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.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
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
Lieu de l'étude
St. Paul's Hospital
St. Paul's HospitalVancouver, British Columbia
Canada
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Glen Royal Victoria Hospital
Glen Royal Victoria HospitalMontreal, Quebec
Canada
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Royal Columbian Hospital
Royal Columbian HospitalNew Westminster, British Columbia
Canada
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Montreal Heart Insitute
Montreal Heart InsituteMontreal, Quebec
Canada
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Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
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St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
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- Étude parrainée par
- Medtronic Cardiovascular
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT03242642