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

Sponsor

Ancora Heart, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00800046

Collaborator

(none)

Enrollment

Locations

Arm

146

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation Mitral Valve Regurgitation Functional Mitral Regurgitation	Device: AccuCinch® Ventriculoplasty System	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Nov 1, 2020

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AccuCinch® Ventriculoplasty System Patients meeting the enrollment criteria will be treated with the AccuCinch® Ventriculoplasty System.	Device: AccuCinch® Ventriculoplasty System Mitral valve repair due to functional disease

Arm

Intervention/Treatment

Experimental: AccuCinch® Ventriculoplasty System

Patients meeting the enrollment criteria will be treated with the AccuCinch® Ventriculoplasty System.

Device: AccuCinch® Ventriculoplasty System

Mitral valve repair due to functional disease

Outcome Measures

Primary Outcome Measures

Safety through 30 days and reduction in MR acutely and at 30 days. [30 days]

Secondary Outcome Measures

Safety and reduction in MR at 1 year. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Medical University of Vienna	Vienna	Austria
2	University Hospital Freiburg-Bad Krozingen	Bad Krozingen	Germany
3	Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau	Germany
4	St.-Johannes-Hospital	Dortmund	Germany
5	Universitätsklinikum Düsseldorf	Düsseldorf	Germany
6	Cardiovascular Center Frankfurt	Frankfurt	Germany
7	Medical Care Center Hamburg University Cardiovascular Center	Hamburg	Germany	22527
8	Vilnius University Hospital Santaros Klinikos	Vilnius	Lithuania

Sponsors and Collaborators

Ancora Heart, Inc.

Investigators

Principal Investigator: Joachim Schofer, Prof. Dr., Medical Care Center Prof. Mathey, Prof. Schofer, GmbH
Principal Investigator: Patrick Perier, MD, Cardiovascular Center Bad Neustadt