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

Not Applicable

Recruiting

• Conditions: Mitral Valve Regurgitation

• Registration Number: NCT03242642
• Lead Sponsor: Medtronic Cardiovascular

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-08
• Study Start: 2017-10-23
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-04
• Primary Completion: 2027-05-30
• Study Completion: 2036-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1056

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Cohort	1 year	Composite of all-cause mortality or heart failure hospitalization
MAC Cohort	1 year	All-cause mortality

Secondary Outcome Measures

Name	Time	Method
All-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding	30 days or hospital discharge (whichever is later)	Composite
Degree of mitral regurgitation	6 months	measured by echocardiography
Quality of Life Improvement	3 months (KCCQ)	measured by KCCQ
Change in New York Heart Association Class	30 days	change in NYHA Class
Echocardiographic assessments of degree mitral valve regurgitation	1 year	measured by echocardiography
Cardiovascular hospitalizations	1 year	cardiovascular hospitalizations

Trial Locations

Locations (85)

University of Alabama Birmingham (UAB); 🇺🇸 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; 🇺🇸 Los Angeles, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

El Camino; 🇺🇸 Mountain View, California, United States

Kaiser Permanente San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

Stanford Hospital and Clinics; 🇺🇸 Stanford, California, United States

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