Health Trials

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

ConditionMitral Valve Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronic Cardiovascular

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

prior transcatheter mitral valve procedure with device currently implanted

anatomic contraindications

prohibitive mitral annular calcification

left ventricular ejection fraction <25%

Trial design

Treatments tested in this trial

  • Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
  • Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

Treatment groups

1,056 Participants
are divided into 2 treatment groups

Locations

85
Canada
Royal Columbian HospitalV3L 3W7, New WestminsterBritish Columbia, Canada
Saint Paul's HospitalV6Z 1Y6, VancouverBritish Columbia, Canada
Saint Michael's HospitalM5B 1W8, TorontoOntario, Canada
Sunnybrook Health Sciences CentreM4N 3M5, TorontoOntario, Canada

Sponsors and collaborators

Medtronic Cardiovascular

Lead sponsor

Source ClinicalTrials.gov