Mitral Valve Replacement With MValve Dock and Lotus

Mitral Valve Regurgitation Clinical Trial

— DOCK 1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02719912
• Other study ID #: CIP 01-2015
• Status: Not yet recruiting
• Phase: N/A
• First received: March 21, 2016
• Last updated: March 21, 2016
• Start date: June 2016
• Est. completion date: July 2018

Study information

• Verified date: March 2016
• Source: MValve Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence nationale de security du medicament (ANSM)Poland: Ministry of HealthGermany: Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM)Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• mitral valve replacement
transcatheter mitral valve replacement

Locations

Country	Name	City	State
Brazil	Dante Pazzenese Institute of Cardiology	Sau Paulo
France	Clinique Pasteur	Toulouse
Germany	University of Bonn - Medizinische Klinik und Poliklinik II	Bonn
Poland	University of Poznan	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
MValve Technologies Ltd

Countries where clinical trial is conducted

Brazil,  France,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite serious adverse cardiac events and stroke	death, myocardial infarction, stroke, repeat surgery	30 days	Yes
Secondary	Mitral regurgitation grade		1 year	Yes