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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04331769
Other study ID # 5019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 21, 2020
Est. completion date December 21, 2030

Study information

Verified date March 2024
Source Ancora Heart, Inc.
Contact Michael Zapien, MS, CCRA
Phone 408-727-1105
Email mzapien@ancoraheart.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 21, 2030
Est. primary completion date June 21, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age 18-years or older 2. Ejection Fraction: =20% and =40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab 3. LV end-diastolic diameter =55 mm measured by TTE and assessed by an echo core lab 4. Symptom Status: 1. NYHA III, 2. NYHA ambulatory IV, or 3. NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent) 5. Able to complete six-minute walk test with distance between 100 m and 450 m. 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. 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 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 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) 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 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 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 7. If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments 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) 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 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 Exclusion Criteria: Cardiovascular 1. Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent 2. Untreated clinically significant coronary artery disease (CAD) requiring revascularization 3. Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation 4. Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan 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. Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support 7. Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures) 8. Active bacterial endocarditis 9. Severe RV dysfunction assessed by right heart catheterization (RHC) and/or TTE 10. Fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy 11. History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale = 2 disability from any prior stroke Valvular 12. Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe) 13. Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable) 14. Prior mitral or aortic valve replacement 15. Tricuspid regurgitation grade 4+ (severe) 16. Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax >300 cm/sec) 17. Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe) Procedural 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. Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2) 20. Subjects in whom anticoagulation during the procedure is contraindicated 21. Subjects in whom 90 days of antiplatelet therapy is contraindicated 22. Known allergy to nitinol, polyester, or polyethylene 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 General 24. Life expectancy <1 year due to non-cardiac conditions 25. Currently participating in another interventional investigational study 26. Subjects on high dose steroids or immunosuppressant therapy 27. Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AccuCinch Ventricular Restoration System
AccuCinch Ventricular Restoration System
Drug:
Guideline-Directed Medical Therapy
Guideline-Directed Medical Therapy

Locations

Country Name City State
Belarus Republican Scientific and Practical Centre of Cardiology Minsk
Belgium OLV Heart Centre Aalst
Belgium AZ Sint-Jan-Oostende AV Campus Brugge Brugge
Czechia St. Anne's University Hospital Brno
Czechia Na Homolce Hospital Prague
France Hôpital de la Timone Marseille
France CHU de Rennes - Hôpital Pontchaillou Rennes
France Clinique-Pasteur Toulouse
Netherlands St. Antonius Ziekenhuis Nieuwegein
Netherlands Erasmus Medical Center Rotterdam
Serbia Institute of Cardiovascular Diseases Belgrade
Serbia Institute of Cardiovascular Diseases of Vojvodina Belgrade
Serbia University Clinical Centre of Serbia Belgrade
United States University of Michigan Ann Arbor Michigan
United States Emory University Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Piedmont Heart Institute Atlanta Georgia
United States JFK Medical Center Atlantis Florida
United States University of Colorado Aurora Colorado
United States Ascension Texas Cardiovascular Austin Texas
United States Austin Heart Austin Texas
United States University of Maryland Medical Center Baltimore Maryland
United States Northern Light Eastern Maine Medical Center Bangor Maine
United States Our Lady of the Lake Regional Medical Center Baton Rouge Louisiana
United States Grandview Medical Group Research, LLC Birmingham Alabama
United States University of Alabama at Birmingham Birmingham Alabama
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Deborah Heart & Lung Browns Mills New Jersey
United States University at Buffalo Buffalo New York
United States Charleston Area Medical Center Charleston West Virginia
United States Medical University of South Carolina Charleston South Carolina
United States University of Virginia Health System Charlottesville Virginia
United States Northwestern University Chicago Illinois
United States University of Chicago Medical Center Chicago Illinois
United States The Christ Hospital Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States UH Cleveland Medical Center Cleveland Ohio
United States Prisma Health Columbia South Carolina
United States Ohio State University Columbus Ohio
United States Metropolitan Heart and Vascular Institute & Mercy Hosp Coon Rapids Minnesota
United States Baylor Scott & White Research Institute Dallas Texas
United States Geisinger Clinic Danville Pennsylvania
United States Advocate Good Samaritan Hospital Downers Grove Illinois
United States Spectrum Health Grand Rapids Michigan
United States Hackensack University Medical Center Hackensack New Jersey
United States Pinnacle Health Cardiovascular Institute Harrisburg Pennsylvania
United States Hartford Health Hartford Connecticut
United States Penn State Hershey Medical Center Hershey Pennsylvania
United States Cardiovascular Institute of the South Houma Louisiana
United States Baylor College of Medicine St. Luke's Medical Center Houston Texas
United States Houston Heart Houston Texas
United States Houston Methodist Hospital Houston Texas
United States UT Health Houston Texas
United States Jackson Heart Clinic Jackson Mississippi
United States Tennova Healthcare-Turkey Creek Medical Center Knoxville Tennessee
United States Scripps Health La Jolla California
United States University of California San Diego La Jolla California
United States HCA Florida Largo Hospital Largo Florida
United States Baptist Health Heart Failure & Transplant Institute Little Rock Arkansas
United States University of Southern California Los Angeles California
United States Norton Heart Specialists Louisville Kentucky
United States Texas Tech University Health Sciences Center Lubbock Texas
United States Northwell Health Manhasset New York
United States University of Miami Miami Florida
United States Aurora St. Luke's Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States University of Minnesota Minneapolis Minnesota
United States Morristown Medical Center Morristown New Jersey
United States Ascension Saint Thomas Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale University New Haven Connecticut
United States CUMC/New York Presbyterian Hospital New York New York
United States Mount Sinai Hospital New York New York
United States NYU Langone Health New York New York
United States Weill Cornell Medicine-New York Presbyterian Hospital New York New York
United States Sentara Norfolk General Hospital Norfolk Virginia
United States INTEGRIS Baptist Medical Center Oklahoma City Oklahoma
United States Oklahoma Heart Hospital Oklahoma City Oklahoma
United States Ascension Sacred Heart Pensacola Florida
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Phoenix Cardiovascular Research Group Phoenix Arizona
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States UPMC Heart and Vascular Institute Pittsburgh Pennsylvania
United States Baylor Scott & White Plano Texas
United States Oregon Health & Science University Portland Oregon
United States Providence St. Vincent Medical Center Portland Oregon
United States Vassar Brothers Medical Center Poughkeepsie New York
United States Rhode Island Hospital Providence Rhode Island
United States NC Heart and Vascular Research, LLC Raleigh North Carolina
United States CJW Chippenham Medical Center Richmond Virginia
United States Carilion Roanoke Memorial Hospital Roanoke Virginia
United States St. Francis Hospital Roslyn New York
United States William Beaumont Hospital Royal Oak Michigan
United States Washington University in St. Louis Saint Louis Missouri
United States Intermountain Medical Center Salt Lake City Utah
United States Methodist Healthcare System, San Antonio San Antonio Texas
United States Kaiser Permanente San Francisco San Francisco California
United States University of California, San Francisco San Francisco California
United States University of Washington Seattle Washington
United States Ascension Providence Hospital Southfield Michigan
United States Providence Sacred Heart Medical Center Spokane Washington
United States University of South Florida Tampa Florida
United States Tucson Medical Center Tucson Arizona
United States Oklahoma Heart Institute Tulsa Oklahoma
United States Medstar Health Research Institute Washington District of Columbia
United States Cardiovascular Research Institute of Kansas Wichita Kansas
United States Valley Health Winchester Winchester Virginia
United States University of Massachusetts Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Ancora Heart, Inc.

Countries where clinical trial is conducted

United States,  Belarus,  Belgium,  Czechia,  France,  Netherlands,  Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes from baseline in mitral effective regurgitant orifice area (EROA) 30 days, 90 days, 180 days, 365 days, 730 days
Other Changes from baseline in left atrial strain measured by Echo 30 days, 90 days, 180 days, 365 days, 730 days
Other Changes from baseline in left ventricular global longitudinal strain measured by Echo 30 days, 90 days, 180 days, 365 days, 730 days
Other Changes from baseline in right ventricular free wall longitudinal strain measured by Echo 30 days, 90 days, 180 days, 365 days, 730 days
Other Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) individual domains Higher scores in the KCCQ reflect better health status 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Other Changes from baseline in EuroQol Five Dimension Five Level (EQ-5D-5L) Quality of Life Questionnaire Lower scores in the EQ-5D-5L reflect better health status 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Other Changes from baseline in right ventricular (RV) fractional area change measured by Echo Measured by percent change 30 days, 90 days, 180 days, 365 days, 730 days
Other Changes from baseline in tricuspid annular plane systolic excursion (TAPSE) measured by Echo Measured in centimeters or millimeters 30 days, 90 days, 180 days, 365 days, 730 days
Other Changes from baseline in tricuspid regurgitation measured by Echo Measured using effective regurgitant orifice area (mm2) and regurgitant volume (mL) 30 days, 90 days, 180 days, 365 days, 730 days
Primary Freedom from device- or femoral artery access-related major adverse events (MAE) MAE defined as:
All-cause death,
Myocardial infarction,
Stroke,
Need for non-elective cardiovascular surgery,
Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours
Acute kidney injury requiring renal replacement therapy
180 days
Primary Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score Higher scores in the KCCQ reflect better health status 180 days
Primary 6-Minute Walk Test (6MWT) distance (m) Change in 6MWT distance (m) from baseline 180 days
Primary Freedom from device- or femoral artery access-related major adverse events (MAE) MAE defined as:
All-cause death,
Myocardial infarction,
Stroke,
Need for non-elective cardiovascular surgery,
Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours
Acute kidney injury requiring renal replacement therapy
365 days
Primary 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) 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 365 days
Secondary Number of all-cause deaths or all-cause hospitalizations 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Secondary Number of all-cause deaths 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Secondary Number of all-cause hospitalizations 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Secondary Incidence of all serious adverse events, including device- and procedure- related complications 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Secondary Changes from baseline in New York Heart Association (NYHA) functional class 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Secondary Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) Higher scores in the KCCQ reflect better health status 30 days, 90 days, 365 days, 545 days, 730 days
Secondary Changes from baseline in 6-Minute Walk Test (6MWT) Measure in meters 30 days, 90 days, 365 days, 545 days, 730 days
Secondary 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
Secondary Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT 180 days
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Rate and number of cardiovascular death events 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Secondary Rate and number of heart failure death events 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Secondary Rate and number of heart failure-related hospitalizations 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
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