PMS plan is to provide local post marketing surveillance data regarding the safety of Medtronic CoreValveSystem Family
- Conditions
- Health Condition 1: null- Symptomatic Aortic Stenosis
- Registration Number
- CTRI/2016/05/006957
- Lead Sponsor
- India Medtronic Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
NI
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method ILTimepoint: NI