Mitral Valve Replacement With MValve Dock and Lotus

NCT ID: NCT02719912

Last Updated: 2016-03-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-07-31

Brief Summary

This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter heart valve (THV) for mitral valve replacement in subjects at high risk for conventional mitral valve replacement or repair surgery.

Detailed Description

This study is a prospective first in man feasibility study intended to evaluate preliminary safety and effectiveness of the MValve Mitral Dock with Lotus transcatheter heart valve for mitral valve replacement in subjects who are at high risk for surgical valve repair or replacement.

The surgical technique adapts the valve-in-valve approach for mitral replacement in degenerated mitral prostheses to failing native mitral valves. The MValve Dock is designed to provide a structural platform within the mitral annulus so that the Lotus THV can be implanted in a secure fashion in the mitral annulus. The investigational device anchors to the mitral annulus commissures, sparing the native valve leaflets and sub annular apparatus. This study is designed to treat subjects with moderate-to-severe MR who are not deemed candidates for mitral valve surgery.

Conditions

Mitral Valve Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Valve Replacement

Mitral valve replacement

Group Type: EXPERIMENTAL

mitral valve replacement

Intervention Type: DEVICE

transcatheter mitral valve replacement

Interventions

mitral valve replacement

transcatheter mitral valve replacement

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Symptomatic ≥3+ degenerative or functional mitral regurgitation of either ischemic or non-ischemic etiology based by a qualifying echocardiography obtained within 90 days prior to the procedure.
• New York Heart Association (NYHA) Functional Class III or IV.
• High risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team.
• Left Ventricular Ejection Fraction (LVEF) is ≥30% within 30 days prior to the procedure.
• Mitral valve annular commissure to commissure (C/C) dimension between 30-35 mm by echocardiography.
• Left atrial diameter <5.5 cm by echocardiography

Exclusion Criteria

• Prior mitral valve replacement or repair surgery.
• Prior transapical surgery.
• Severe aortic or tricuspid valve disease. - Severe symptomatic carotid stenosis (>70% by ultrasound).
• ACC/AHA Stage D heart failure.
• 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.
• Infiltrative cardiomyopathies (amyloidosis, hemochromatosis, sarcoidosis).
• Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
• Severe mitral annular calcification.
• Glomerular filtration rate (GFR) < 30.
• Hemodynamic instability defined as systolic pressure < 90 mm Hg with or without afterload reduction, cardiogenic shock, or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MValve Technologies Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dante Pazzenese Institute of Cardiology

Sau Paulo, , Brazil

Clinique Pasteur

Toulouse, , France

University of Bonn - Medizinische Klinik und Poliklinik II

Bonn, , Germany

University of Poznan

Poznan, , Poland

Countries

Brazil; France; Germany; Poland

Facility Contacts

Alexander Abizaid, MD

Role: primary

Role: backup

aabizaid@uol.com.br

Frederic Petit

Role: primary

fpetit@clinique-pasteur.com

Kaja Twelker, MD

Role: primary

kaja.twelker@ukb.uni-bonn.de

Maciej Lesiak, MD

Role: primary

Role: backup

maciej.lesiak@skpp.edu.pl

Other Identifiers

CIP 01-2015

Identifier Type: -

Identifier Source: org_study_id