Clinical trial NCT00800046: A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
Official title: A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Regurgitation
Mitral Valve Regurgitation
Functional Mitral Regurgitation
Keywords: Mitral valve
Mitral regurgitation
Functional mitral regurgitation
MR
FMR
Heart valve
Mitral valve insufficiency
Valve repair
Valve disorder
Cardiac surgery
Lead sponsor: Ancora Heart, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety through 30 days and reduction in MR acutely and at 30 days.
timeFrame: 30 days
Secondary outcomes:
measure: Safety and reduction in MR at 1 year.
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Bad Krozingen
country: Germany
facility: University Hospital Freiburg-Bad Krozingen
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Frankfurt
country: Germany
facility: Cardiovascular Center Frankfurt
city: Hamburg
country: Germany
facility: Medical Care Center Hamburg University Cardiovascular Center
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
Study officials:
affiliation: Medical Care Center Prof. Mathey, Prof. Schofer, GmbH
name: Joachim Schofer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Center Bad Neustadt
name: Patrick Perier, MD
role: PRINCIPAL_INVESTIGATOR
References: