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

RECRUITINGN/ASponsored by Medtronic Cardiovascular
Actively Recruiting
PhaseN/A
SponsorMedtronic Cardiovascular
Started2017-10-23
Est. completion2027-05-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations78 sites
View on ClinicalTrials.gov →

NCT03242642

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Heart DiseaseMitral Valve Regurgitation

Locations78 sites

University of Alabama Birmingham (UAB) Hospital
Birmingham, Alabama, 35233
Marissa Waite205-659-5660mwaite@uabmc.edu
Abrazo Heart Hospital
Phoenix, Arizona, 85018
Jessica Byrne602-952-0002jessica.byrne@abrazohealth.com
Scripps Memorial Hospital
La Jolla, California, 92037
John Gil-Flamer858-824-5238gil-flamer.john@scrippshealth.org
PIH Health Good Samaritan Hospital
Los Angeles, California, 90017
Xochitl Quintero213-977-2121xochitl.quintero@pihhealth.org
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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