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

Dilated Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04331769
• Other study ID #: 5019
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Heart Failure
• Heart Failure With Reduced Ejection Fraction (HFrEF)

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