Health Condition 1: null- Symptomatic Aortic Stenosis
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients with symptomatic heart disease due to severe native calcific aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure and with anatomy appropriate for the 23, 26, 29 or 31 mm valve system who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy. Indications and contraindications are provided in the product Instructions for Use. Subject is scheduled to receive transcatheter aortic valve Subject is 18 years of age or older The patient or his/her Legally Authorized Representative (LAR) has been informed about the nature of the PMS and the Informed consent for both Audio Visual (AV) recording and for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements in India
Exclusion criteria
Exclusion criteria: NIL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main focus of this PMS will be to generate additional information and report on all major adverse events up to 30 days from the day of implant procedureTimepoint: The main focus of this PMS will be to generate additional information and report on all major adverse events up to 30 days from the day of implant procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactVinay Rajan
India Medtronic Pvt Ltd
Outcome results
None listed