Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
APOLLO
1 other identifier
interventional
1,056
3 countries
85
Brief Summary
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
85 active sites
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
August 3, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedStudy Start
First participant enrolled
October 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2036
May 5, 2026
May 1, 2026
9.6 years
August 3, 2017
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Cohort
Composite of all-cause mortality or heart failure hospitalization
1 year
MAC Cohort
All-cause mortality
1 year
Secondary Outcomes (6)
All-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding
30 days or hospital discharge (whichever is later)
Degree of mitral regurgitation
6 months
Quality of Life Improvement
3 months (KCCQ)
Change in New York Heart Association Class
30 days
Echocardiographic assessments of degree mitral valve regurgitation
1 year
- +1 more secondary outcomes
Study Arms (2)
Primary Cohort- TMVR
EXPERIMENTALTreatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Mitral Annular Calcification -TMVR
EXPERIMENTALTreatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Interventions
mitral valve replacement
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
University of Alabama Birmingham (UAB) Hospital
Birmingham, Alabama, 35233, United States
Abrazo Heart Hospital
Phoenix, Arizona, 85018, United States
Scripps Memorial Hospital
La Jolla, California, 92037, United States
PIH Health Good Samaritan Hospital
Los Angeles, California, 90017, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Keck Hospital of the University of Southern California, USC
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
El Camino Hospital
Mountain View, California, 94040, United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94118-3100, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360-1847, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
JFK Medical Center
Atlantis, Florida, 33462, United States
Morton Plant
Clearwater, Florida, 33756, United States
HealthPark Medical Center
Fort Myers, Florida, 33908, United States
North Florida Regional Medical Center
Gainesville, Florida, 32605, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, 32207, United States
University of South Florida Health
Tampa, Florida, 33606, United States
Emory University
Atlanta, Georgia, 30308, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
MercyOne Des Moines Medical Center
Des Moines, Iowa, 50314, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Henry Ford Saint John Hospital
Detroit, Michigan, 48236, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, 55455, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110-1003, United States
Providence St Patrick
Missoula, Montana, 59802-4008, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Northwell Health North Shore University Hospital
Manhasset, New York, 11030, United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
NYU Langone Medical Center
New York, New York, 10016, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
New York-Presbyterian Hospital Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
New York, New York, 10467-2401, United States
Saint Francis Hospital
Roslyn, New York, 11576, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Christ Hospital
Cincinnati, Ohio, 45219-2906, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Oregon Health & Science University Hospital
Portland, Oregon, 97239, United States
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, 17101, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Heart Hospital of Austin
Austin, Texas, 78756, United States
Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75246, United States
CHI Saint Luke's Health-Baylor Saint Luke's Medical Center
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
Methodist Hospital
San Antonio, Texas, 78229, United States
The University of Vermont Medical Center
Burlington, Vermont, 05401-1473, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Fairfax, Virginia, 22042, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507-1904, United States
Saint Mary's Hospital/Bon Secours
Richmond, Virginia, 23226, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
Winchester Medical Center
Winchester, Virginia, 22601, United States
The Swedish Medical Center Cherry Hill
Seattle, Washington, 98122, United States
University of Washington (UW) Medical Center
Seattle, Washington, 98195, United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, 99204, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7, Canada
Saint Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Saint Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Montreal Heart Insitute
Montreal, Quebec, H1T 1C8, Canada
Glen Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (1)
Tang GHL, Rajagopal V, Sorajja P, Bajwa T, Gooley R, Walton A, Modine T, Ng MK, Williams MR, Zajarias A, Hildick-Smith D, Tchetche D, Spargias K, Rajani R, Bapat VN, De Backer O, Blackman D, McCarthy P, Laine M, Jain R, Martin R, Thaden JJ, Marka NA, Mack M, Adams DH, Leon MB, Reardon MJ. Five-year outcomes of the early-generation Intrepid transapical transcatheter mitral valve replacement system. EuroIntervention. 2026 Feb 2;22(3):e172-e182. doi: 10.4244/EIJ-D-25-01133.
PMID: 41251714DERIVED
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Michael Mack, MD
Baylor Scott & White Hospital
- PRINCIPAL INVESTIGATOR
David Adams, MD
Icahn School of Medicine at Mount Sinai
- PRINCIPAL INVESTIGATOR
Martin Leon, MD
New York Presbyterian Hospital/Columbia University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2017
First Posted
August 8, 2017
Study Start
October 23, 2017
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
September 30, 2036
Last Updated
May 5, 2026
Record last verified: 2026-05