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

Primary Purpose

Mitral Valve Regurgitation

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

mitral valve replacement

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Dante Pazzenese Institute of Cardiology
Clinique Pasteur
University of Bonn - Medizinische Klinik und Poliklinik II
University of Poznan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valve Replacement

Arm Description

Mitral valve replacement

Outcomes

Primary Outcome Measures

Composite serious adverse cardiac events and stroke

death, myocardial infarction, stroke, repeat surgery

Secondary Outcome Measures

Mitral regurgitation grade

Full Information

NCT ID

NCT02719912

First Posted

March 21, 2016

Last Updated

March 21, 2016

Sponsor

MValve Technologies Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02719912

Brief Title

Mitral Valve Replacement With MValve Dock and Lotus

Acronym

DOCK 1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MValve Technologies Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Valve Regurgitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Valve Replacement

Arm Type

Experimental

Arm Description

Mitral valve replacement

Intervention Type

Device

Intervention Name(s)

mitral valve replacement

Intervention Description

transcatheter mitral valve replacement

Primary Outcome Measure Information:

Title

Composite serious adverse cardiac events and stroke

Description

death, myocardial infarction, stroke, repeat surgery

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Mitral regurgitation grade

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Dante Pazzenese Institute of Cardiology

City

Sau Paulo

Country

Brazil

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alexander Abizaid, MD

aabizaid@uol.com.br

First Name & Middle Initial & Last Name & Degree

Alexander Abizaid, MD

Facility Name

Clinique Pasteur

City

Toulouse

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frederic Petit

fpetit@clinique-pasteur.com

First Name & Middle Initial & Last Name & Degree

Didier Tchetche, MD

Facility Name

University of Bonn - Medizinische Klinik und Poliklinik II

City

Bonn

Country

Germany

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaja Twelker, MD

kaja.twelker@ukb.uni-bonn.de

First Name & Middle Initial & Last Name & Degree

Georg Nickenig, MD

Facility Name

University of Poznan

City

Poznan

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maciej Lesiak, MD

maciej.lesiak@skpp.edu.pl

First Name & Middle Initial & Last Name & Degree

Maciej Lesiak, MD

12. IPD Sharing Statement

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Mitral Valve Replacement With MValve Dock and Lotus

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