Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Mitral Valve Regurgitation Clinical Trial

— APOLLO  

Official title:

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03242642
• Other study ID #: MDT17022TMV001
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: September 30, 2035

Study information

• Verified date: March 2024
• Source: Medtronic Cardiovascular
• Contact: Megan Wilder Fredrickson
• Phone: 612-469-1749
• Email: rs.tmvrpivotaltrial[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
mitral valve replacement
• Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

United States,  Canada,  Denmark, 

Outcome

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