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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02719912
Recruitment Status : Unknown
Verified March 2016 by MValve Technologies Ltd.
Recruitment status was:  Not yet recruiting
First Posted : March 25, 2016
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
MValve Technologies Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: mitral valve replacement Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mitral Valve Replacement With the MValve Dock and A Percutaneous Transcatheter Heart Valve
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Valve Replacement
Mitral valve replacement
 Device: mitral valve replacement
transcatheter mitral valve replacement


Outcome Measures
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Primary Outcome Measures :
  1. Composite serious adverse cardiac events and stroke [ Time Frame: 30 days ]
    death, myocardial infarction, stroke, repeat surgery


Secondary Outcome Measures :
  1. Mitral regurgitation grade [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02719912


Locations
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Brazil
Dante Pazzenese Institute of Cardiology
Sau Paulo, Brazil
Contact: Alexander Abizaid, MD         
Contact       aabizaid@uol.com.br   
Principal Investigator: Alexander Abizaid, MD         
France
Clinique Pasteur
Toulouse, France
Contact: Frederic Petit       fpetit@clinique-pasteur.com   
Principal Investigator: Didier Tchetche, MD         
Germany
University of Bonn - Medizinische Klinik und Poliklinik II
Bonn, Germany
Contact: Kaja Twelker, MD       kaja.twelker@ukb.uni-bonn.de   
Principal Investigator: Georg Nickenig, MD         
Poland
University of Poznan
Poznan, Poland
Contact: Maciej Lesiak, MD         
Contact       maciej.lesiak@skpp.edu.pl   
Principal Investigator: Maciej Lesiak, MD         
Sponsors and Collaborators
MValve Technologies Ltd
More Information
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Responsible Party: MValve Technologies Ltd
ClinicalTrials.gov Identifier: NCT02719912    
Other Study ID Numbers: CIP 01-2015
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases