NCT02719912

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

March 21, 2016

Last Update Submit

March 21, 2016

Conditions

Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Composite serious adverse cardiac events and stroke

    death, myocardial infarction, stroke, repeat surgery

    30 days

Secondary Outcomes (1)

  • Mitral regurgitation grade

    1 year

Study Arms (1)

Valve Replacement

EXPERIMENTAL

Mitral valve replacement

Device: mitral valve replacement

Interventions

mitral valve replacementDEVICE

transcatheter mitral valve replacement

Valve Replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dante Pazzenese Institute of Cardiology

Sau Paulo, Brazil

Location

Clinique Pasteur

Toulouse, France

Location

University of Bonn - Medizinische Klinik und Poliklinik II

Bonn, Germany

Location

University of Poznan

Poznan, Poland

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 25, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2018

Last Updated

March 25, 2016

Record last verified: 2016-03

Locations

DE(1)FR(1)BR(1)PL(1)