Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)

Pipeline Medical

Status

Completed

Conditions

Mitral Valve Regurgitation

Degenerative Mitral Valve Disease

Treatments

Device: Transcatheter implantation of chordal repair system

Study type

Interventional

Funder types

Industry

Identifiers

NCT04281940

CIP-0001

Details and patient eligibility

About

A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair.

Full description

The proposed study is a prospective, multi-center, interventional investigation enrolling up to 30 subjects in multiple sites in Latin America and Eastern Europe.

The primary objective of this study is to collect preliminary information on the performance and safety of the Pipeline Chordal Repair System in percutaneous reduction of significant mitral regurgitation (MR ≥ moderate) due to primary abnormality of the mitral apparatus [degenerative MR].

Enrollment

7 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Presence of moderate to severe Mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure.
Estimated post-ePTFE chordae tendineae implantation coaptation surface is adequate in the judgment of the operating physician and the patient eligibility committee.
Degenerative mitral valve disease.
Patients who have been evaluated and no contraindication has been found for open heart surgery OR candidates for mitral valve surgery who, according to current guidelines, are at elevated surgical risk AND for whom transcatheter therapy is deemed more appropriate than open heart surgery in the judgement of the Site Heart Team.

Exclusion criteria

Untreated clinically significant coronary artery disease requiring revascularization
Creatine Kinase-MB (CK-MB) obtained within prior 14 days > local laboratory Upper Limit of Normal (ULN)
Age <30/40 or > 85 years
Presence of any of the following:
Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg assessed by site based on echocardiography or right heart catheterization
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, ischemic or non-ischemic Functional mitral regurgitation or any other structural heart disease causing heart failure
Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
Hemodynamic instability requiring inotropic support or mechanical heart assistance
Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device
Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction
Left Ventricular Ejection Fraction (LVEF) is < 30% (within 90 days prior to subject enrollment, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI))
Mitral annular diameter >45mm in any dimension. Left Ventricular End Diastolic Diameter (LVEDD) > 65mm. Left Ventricular End Systolic Dimension (LVESD) > 55 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject enrollment
Coronary artery bypass grafting (CABG) within 30 days prior to subject's consent
Percutaneous coronary intervention within 30 days prior to subject's consent
Tricuspid valve disease requiring surgery
Aortic valve disease requiring surgery or TAVI
Carotid surgery within 30 days prior to subject's consent
Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30 days prior to subject's consent
Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
Status 1 heart transplant or prior orthotopic heart transplantation
Chronic Kidney Disease with a baseline serum creatinine > 1.5mg/dL
Chronic Steroid Therapy
Cerebrovascular accident within 30 days prior to subject's consent
Severe symptomatic carotid stenosis (> 70 % via ultrasound)
Life expectancy < 12 months due to non-cardiac conditions
Active infections requiring current antibiotic therapy
Pregnant or planning pregnancy within next 12 months
Currently participating in an investigational drug or another device study
Severe organic lesions with mitral chords retraction, severely fibrotic and immobile leaflets, severely deformed subvalvular apparatus
Evolving endocarditis or active endocarditis in the last 3 months
Heavily calcified or dilated annulus or leaflets, mitral valve stenosis
Congenital malformation with limited valvular tissue
Patient requires mitral valve replacement
Previously implanted prosthetic mitral valve or annuloplasty ring/band
Evidence of LV or LA thrombus, vegetation or mass
Severe tricuspid regurgitation or severe RV dysfunction
Condition that prevents transfemoral access
Anatomical ineligibility to the investigational device
Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium