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

• Sponsor: Ancora Heart, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04331769
• Collaborator: (none)
• Enrollment: 400
• Locations: 67
• Arms: 2
• Anticipated Duration (Months): 120
• Patients Per Site: 6
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Reduced Ejection Fraction (HFrEF); Dilated Cardiomyopathy	Device: AccuCinch Ventricular Restoration System; Drug: Guideline-Directed Medical Therapy	N/A

Detailed 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)

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 21, 2020
• Anticipated Primary Completion Date: Jun 21, 2024
• Anticipated Study Completion Date: Dec 21, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device group: AccuCinch Ventricular Restoration System Subjects in this arm will receive the AccuCinch Ventricular Restoration System	Device: AccuCinch Ventricular Restoration System; AccuCinch Ventricular Restoration System
Active Comparator: Control group: Guideline-Directed Medical Therapy Subjects in this arm will receive guideline-directed medical therapy (GDMT)	Drug: Guideline-Directed Medical Therapy; Guideline-Directed Medical Therapy

Outcome Measures

Primary Outcome Measures

1. Freedom from device- or femoral artery access-related major adverse events (MAE) [180 days]

   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

2. Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score [180 days]

   Higher scores in the KCCQ reflect better health status

3. 6-Minute Walk Test (6MWT) distance (m) [180 days]

   Change in 6MWT distance (m) from baseline

4. Freedom from device- or femoral artery access-related major adverse events (MAE) [365 days]

   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

5. 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) [365 days]

   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

Secondary Outcome Measures

1. Number of all-cause deaths or all-cause hospitalizations [30 days, 90 days, 180 days, 365 days, 545 days, 730 days]

2. Number of all-cause deaths [30 days, 90 days, 180 days, 365 days, 545 days, 730 days]

3. Number of all-cause hospitalizations [30 days, 90 days, 180 days, 365 days, 545 days, 730 days]

4. Incidence of all serious adverse events, including device- and procedure- related complications [30 days, 90 days, 180 days, 365 days, 545 days, 730 days]

5. Changes from baseline in New York Heart Association (NYHA) functional class [30 days, 90 days, 180 days, 365 days, 545 days, 730 days]

6. Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) [30 days, 90 days, 365 days, 545 days, 730 days]

   Higher scores in the KCCQ reflect better health status

7. Changes from baseline in 6-Minute Walk Test (6MWT) [30 days, 90 days, 365 days, 545 days, 730 days]

   Measure in meters

8. 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]

9. Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT [180 days]

10. 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]

11. 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]

12. 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]

13. 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]

14. Rate and number of cardiovascular death events [30 days, 90 days, 180 days, 365 days, 545 days, 730 days]

15. Rate and number of heart failure death events [30 days, 90 days, 180 days, 365 days, 545 days, 730 days]

16. Rate and number of heart failure-related hospitalizations [30 days, 90 days, 180 days, 365 days, 545 days, 730 days]

Other Outcome Measures

1. Changes from baseline in mitral effective regurgitant orifice area (EROA) [30 days, 90 days, 180 days, 365 days, 730 days]

2. Changes from baseline in left atrial strain measured by Echo [30 days, 90 days, 180 days, 365 days, 730 days]

3. Changes from baseline in left ventricular global longitudinal strain measured by Echo [30 days, 90 days, 180 days, 365 days, 730 days]

4. Changes from baseline in right ventricular free wall longitudinal strain measured by Echo [30 days, 90 days, 180 days, 365 days, 730 days]

5. Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) individual domains [30 days, 90 days, 180 days, 365 days, 545 days, 730 days]

   Higher scores in the KCCQ reflect better health status

6. Changes from baseline in EuroQol Five Dimension Five Level (EQ-5D-5L) Quality of Life Questionnaire [30 days, 90 days, 180 days, 365 days, 545 days, 730 days]

   Lower scores in the EQ-5D-5L reflect better health status

7. Changes from baseline in right ventricular (RV) fractional area change measured by Echo [30 days, 90 days, 180 days, 365 days, 730 days]

   Measured by percent change

8. Changes from baseline in tricuspid annular plane systolic excursion (TAPSE) measured by Echo [30 days, 90 days, 180 days, 365 days, 730 days]

   Measured in centimeters or millimeters

9. Changes from baseline in tricuspid regurgitation measured by Echo [30 days, 90 days, 180 days, 365 days, 730 days]

   Measured using effective regurgitant orifice area (mm2) and regurgitant volume (mL)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

5. NYHA III,

6. NYHA ambulatory IV, or

7. NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)

8. Able to complete six-minute walk test with distance between 100 m and 450 m.

9. 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.

10. "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

11. 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

12. 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)

13. When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments

14. 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

15. 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

16. If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments

17. 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)

18. 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

19. 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

1. Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)

2. Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable)

3. Prior mitral or aortic valve replacement

4. Tricuspid regurgitation grade 4+ (severe)

5. Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax >300 cm/sec)

6. Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe)

Procedural

1. 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)

2. Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2)

3. Subjects in whom anticoagulation during the procedure is contraindicated

4. Subjects in whom 90 days of antiplatelet therapy is contraindicated

5. Known allergy to nitinol, polyester, or polyethylene

6. 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

1. Life expectancy <1 year due to non-cardiac conditions

2. Currently participating in another interventional investigational study

3. Subjects on high dose steroids or immunosuppressant therapy

4. Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grandview Medical Group Research, LLC	Birmingham	Alabama	United States	35243
2	Phoenix Cardiovascular Research Group	Phoenix	Arizona	United States	85016
3	Tucson Medical Center	Tucson	Arizona	United States	85712
4	University of California San Diego	La Jolla	California	United States	92037
5	Scripps Health	La Jolla	California	United States	92121
6	University of Southern California	Los Angeles	California	United States	90033
7	Kaiser Permanente San Francisco	San Francisco	California	United States	94115
8	University of California, San Francisco	San Francisco	California	United States	94143
9	University of Colorado	Aurora	Colorado	United States	80045
10	Hartford Health	Hartford	Connecticut	United States	06102
11	Yale University	New Haven	Connecticut	United States	06519
12	Medstar Health Research Institute	Washington	District of Columbia	United States	20010
13	JFK Medical Center	Atlantis	Florida	United States	33462
14	University of Miami	Miami	Florida	United States	33136
15	Tampa General Hospital	Tampa	Florida	United States	33606
16	Emory University	Atlanta	Georgia	United States	30308
17	Piedmont Heart Institute	Atlanta	Georgia	United States	30309
18	Northwestern University	Chicago	Illinois	United States	60611
19	University of Chicago Medical Center	Chicago	Illinois	United States	60637
20	Advocate Good Samaritan Hospital	Downers Grove	Illinois	United States	60515
21	Northshore University Health Systems	Evanston	Illinois	United States	60201
22	Cardiovascular Institute of the South	Houma	Louisiana	United States	70360
23	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
24	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
25	Spectrum Health	Grand Rapids	Michigan	United States	49503
26	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407
27	University of Minnesota	Minneapolis	Minnesota	United States	55414
28	Jackson Heart Clinic	Jackson	Mississippi	United States	39216
29	Washington University in St. Louis	Saint Louis	Missouri	United States	63110
30	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
31	Morristown Medical Center	Morristown	New Jersey	United States	07960
32	Montefiore Medical Center	Bronx	New York	United States	10467
33	Northwell Health	Manhasset	New York	United States	11030
34	Mount Sinai Hospital	New York	New York	United States	10029
35	CUMC/New York Presbyterian Hospital	New York	New York	United States	10032
36	Weill Cornell Medicine-New York Presbyterian Hospital	New York	New York	United States	10065
37	Vassar Brothers Medical Center	Poughkeepsie	New York	United States	12601
38	St. Francis Hospital	Roslyn	New York	United States	11576
39	The Christ Hospital	Cincinnati	Ohio	United States	45219
40	UH Cleveland Medical Center	Cleveland	Ohio	United States	44106
41	Cleveland Clinic	Cleveland	Ohio	United States	44195
42	Ohio State University	Columbus	Ohio	United States	43210
43	INTEGRIS Baptist Medical Center	Oklahoma City	Oklahoma	United States	73112
44	Oklahoma Heart Hospital	Oklahoma City	Oklahoma	United States	73120
45	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
46	Oregon Health & Science University	Portland	Oregon	United States	97239
47	Geisinger Clinic	Danville	Pennsylvania	United States	17822
48	Pinnacle Health Cardiovascular Institute	Harrisburg	Pennsylvania	United States	17101
49	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States	17033
50	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
51	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
52	UPMC Heart and Vascular Institute	Pittsburgh	Pennsylvania	United States	15232
53	Rhode Island Hospital	Providence	Rhode Island	United States	02904
54	Medical University of South Carolina	Charleston	South Carolina	United States	29425
55	Vanderbilt University Medical Center	Nashville	Tennessee	United States	87232
56	Austin Heart	Austin	Texas	United States	78756
57	Houston Heart	Houston	Texas	United States	77004
58	Baylor College of Medicine St. Luke's Medical Center	Houston	Texas	United States	77020
59	Houston Methodist Hospital	Houston	Texas	United States	77030
60	Baylor Scott & White	Plano	Texas	United States	75093
61	Methodist Healthcare System, San Antonio	San Antonio	Texas	United States	78229
62	Intermountain Medical Center	Salt Lake City	Utah	United States	84109
63	University of Virginia Health System	Charlottesville	Virginia	United States	22908
64	CJW Chippenham Medical Center	Richmond	Virginia	United States	23225
65	Carilion Roanoke Memorial Hospital	Roanoke	Virginia	United States	24014
66	University of Washington	Seattle	Washington	United States	98195
67	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

• Ancora Heart, Inc.

Investigators

• Study Chair: Martin B Leon, MD, Columbia University
• Principal Investigator: Ulrich P Jorde, MD, Montefiore Medical Center/Albert Einstein College of Medicine
• Principal Investigator: Mark Reisman, MD, New York Presbyterian/Weill Cornell Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ancora Heart, Inc.
• ClinicalTrials.gov Identifier: NCT04331769
• Other Study ID Numbers: 5019
• First Posted: Apr 2, 2020
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Ancora Heart, Inc.: Heart Failure; Reduced Ejection Fraction; Cardiomyopathy
• Additional relevant MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated

Study Results

No Results Posted as of Apr 6, 2022