Clinical trial NCT02718001: Edwards EVOQUE Eos MISCEND Study
Official title: Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
Keywords: Mitral
Regurgitation
Insufficiency
Degenerative
Functional
Primary
Secondary
Organic
Transcatheter
TMVR
TMVI
Heart Valve
Mitral Valve
Transseptal
Trans-Septal
Transeptal
Severe
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-03-24
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Clinically significant, symptomatic mitral regurgitation
* High risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Patient is inoperable

Primary outcomes:
measure: Composite of major adverse events
timeFrame: 30 days
Secondary outcomes:
measure: NYHA functional class
timeFrame: 30 days, 6 Months, 12 Months, annual for five years
measure: Six minute walk test
timeFrame: 30 days, 6 Months, 12 Months, annual for five years
measure: Reduction in MR grade
timeFrame: 30 days, 6 Months, 12 Months, annual for five years
measure: Device Success
timeFrame: Immediately after procedure
measure: Procedural Success
timeFrame: Discharge or 7 days post-procedure, whichever occurs first
measure: Clinical Success
timeFrame: 30 days
Other outcomes:
Locations:
city: Burlingame
country: United States
facility: Sutter Mills-Peninsula
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco
state: California
city: Atlanta
country: United States
facility: Emory University Hospital/Emory University Hospital Midtown
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval
city: Toronto
country: Canada
facility: St. Michael's Hospital
Study officials:
affiliation: Cedars-Sinai Medical Center, Los Angeles, CA
name: Rajendra Makkar, MD
role: PRINCIPAL_INVESTIGATOR
References: