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 (79) 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: No
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
Recruiting
Birmingham
University of Alabama at Birmingham
Not yet recruiting
Birmingham
Arkansas
Baptist Health Heart Failure & Transplant Institute
Not yet recruiting
Little Rock
Arizona
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
Recruiting
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
Florida
JFK Medical Center
Recruiting
Atlantis
University of Miami
Recruiting
Miami
Tampa General Hospital
Recruiting
Tampa
Georgia
Emory University
Recruiting
Atlanta
Piedmont Heart Institute
Withdrawn
Atlanta
Illinois
Northwestern University
Recruiting
Chicago
University of Chicago Medical Center
Recruiting
Chicago
Advocate Good Samaritan Hospital
Recruiting
Downers Grove
Louisiana
Cardiovascular Institute of the South
Recruiting
Houma
Massachusetts
Beth Israel Deaconess Medical Center
Recruiting
Boston
Massachusetts General Hospital
Recruiting
Boston
University of Massachusetts
Not yet recruiting
Worcester
Maine
Northern Light Eastern Maine Medical Center
Not yet recruiting
Bangor
Michigan
University of Michigan
Not yet recruiting
Ann Arbor
Spectrum Health
Recruiting
Grand Rapids
William Beaumont Hospital
Not yet recruiting
Royal Oak
Minnesota
Minneapolis Heart Institute Foundation
Recruiting
Minneapolis
University of Minnesota
Recruiting
Minneapolis
Missouri
Washington University in St. Louis
Recruiting
Saint Louis
Mississippi
Jackson Heart Clinic
Recruiting
Jackson
New Jersey
Deborah Heart & Lung
Not yet recruiting
Browns Mills
Hackensack University Medical Center
Recruiting
Hackensack
Morristown Medical Center
Recruiting
Morristown
New York
Montefiore Medical Center
Recruiting
Bronx
University at Buffalo
Not yet recruiting
Buffalo
Northwell Health
Recruiting
Manhasset
CUMC/New York Presbyterian Hospital
Recruiting
New York
Mount Sinai Hospital
Recruiting
New York
Weill Cornell Medicine-New York Presbyterian Hospital
Recruiting
New York
Vassar Brothers Medical Center
Recruiting
Poughkeepsie
St. Francis Hospital
Recruiting
Roslyn
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
Not yet recruiting
Danville
Pinnacle Health Cardiovascular Institute
Recruiting
Harrisburg
Penn State Hershey Medical Center
Recruiting
Hershey
Thomas Jefferson University
Recruiting
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
Not yet recruiting
Columbia
Tennessee
Ascension Saint Thomas
Not yet recruiting
Nashville
Vanderbilt University Medical Center
Recruiting
Nashville
Texas
Austin Heart
Recruiting
Austin
Baylor College of Medicine St. Luke's Medical Center
Recruiting
Houston
Houston Heart
Recruiting
Houston
Houston Methodist Hospital
Not yet recruiting
Houston
UT Health
Not yet recruiting
Houston
Baylor Scott & White
Terminated
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
Not yet recruiting
Norfolk
CJW Chippenham Medical Center
Recruiting
Richmond
Carilion Roanoke Memorial Hospital
Recruiting
Roanoke
Washington
University of Washington
Not yet recruiting
Seattle
Wisconsin
Aurora St. Luke's Medical Center
Recruiting
Milwaukee
Contact Information
Primary
Michael Zapien, MS, CCRA
mzapien@ancoraheart.com
408-727-1105
Time Frame
Start Date: December 21, 2020
Estimated Completion Date: December 21, 2030
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)
Authors
Vivek Reddy, Liviu Klein, Guilherme Silva, George Chrysant, Timothy Byrne, Gene Kim, Mark Reisman, Saurabh Sanon, Brian Whisenant, Marwan Jumean, Thomas E. Waggoner, Sriram Rao, Eugene DePasquale, Dominick Bufalino, Peter Fail, Ivan Hanson, Ryan Tedford, Juan Bernal, Pranav Loyalka, Dean Kereiakes, Arthur Rashad Garan, Mubashir Mumtaz, Kendra Grubb, Brijeshwar Maini, Ajay Vaidya, Richard Cheng, Ryan Kaple, Rishi Puri, Timothy Raymond, Philippe Genereux, Samer Najjar, Kamran Muhammad, Vijay Iyer, Andreas Brieke, Patrick McCann, Gregory Helmer, Catalin Toma, Justin Vader, Carlos Ruiz, Sula Mazimba, Suhail Allaqaband, Gabriel Sayer, Nikolaos Kakouros, William Merhi, Abbas Bitar, Amirali Masoumi, Ulrich P Jorde, Ajith Nair, Colin Barker, Paul Gordon, Mohamed Azeem Latib, Don Chomsky, Tilak Pasala, Gerin Stevens, Shikhar Agarwal, Navin Kapur, Aasim Afzal, Andrew Sauer, Juhana Karha, Rahul Sharma, Daniel Steinberg, Konstantinos D Boudoulas, Lavanya Bellumkonda, Richard Kovach, Fadi Matar, Jason Foerst, Mohammad Ghani, William Crowder, Mustafa Ahmed, Amit Badiye, James Flaherty, Peter Eckman, Rita Jermyn, Hemal Gada, Van Selby, Mrudula Munagala, George Petrossian, Johannes Steiner, Rajeev Narayan, John Boehmer, Ali Valika, Mark Ricciardi, Bruce Rutkin, Manreet Kanwar, Matthew Price, Matthew McKay, Christine Chung, Patrick Campbell, Waqas Ghumman, Sangjin Lee, Jorge Silva Enciso, Nish Patel, Nicholas Ruggiero, Shreenvias Shreenvias, Satya Shreenvias, Justin Vadar, Funit-preet Chaudhry, Chandra Kunarvarapu, Constantino Boudoulas, Jacob Abraham, Guilherme Attizzani, Douglas Horstmanshof, Ignacio Inglessis-Azuaje, Scott Lim, Shing Chiu Wong, Benjamin DeMoss, Jorge Alvarez
Sponsors
Leads: Ancora Heart, Inc.

This content was sourced from clinicaltrials.gov

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