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

Medtronic Cardiovascular1,056 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,056

Conditions

Mitral Valve Regurgitation

Interventions

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)DEVICE

mitral valve replacement

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (85)

Outcomes

Primary Outcomes

Primary Cohort

Composite of all-cause mortality or heart failure hospitalization

Time frame: 1 year

MAC Cohort

All-cause mortality

Time frame: 1 year

Secondary Outcomes

All-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding

Composite

Time frame: 30 days or hospital discharge (whichever is later)

Degree of mitral regurgitation

measured by echocardiography

Time frame: 6 months

Quality of Life Improvement

measured by KCCQ

Time frame: 3 months (KCCQ)

Change in New York Heart Association Class

change in NYHA Class

Time frame: 30 days

Echocardiographic assessments of degree mitral valve regurgitation

measured by echocardiography

Time frame: 1 year

Cardiovascular hospitalizations

cardiovascular hospitalizations

Time frame: 1 year

Central Contacts

Megan Wilder Fredrickson

CONTACT

612-469-1749 rs.tmvrpivotaltrial@medtronic.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

University of Alabama Birmingham (UAB) Hospital

Birmingham, Alabama, United States

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Abrazo Heart Hospital

Phoenix, Arizona, United States

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Scripps Memorial Hospital

La Jolla, California, United States

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PIH Health Good Samaritan Hospital

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Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

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Keck Hospital of the University of Southern California, USC

Los Angeles, California, United States

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Cedars Sinai Medical Center

Los Angeles, California, United States

RECRUITING

El Camino Hospital

Mountain View, California, United States

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Kaiser Permanente San Francisco Medical Center

San Francisco, California, United States

RECRUITING

Stanford Hospital and Clinics

Stanford, California, United States

RECRUITING

...and 75 more locations