CTRI/2016/05/006957
Active, not recruiting
Phase 4
The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS) - CoreValveTM India (PMS)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Symptomatic Aortic Stenosis
- Sponsor
- India Medtronic Pvt Ltd
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- Not provided
Outcomes
Primary Outcomes
Not specified
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