Clinical trial NCT03242642: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Official title: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Valve Regurgitation
Keywords: Heart disease
valve disease
heart valve disease
mitral regurgitation
cardiovascular disease
mitral insufficiency
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 1056
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe or severe symptomatic mitral regurgitation
* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention

Exclusion Criteria:

* prior transcatheter mitral valve procedure with device currently implanted
* anatomic contraindications
* prohibitive mitral annular calcification
* left ventricular ejection fraction \<25%
* need for emergent or urgent surgery
* hemodynamic instability

Primary outcomes:
measure: Primary Cohort
timeFrame: 1 year
measure: MAC Cohort
timeFrame: 1 year
Secondary outcomes:
measure: All-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding
timeFrame: 30 days or hospital discharge (whichever is later)
measure: Degree of mitral regurgitation
timeFrame: 6 months
measure: Quality of Life Improvement
timeFrame: 3 months (KCCQ)
measure: Change in New York Heart Association Class
timeFrame: 30 days
measure: Echocardiographic assessments of degree mitral valve regurgitation
timeFrame: 1 year
measure: Cardiovascular hospitalizations
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham (UAB)
state: Alabama
city: Phoenix
country: United States
facility: Abrazo Heart Hospital
state: Arizona
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: PIH Health Good Samaritan Hospital
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of the University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Mountain View
country: United States
facility: El Camino
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Clearwater
country: United States
facility: Morton Plant
state: Florida
city: Fort Myers
country: United States
facility: HealthPark Medical Center
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center Jacksonville
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Des Moines
country: United States
facility: Mercy Medical Center
state: Iowa
city: Kansas City
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Saint John Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center - East Bank
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Missoula
country: United States
facility: Providence St Patrick
state: Montana
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Roslyn
country: United States
facility: Saint Francis Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Riverside Methodist Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Providence Saint Vincent Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Harrisburg
country: United States
facility: UPMC Pinnacle Harrisburg Campus
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Presbyterian
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Dallas
country: United States
facility: Texas Health Presbyterian Hospital Dallas
state: Texas
city: Dallas
country: United States
facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: CHI Saint Luke's Health-Baylor Saint Luke's Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White Health (The Heart Hospital Baylor Plano)
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Saint Mary's Hospital/Bon Secours
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Seattle
country: United States
facility: The Swedish Medical Center Cherry Hill
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center & Children's Hospital
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
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: Montreal Heart Insitute
state: Quebec
city: Montreal
country: Canada
facility: Glen Royal Victoria Hospital
state: Quebec
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Baylor Scott & White Hospital
name: Michael Mack, MD
role: STUDY_CHAIR
affiliation: Icahn School of Medicine at Mount Sinai
name: David Adams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Presbyterian Hospital/Columbia University Medical Center
name: Martin Leon, MD
role: PRINCIPAL_INVESTIGATOR
References: