universitätsklinikum Halle (Saale)
RECRUITING
Halle
Universitäres Herz- und Gefäßzentrum Hamburg
RECRUITING
Hamburg
Greece
Hygeia Hospital
RECRUITING
Athens
Onassis Cardiac Surgery Center
NOT_YET_RECRUITING
Kallithea
Interbalkan Medical Hospital of Thessaloniki
RECRUITING
Thessaloniki
Italy
A O U Policlinico G. Rodolico - San Marco
RECRUITING
Catania
Centro Cardiologico Monzino S.p.a
RECRUITING
Milan
IRCCS Istituto Clinico Humanitas
RECRUITING
Milan
Netherlands
St. Antonius Ziekenhuis
RECRUITING
Nieuwegein
Erasmus Medical Center
RECRUITING
Rotterdam
Serbia
Institute of Cardiovascular Diseases
RECRUITING
Belgrade
Institute of Cardiovascular Diseases of Vojvodina
RECRUITING
Belgrade
University Clinical Centre of Serbia
RECRUITING
Belgrade
University Clinical Center Niš
RECRUITING
Niš
Contact Information
Primary
Michael Zapien, MS, CCRA
mzapien@ancoraheart.com
408-727-1105
Time Frame
Start Date: 2020-12-21
Estimated Completion Date: 2030-12-21
Participants
Target number of participants: 400
Treatments
Experimental: Device group: AccuCinch Ventricular Restoration System
Subjects in this arm will receive the AccuCinch Ventricular Restoration System
Active_comparator: Control group: Guideline-Directed Medical Therapy
Subjects in this arm will receive guideline-directed medical therapy (GDMT)
Sponsors
Leads: Ancora Heart, Inc.

This content was sourced from clinicaltrials.gov