Mitral Valve Replacement With MValve Dock and Lotus (DOCK 1)

Mitral Valve Replacement With the MValve Dock and A Percutaneous Transcatheter Heart Valve

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.

Study Overview

• Status: Unknown
• Conditions: Mitral Valve Regurgitation
• Intervention / Treatment: Device: mitral valve replacement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sau Paulo, Brazil
    • Dante Pazzenese Institute of Cardiology
• France
  • Toulouse, France
    • Clinique Pasteur
• Germany
  • Bonn, Germany
    • University of Bonn - Medizinische Klinik und Poliklinik II
• Poland
  • Poznan, Poland
    • University of Poznan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Valve Replacement; Mitral valve replacement	Device: mitral valve replacement; transcatheter mitral valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite serious adverse cardiac events and stroke	death, myocardial infarction, stroke, repeat surgery	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mitral regurgitation grade	1 year

Collaborators and Investigators

• Sponsor: MValve Technologies Ltd

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Estimate): March 25, 2016
• Last Update Submitted That Met QC Criteria: March 21, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: CIP 01-2015