Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Mitral Valve RegurgitationMulti-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
null
Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation 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
Study Location
St. Paul's Hospital
St. Paul's HospitalVancouver, British Columbia
Canada
Contact Study Team
Glen Royal Victoria Hospital
Glen Royal Victoria HospitalMontreal, Quebec
Canada
Contact Study Team
Royal Columbian Hospital
Royal Columbian HospitalNew Westminster, British Columbia
Canada
Contact Study Team
Montreal Heart Insitute
Montreal Heart InsituteMontreal, Quebec
Canada
Contact Study Team
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
Contact Study Team
St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
Contact Study Team
- Study Sponsored By
- Medtronic Cardiovascular
- Participants Required
- More Information
- Study ID:
NCT03242642