Mitral Valve Regurgitation Clinical Trial
— APOLLOOfficial title:
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
| Status | Recruiting |
| Enrollment | 1156 |
| Est. completion date | September 30, 2035 |
| Est. primary completion date | October 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Glen Royal Victoria Hospital | Montreal | Quebec |
| Canada | Montreal Heart Insitute | Montreal | Quebec |
| Canada | Royal Columbian Hospital | New Westminster | British Columbia |
| Canada | St. Michael's Hospital | Toronto | Ontario |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| Canada | St. Paul's Hospital | Vancouver | British Columbia |
| Denmark | Rigshospitalet | Copenhagen | |
| United States | University of Michigan Health System | Ann Arbor | Michigan |
| United States | Emory University | Atlanta | Georgia |
| United States | Piedmont Atlanta Hospital | Atlanta | Georgia |
| United States | JFK Medical Center | Atlantis | Florida |
| United States | Heart Hospital of Austin | Austin | Texas |
| United States | The Johns Hopkins Hospital | Baltimore | Maryland |
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| United States | University of Alabama Birmingham (UAB) | Birmingham | Alabama |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | The University of Vermont Medical Center | Burlington | Vermont |
| United States | University of Virginia Medical Center | Charlottesville | Virginia |
| United States | Northwestern Memorial Hospital | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | The Christ Hospital | Cincinnati | Ohio |
| United States | Morton Plant | Clearwater | Florida |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | OhioHealth Riverside Methodist Hospital | Columbus | Ohio |
| United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
| United States | Baylor Jack and Jane Hamilton Heart and Vascular Hospital | Dallas | Texas |
| United States | Texas Health Presbyterian Hospital Dallas | Dallas | Texas |
| United States | Mercy Medical Center | Des Moines | Iowa |
| United States | Ascension St. John Hospital | Detroit | Michigan |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Inova Fairfax Hospital | Fairfax | Virginia |
| United States | HealthPark Medical Center | Fort Myers | Florida |
| United States | North Florida Regional Medical Center | Gainesville | Florida |
| United States | Spectrum Health Hospital | Grand Rapids | Michigan |
| United States | UPMC Pinnacle Harrisburg Campus | Harrisburg | Pennsylvania |
| United States | Hartford Hospital | Hartford | Connecticut |
| United States | CHI Saint Luke's Health-Baylor Saint Luke's Medical Center | Houston | Texas |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| United States | Baptist Medical Center Jacksonville | Jacksonville | Florida |
| United States | The University of Kansas Hospital | Kansas City | Kansas |
| United States | Scripps Memorial Hospital | La Jolla | California |
| United States | Cedars Sinai Medical Center | Los Angeles | California |
| United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
| United States | Keck Hospital of the University of Southern California | Los Angeles | California |
| United States | PIH Health Good Samaritan Hospital | Los Angeles | California |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin |
| United States | NYU Langone Hospital - Long Island | Mineola | New York |
| United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
| United States | University of Minnesota Medical Center Fairview | Minneapolis | Minnesota |
| United States | Providence St Patrick | Missoula | Montana |
| United States | Morristown Memorial Hospital | Morristown | New Jersey |
| United States | El Camino | Mountain View | California |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Jersey Shore University Medical Center | Neptune | New Jersey |
| United States | Yale New Haven Hospital | New Haven | Connecticut |
| United States | Columbia University Medical Center/NYPH | New York | New York |
| United States | Montefiore Medical Center | New York | New York |
| United States | NYU Langone Medical Center | New York | New York |
| United States | The Mount Sinai Hospital | New York | New York |
| United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma |
| United States | Abrazo Heart Hospital | Phoenix | Arizona |
| United States | University of Pittsburgh Medical Center UPMC Presbyterian | Pittsburgh | Pennsylvania |
| United States | Baylor Scott & White Health (The Heart Hospital Baylor Plano) | Plano | Texas |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Providence Saint Vincent Medical Center | Portland | Oregon |
| United States | Saint Mary's Hospital/Bon Secours | Richmond | Virginia |
| United States | Carilion Roanoke Memorial Hospital | Roanoke | Virginia |
| United States | Saint Francis Hospital | Roslyn | New York |
| United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
| United States | Methodist Hospital | San Antonio | Texas |
| United States | Kaiser Permanente San Francisco Medical Center | San Francisco | California |
| United States | The Swedish Medical Center Cherry Hill | Seattle | Washington |
| United States | University of Washington | Seattle | Washington |
| United States | Providence Sacred Heart Medical Center & Children's Hospital | Spokane | Washington |
| United States | Stanford Hospital and Clinics | Stanford | California |
| United States | University of South Florida | Tampa | Florida |
| United States | Los Robles Regional Medical Center | Thousand Oaks | California |
| United States | MedStar Washington Hospital Center | Washington | District of Columbia |
| United States | Winchester Medical Center | Winchester | Virginia |
| United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Cardiovascular |
United States, Canada, Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary Cohort | all-cause mortality or heart failure hospitalization post-30 days or KCCQ improvement < 10 composite | 1 year | |
| Primary | MAC Cohort | all-cause mortality | 1 year | |
| Secondary | all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding | Composite | 30 days or hospital discharge (whichever is later) | |
| Secondary | Change in New York Heart Association Class | change in NYHA Class | 30 days | |
| Secondary | Quality of Life Improvement | measured by SF-12 and KCCQ | 30 days (SF-12) and 3 months (KCCQ) | |
| Secondary | Echocardiographic assessments of degree mitral valve regurgitation | measured by echocardiography | 1 year | |
| Secondary | Cardiovascular hospitalizations | cardiovascular hospitalizations | 1 year |
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