Clinical trial NCT03433274: Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Official title: Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Mitral Insufficiency
Mitral Valve Insufficiency
Cardiovascular Diseases
Valve Disease, Heart
Heart Valve Diseases
Functional Mitral Regurgitation
Degenerative Mitral Valve Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 958
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device.

The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.

This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort.

Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.


Eligibility criteria: Inclusion Criteria:

* Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC)
* NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
* The local site heart team determines that the subject has been adequately treated per applicable standards
* Not a member of a vulnerable population

Exclusion Criteria:

* Mitral valvular vegetation or mass
* Left ventricular ejection fraction \< 25%
* Left ventricular end diastolic diameter \> 7.0 cm
* Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material
* Aortic valve disease requiring surgery or transcatheter intervention
* Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention
* Any planned surgical / interventional procedure within 60 day prior to or following subject randomization
* Subject undergoing hemodialysis due to chronic renal failure
* Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation
* Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months

Primary outcomes:
measure: Randomized Cohort
timeFrame: 1 year
measure: Non-repairable Cohort
timeFrame: 1 year
measure: Severe Mitral Annular Calcification (MAC) Cohort
timeFrame: 1 year
measure: Severe MAC Continued Access Protocol (MAC CAP) Cohort
timeFrame: 1 year
Secondary outcomes:
measure: Change from baseline in distance walked, as measured by the 6 Minute Walk Test (6MWT)
timeFrame: 1 year
measure: Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 1 year
measure: Change from baseline in health outcomes, as measured by the EQ-5D
timeFrame: 1 year
measure: • Change from baseline in health outcomes, as measured by the 12-item Short Form Health Survey (SF-12)
timeFrame: 1 year
measure: Change from baseline in New York Heart Association Classification
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Princeton Baptist Medical Center
state: Alabama
city: Birmingham
country: United States
facility: UAB University Hospital
state: Alabama
city: Phoenix
country: United States
facility: Banner-University Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Scottsdale Shea Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Medical Center
state: Arkansas
city: Fresno
country: United States
facility: Fresno Heart Hospital
state: California
city: Los Angeles
country: United States
facility: University of Southern California University Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center, Sacramento
state: California
city: Sacramento
country: United States
facility: University of California - Davis Medical Center
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Stanford
country: United States
facility: Stanford Health Care
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hospital and Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Gainesville
country: United States
facility: Shands at the University of Florida
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Marietta
country: United States
facility: Wellstar Kennestone Hospital
state: Georgia
city: Boise
country: United States
facility: St. Alphonsus Regional Medical Center
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Wichita
country: United States
facility: Cardiovascular Research Institute of Kansas
state: Kansas
city: Balitmore
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Silver Spring
country: United States
facility: Adventist HealthCare White Oak Medical Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Missoula
country: United States
facility: The International Heart Institute of Montana
state: Montana
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College at Albany Medical Center
state: New York
city: Bay Shore
country: United States
facility: South Shore University Hospital
state: New York
city: Buffalo
country: United States
facility: Buffalo General Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital/ Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Asheville
country: United States
facility: Mission Health & Hospitals
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Research Institute
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute at Utica
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart & Vascular Institute
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital - ASRI
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Austin
country: United States
facility: Cardiothoracic & Vascular Surgeons
state: Texas
city: Dallas
country: United States
facility: Baylor Scott & White Heart and Vascular Hospital
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center - Heart & Vascular
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: The Royal Victoria Hospital
state: Quebec
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Institute)
state: Quebec
Study officials:
affiliation: University of Michigan
name: Gorav Ailawadi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Jason Rogers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott Structural Heart
name: Ryan Palmer, PhD
role: STUDY_DIRECTOR
References: