Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Launched by MEDTRONIC CARDIOVASCULAR · Aug 3, 2017
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new device called the Medtronic Intrepid™ that is designed to help patients with a serious heart condition known as mitral valve regurgitation. In this condition, the heart’s mitral valve does not close properly, causing blood to flow backward and leading to symptoms like shortness of breath and fatigue. The trial aims to see how well this device works for patients who have moderate to severe symptoms and cannot undergo other types of treatments for their condition.
To be part of this trial, participants generally need to be between 65 and 74 years old and have been deemed unsuitable for other existing heart valve treatments by a specialized heart team. If they join the study, they will receive the new device and be monitored for its effectiveness and safety. It's important to note that individuals who have had a similar procedure before or have certain heart conditions may not be eligible. The trial is currently recruiting participants from various locations, and everyone who qualifies will receive the study device.
Gender
ALL
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
About Medtronic Cardiovascular
Medtronic Cardiovascular is a leading global healthcare technology company dedicated to transforming patient care through innovative medical solutions. With a focus on cardiovascular health, Medtronic develops advanced devices and therapies that address a wide range of heart and vascular conditions. Committed to clinical excellence and patient outcomes, the company conducts rigorous clinical trials to evaluate the safety and efficacy of its products, ensuring they meet the highest regulatory standards. Medtronic Cardiovascular strives to enhance the quality of life for patients worldwide while advancing the field of cardiovascular medicine through research and development.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Durham, North Carolina, United States
Seattle, Washington, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Copenhagen, , Denmark
Chicago, Illinois, United States
Manhasset, New York, United States
Des Moines, Iowa, United States
Chicago, Illinois, United States
Toronto, Ontario, Canada
Atlantis, Florida, United States
Grand Rapids, Michigan, United States
Houston, Texas, United States
Houston, Texas, United States
Wynnewood, Pennsylvania, United States
Hartford, Connecticut, United States
Nashville, Tennessee, United States
Washington, District Of Columbia, United States
Portland, Oregon, United States
Baltimore, Maryland, United States
Morristown, New Jersey, United States
Mineola, New York, United States
Portland, Oregon, United States
Ann Arbor, Michigan, United States
Toronto, Ontario, Canada
Morristown, New Jersey, United States
Roanoke, Virginia, United States
Minneapolis, Minnesota, United States
Austin, Texas, United States
Atlanta, Georgia, United States
Roslyn, New York, United States
Oklahoma City, Oklahoma, United States
Vancouver, British Columbia, Canada
Los Angeles, California, United States
Atlanta, Georgia, United States
Los Angeles, California, United States
Tampa, Florida, United States
Charlottesville, Virginia, United States
Stanford, California, United States
Dallas, Texas, United States
Winchester, Virginia, United States
New York, New York, United States
La Jolla, California, United States
New Westminster, British Columbia, Canada
San Antonio, Texas, United States
New York, New York, United States
Minneapolis, Minnesota, United States
Neptune, New Jersey, United States
Milwaukee, Wisconsin, United States
New Haven, Connecticut, United States
Gainesville, Florida, United States
Norfolk, Virginia, United States
New York, New York, United States
Plano, Texas, United States
Fairfax, Virginia, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Columbus, Ohio, United States
Jacksonville, Florida, United States
Cincinnati, Ohio, United States
Spokane, Washington, United States
Kansas City, Kansas, United States
Dallas, Texas, United States
Columbus, Ohio, United States
Montreal, Quebec, Canada
New York, New York, United States
Detroit, Michigan, United States
Fort Myers, Florida, United States
Los Angeles, California, United States
Phoenix, Arizona, United States
San Francisco, California, United States
Clearwater, Florida, United States
Saint Louis, Missouri, United States
Harrisburg, Pennsylvania, United States
Houston, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Burlington, Vermont, United States
Los Angeles, California, United States
Mineola, New York, United States
Montreal, Quebec, Canada
Grand Rapids, Michigan, United States
Missoula, Montana, United States
Minneapolis, Minnesota, United States
Plano, Texas, United States
Thousand Oaks, California, United States
Montreal, Quebec, Canada
Mountain View, California, United States
Birmingham, Alabama, United States
Morristown, New Jersey, United States
New York, New York, United States
Detroit, Michigan, United States
Patients applied
Trial Officials
Michael Mack, MD
Study Chair
Baylor Scott & White Hospital
David Adams, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Martin Leon, MD
Principal Investigator
New York Presbyterian Hospital/Columbia University Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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