RecruitingNot ApplicableNCT03242642

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

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

Sponsor

Medtronic Cardiovascular

Enrollment

1,056 participants

Start Date

Oct 23, 2017

Study Type

INTERVENTIONAL

Conditions

Mitral Valve Regurgitation

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the Medtronic Intrepid system — a transcatheter (minimally invasive, catheter-based) mitral valve replacement — in patients with severe mitral valve regurgitation (a leaking heart valve) who are not suitable for conventional surgery or approved repair devices. You may be eligible if: - You are 18 years of age or older - You have moderate-to-severe or severe symptomatic mitral valve regurgitation - A multidisciplinary heart team has determined you are not suitable for standard surgical repair or approved transcatheter repair You may NOT be eligible if: - You have previously had a transcatheter mitral valve device implanted - You have anatomical features that make the procedure unsafe - You have severe calcification in the mitral valve ring - Your heart pumping function is very poor (ejection fraction below 25%) - You need emergency or urgent heart surgery - You are in a state of hemodynamic instability (cardiovascular collapse) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMedtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

mitral valve replacement

DEVICEMedtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

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

Locations(85)

University of Alabama Birmingham (UAB) Hospital

Birmingham, Alabama, United States

Abrazo Heart Hospital

Phoenix, Arizona, United States

Scripps Memorial Hospital

La Jolla, California, United States

PIH Health Good Samaritan Hospital

Los Angeles, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Keck Hospital of the University of Southern California, USC

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

El Camino Hospital

Mountain View, California, United States

Kaiser Permanente San Francisco Medical Center

San Francisco, California, United States

Stanford Hospital and Clinics

Stanford, California, United States

Los Robles Regional Medical Center

Thousand Oaks, California, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

JFK Medical Center

Atlantis, Florida, United States

Morton Plant

Clearwater, Florida, United States

HealthPark Medical Center

Fort Myers, Florida, United States

North Florida Regional Medical Center

Gainesville, Florida, United States

Baptist Medical Center Jacksonville

Jacksonville, Florida, United States

University of South Florida Health

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

MercyOne Des Moines Medical Center

Des Moines, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Henry Ford Saint John Hospital

Detroit, Michigan, United States

Corewell Health

Grand Rapids, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Providence St Patrick

Missoula, Montana, United States

Morristown Medical Center

Morristown, New Jersey, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Northwell Health North Shore University Hospital

Manhasset, New York, United States

NYU Langone Hospital - Long Island

Mineola, New York, United States

NYU Langone Medical Center

New York, New York, United States

The Mount Sinai Hospital

New York, New York, United States

New York-Presbyterian Hospital Columbia University Medical Center

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

Saint Francis Hospital

Roslyn, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Oregon Health & Science University Hospital

Portland, Oregon, United States

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, United States

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Heart Hospital of Austin

Austin, Texas, United States

Texas Health Presbyterian Hospital Dallas

Dallas, Texas, United States

Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Dallas, Texas, 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

The Heart Hospital Baylor Plano

Plano, Texas, United States

Methodist Hospital

San Antonio, Texas, United States

The University of Vermont Medical Center

Burlington, Vermont, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Inova Fairfax Hospital

Fairfax, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Saint Mary's Hospital/Bon Secours

Richmond, Virginia, United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Winchester Medical Center

Winchester, Virginia, United States

The Swedish Medical Center Cherry Hill

Seattle, Washington, United States

University of Washington (UW) Medical Center

Seattle, Washington, United States

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Saint Paul's Hospital

Vancouver, British Columbia, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Saint Michael's Hospital

Toronto, Ontario, Canada

Montreal Heart Insitute

Montreal, Quebec, Canada

Glen Royal Victoria Hospital

Montreal, Quebec, Canada

Rigshospitalet

Copenhagen, Denmark

View Full Details on ClinicalTrials.gov

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NCT03242642

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