Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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.

NCT03242642

RecruitingNA

Sponsor: Medtronic Cardiovascular

Conditions: Mitral Valve Regurgitation

Interventions: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR), Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

Countries: United States, Canada, Denmark

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (85)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Mountain View, California, United States
  • San Francisco, California, United States
  • Stanford, California, United States
  • Thousand Oaks, California, United States
  • Hartford, Connecticut, United States
  • New Haven, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Atlantis, Florida, United States
  • Clearwater, Florida, United States
  • Fort Myers, Florida, United States
  • Gainesville, Florida, United States
  • Jacksonville, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Des Moines, Iowa, United States
  • Kansas City, Kansas, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • + 55 more on CT.gov