Edwards EVOQUE Eos MISCEND Study

Mitral Valve Regurgitation (Degenerative or Functional) Clinical Trial

Official title:

Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02718001
• Other study ID #: 2013-05C
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 6, 2015
• Est. completion date: April 30, 2033

Study information

• Verified date: November 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system

Description:

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 123
• Est. completion date: April 30, 2033
• Est. primary completion date: April 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinically significant, symptomatic mitral regurgitation

• High risk for open-heart surgery

• Meets anatomical criteria

Exclusion Criteria:

• Unsuitable anatomy

• Patient is inoperable

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation (Degenerative or Functional)

Intervention

Device:
• Edwards EVOQUE Eos Mitral Valve Replacement System
Replacement of the mitral valve through a transcatheter approach

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval	Québec
Canada	St. Michael's Hospital	Toronto
Canada	St. Paul's Hospital	Vancouver	British Columbia
United States	Emory University Hospital/Emory University Hospital Midtown	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Sutter Mills-Peninsula	Burlingame	California
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center	Houston	Texas
United States	St. Vincent Heart Center	Indianapolis	Indiana
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	St. Francis Hospital	Roslyn	New York
United States	Kaiser Permanente San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of major adverse events	Proportion of patients with major adverse events	30 days
Secondary	NYHA functional class	Number of patients with improvement in NYHA class	30 days, 6 Months, 12 Months, annual for five years
Secondary	Six minute walk test	Increase in distance (m) from baseline	30 days, 6 Months, 12 Months, annual for five years
Secondary	Reduction in MR grade	Number of patients with reduction in MR grade from baseline	30 days, 6 Months, 12 Months, annual for five years
Secondary	Device Success	Proportion of patients with device deployed as intended and delivery system successfully retrieved	Immediately after procedure
Secondary	Procedural Success	Proportion of patients with device success without significant paravalvular leak	Discharge or 7 days post-procedure, whichever occurs first
Secondary	Clinical Success	Proportion of patients with procedural success without major adverse events	30 days