A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study

Mitral Regurgitation Clinical Trial

— CINCH-2  

Official title:

A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800046
• Other study ID #: 1436
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: January 2021

Study information

• Verified date: July 2021
• Source: Ancora Heart, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair.

Purpose: To demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® Ventriculoplasty System to reduce mitral valve regurgitation through subvalvular mitral repair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2021
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Severity of FMR: = Moderate (i.e., 2+)

• Ejection Fraction: = 20% to =60%

• Symptom Status: NYHA II-IVa

• Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month

• Surgical risk: Subject is eligible for cardiac surgery (specific EuroSCORE (LES or ESII), STS, or comorbidities should demonstrate high risk features)

• Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule

Exclusion Criteria:

• Significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets)

• Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days

• Prior surgical, transcatheter, or percutaneous mitral valve intervention

• Untreated clinically significant coronary artery disease (CAD) requiring revasularization

• Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support

• Any planned cardiac surgery within the next 6 months (including right heart procedures)

• NYHA class (i.e., non-ambulatory) or ACC/AHA Stage D heart failure

• Fixed pulmonary artery systolic pressure >70 mmHg

• Severe tricuspid regurgitation (per ASE guidelines and graded by the Echo Core Lab)

• Modified Rankin Scale = 4 disability

• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology

• Mitral valve area less than 4.0 cm2

• Anatomical pathology/contraints preventing appropriate access/ implant of the AccuCinch System

• Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2 ; Stage 4 or 5 CKD)

• Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation

• Active bacterial endocarditis

• History of stroke within the prior 3 months

• Subjects in whom anticoagulation or antiplatelet therapy is contraindicated

• Known allergy to nitinol, polyester, or polyethylene

• 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.

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

• Currently participating in another interventional investigational study

• Implant or revision of any rhythm management device (CRT or CRTD) or implantable cardioverter defibrillator within 1 month

• Absence of CRT with class I indication criteria for biventricular pacing (left bundle branch block pattern and QRS duration =150 ms)

• On high dose steroids or immunosuppressant therapy

• Female subjects who are pregnant or lactating

Related Conditions & MeSH terms

• Functional Mitral Regurgitation
• Mitral Regurgitation
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• AccuCinch® Ventriculoplasty System
Mitral valve repair due to functional disease

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Germany	University Hospital Freiburg-Bad Krozingen	Bad Krozingen
Germany	Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau
Germany	St.-Johannes-Hospital	Dortmund
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Cardiovascular Center Frankfurt	Frankfurt
Germany	Medical Care Center Hamburg University Cardiovascular Center	Hamburg
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Ancora Heart, Inc.

Countries where clinical trial is conducted

Austria,  Germany,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety through 30 days and reduction in MR acutely and at 30 days.		30 days
Secondary	Safety and reduction in MR at 1 year.		1 year