Actively 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
Led by Ancora Heart, Inc. · Updated on 2025-12-11
400
Participants Needed
132
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ejection fraction between 20% and 40% measured by transthoracic echocardiography assessed by an echo core lab
- Left ventricular end-diastolic diameter of 55 mm or greater measured by transthoracic echocardiography assessed by an echo core lab
- Symptom status classified as NYHA III, NYHA ambulatory IV, or NYHA II with a heart failure hospitalization within the prior 12 months
- Able to complete a six-minute walk test with distance between 100 m and 450 m
- Diagnosis and treatment for heart failure established at least 90 days before consent
- On stable and optimized medical therapy for at least 30 days as recommended by current guidelines, with any intolerance documented
- If applicable, guideline-directed devices such as CRT must be placed over 90 days before screening, and ICD must be placed over 30 days before screening
- Able and willing to complete all qualifying diagnostic and functional tests, accept blood transfusion if required, and comply with follow-up schedule
You will not qualify if you...
- Myocardial infarction or cardiovascular interventions or surgeries within 90 days prior to consent
- Untreated significant coronary artery disease requiring revascularization
- Severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation seen on fluoroscopy or echocardiography
- Suboptimal ventricular anatomy or wall thickness
- Heart failure due to causes other than ischemic or non-ischemic dilated cardiomyopathy
- Hemodynamic instability requiring inotropic or mechanical support within 30 days prior to implant
- Planned cardiac surgery or interventions within 180 days post-randomization
- Active bacterial endocarditis
- Severe right ventricular dysfunction
- Fixed pulmonary hypertension with pulmonary artery systolic pressure over 70 mmHg not responsive to vasodilators
- History of stroke within 90 days or significant disability from prior stroke
- Moderate to severe mitral regurgitation or untreated degenerative mitral valve disease
- Prior mitral or aortic valve replacement
- Severe tricuspid regurgitation
- Moderate or severe aortic valve stenosis or moderate to severe aortic regurgitation
- Anatomical issues preventing device access or implant
- Renal insufficiency with eGFR less than 25 ml/min/1.73 m2
- Contraindications to anticoagulation or required antiplatelet therapy
- Allergies to device materials or contrast agents
- Life expectancy under one year from non-cardiac causes
- Participation in another interventional study
- Use of high dose steroids or immunosuppressants
- Pregnancy, lactation, or childbearing potential without birth control documented
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 132 locations
1
Grandview Medical Group Research, LLC
Birmingham, Alabama, United States, 35243
Terminated
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Withdrawn
3
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
4
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States, 85016
Actively Recruiting
5
Tucson Medical Center
Tucson, Arizona, United States, 85712
Actively Recruiting
6
Baptist Health Heart Failure & Transplant Institute
Little Rock, Arkansas, United States, 72205
Withdrawn
7
University of California San Diego
La Jolla, California, United States, 92037
Actively Recruiting
8
Scripps Health
La Jolla, California, United States, 92121
Actively Recruiting
9
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
10
Kaiser Permanente San Francisco
San Francisco, California, United States, 94115
Completed
11
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
12
University of Colorado
Aurora, Colorado, United States, 80045
Withdrawn
13
Hartford Health
Hartford, Connecticut, United States, 06102
Actively Recruiting
14
Yale University
New Haven, Connecticut, United States, 06519
Actively Recruiting
15
Medstar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
16
JFK Medical Center
Atlantis, Florida, United States, 33462
Terminated
17
HCA Florida Largo Hospital
Largo, Florida, United States, 33770
Actively Recruiting
18
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
19
Ascension Sacred Heart
Pensacola, Florida, United States, 32504
Actively Recruiting
20
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
21
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
22
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Withdrawn
23
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
24
Northwestern University
Chicago, Illinois, United States, 60611
Withdrawn
25
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
26
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States, 60515
Actively Recruiting
27
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
28
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States, 67226
Actively Recruiting
29
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
30
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
31
Norton Heart Specialists
Louisville, Kentucky, United States, 40216
Actively Recruiting
32
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
33
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
34
Northern Light Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Actively Recruiting
35
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
36
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
37
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
38
University of Massachusetts
Worcester, Massachusetts, United States, 01655
Actively Recruiting
39
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
40
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
41
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Completed
42
Ascension Providence Hospital
Southfield, Michigan, United States, 48075
Actively Recruiting
43
Metropolitan Heart and Vascular Institute & Mercy Hosp
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
44
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
45
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
46
Jackson Heart Clinic
Jackson, Mississippi, United States, 39216
Actively Recruiting
47
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
48
Deborah Heart & Lung
Browns Mills, New Jersey, United States, 08015
Actively Recruiting
49
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
50
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Withdrawn
51
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
52
New Mexico Heart Institute
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
53
University at Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
54
Northwell Health
Manhasset, New York, United States, 11030
Actively Recruiting
55
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
56
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
57
CUMC/New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
58
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
59
Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601
Completed
60
St. Francis Hospital
Roslyn, New York, United States, 11576
Actively Recruiting
61
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
62
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
63
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, United States, 27607
Actively Recruiting
64
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
65
UH Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Withdrawn
66
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
67
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
68
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
69
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
Actively Recruiting
70
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
71
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
72
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
73
Geisinger Clinic
Danville, Pennsylvania, United States, 17822
Actively Recruiting
74
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, United States, 17101
Withdrawn
75
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
76
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Completed
77
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
78
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
79
Rhode Island Hospital
Providence, Rhode Island, United States, 02904
Actively Recruiting
80
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
81
Prisma Health
Columbia, South Carolina, United States, 29203
Actively Recruiting
82
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, United States, 37934
Actively Recruiting
83
Ascension Saint Thomas
Nashville, Tennessee, United States, 37221
Actively Recruiting
84
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 87232
Actively Recruiting
85
Ascension Texas Cardiovascular
Austin, Texas, United States, 78705
Actively Recruiting
86
Austin Heart
Austin, Texas, United States, 78756
Completed
87
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75226
Actively Recruiting
88
Houston Heart
Houston, Texas, United States, 77004
Actively Recruiting
89
Baylor College of Medicine St. Luke's Medical Center
Houston, Texas, United States, 77020
Actively Recruiting
90
Houston Methodist Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
91
UT Health
Houston, Texas, United States, 77030
Actively Recruiting
92
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Actively Recruiting
93
Baylor Scott & White
Plano, Texas, United States, 75093
Completed
94
Methodist Healthcare System, San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
95
Intermountain Medical Center
Salt Lake City, Utah, United States, 84109
Actively Recruiting
96
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
97
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Terminated
98
CJW Chippenham Medical Center
Richmond, Virginia, United States, 23225
Terminated
99
Bon Secours St Mary's Hospital
Richmond, Virginia, United States, 23226
Actively Recruiting
100
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24014
Actively Recruiting
101
Valley Health Winchester
Winchester, Virginia, United States, 22601
Actively Recruiting
102
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
103
Providence Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Actively Recruiting
104
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
Actively Recruiting
105
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
106
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
107
Republican Scientific and Practical Centre of Cardiology
Minsk, Belarus, 220036
Actively Recruiting
108
OLV Heart Centre
Aalst, Belgium, 9300
Actively Recruiting
109
AZ Sint-Jan-Oostende AV Campus Brugge
Bruges, Belgium
Actively Recruiting
110
St. Anne's University Hospital
Brno, Czechia, 60200
Actively Recruiting
111
Na Homolce Hospital
Prague, Czechia
Actively Recruiting
112
Hôpital de la Timone
Marseille, France, 13005
Actively Recruiting
113
CHU de Rennes - Hôpital Pontchaillou
Rennes, France, 35033
Actively Recruiting
114
Clinique-Pasteur
Toulouse, France, 31300
Actively Recruiting
115
Immanuel Klinikum Bernau Herzzentrum Brandenburg Universitätsklinikum der Medizinischen Hochschule Brandenburg
Bernau, Germany, 16321
Actively Recruiting
116
Universitätsklinikum Köln (AöR)
Cologne, Germany, 50937
Actively Recruiting
117
CardioVasculäres Centrum
Frankfurt, Germany, 60389
Actively Recruiting
118
Universitätsklinikum Halle (Saale)
Halle, Germany, 06120
Actively Recruiting
119
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, Germany, 20246
Actively Recruiting
120
Hygeia Hospital
Athens, Greece
Actively Recruiting
121
Onassis Cardiac Surgery Center
Kallithea, Greece, 17674
Not Yet Recruiting
122
Interbalkan Medical Hospital of Thessaloniki
Thessaloniki, Greece, 57001
Actively Recruiting
123
A O U Policlinico G. Rodolico - San Marco
Catania, Catania, Italy, 95123
Actively Recruiting
124
IRCCS Istituto Clinico Humanitas
Milan, Lombardy, Italy, 20089
Actively Recruiting
125
AOU Città della salute e della Scienza - Ospedale Molinette
Torino, Torino, Italy, 10126
Actively Recruiting
126
Centro Cardiologico Monzino S.p.a
Milan, Italy, 20138
Actively Recruiting
127
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Actively Recruiting
128
Erasmus Medical Center
Rotterdam, Netherlands
Actively Recruiting
129
Institute of Cardiovascular Diseases of Vojvodina
Belgrade, Serbia, 11000
Actively Recruiting
130
Institute of Cardiovascular Diseases
Belgrade, Serbia, 11000
Actively Recruiting
131
University Clinical Centre of Serbia
Belgrade, Serbia, 11000
Actively Recruiting
132
University Clinical Center Niš
Niš, Serbia, 18108
Actively Recruiting
Research Team
M
Michael Zapien, MS, CCRA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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