The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS)

Study Overview
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Brief Summary
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The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) has been demonstrated to be safe and effective for high through extreme risk patients with symptomatic severe native aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure. Per DCGI systematic post marketing surveillance requirement, the purpose of this PMS plan is to provide local post marketing surveillance data regarding the safety of Medtronic CoreValve System Family

Detailed Description
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The objective of this PMS will be to monitor and gather data on the safety of The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) in the approved intended use. 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.

Official Title
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The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS)

Conditions
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Symptomatic Aortic Stenosis

Intervention / Treatment
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* Device: CoreValve System Family


Participation Criteria
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Eligibility Criteria
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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: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient Group<br>Patients identified for treatment of symptomatic aortic sten | Device: CoreValve System Family<br>* Bioprosthesis: Transcatheter Aortic Valve Implant (TAV - Heart Valve) -Different Models/Sizes of CoreValve/CoreValve Evolut R. Delivery Catheter System: ACCUTRAK & EnVeo R - Used to facilitate the placement of the bioprosthesis within the annulus. Loading System: Compression Loading System & EnVeo R Loading System - Used to load the TAV onto the delivery system<br>* Other names: Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety outcomes: all major adverse events | This is a surveillance plan designed to collect and report safety outcomes; hence there are no additional clinical endpoints identified. 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. | 30 days post procedure | 
| MACCE | Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure | 30 day post procedure | 
| Acute kidney Injury | Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure | 30 day post procedure | 
| Cardiac tamponade | Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure | 30 days post procedure | 
| Prosthetic valve dysfunction - including moderate or severe aortic regurgitation | Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure | 30 days post procedure | 
| Cardiogenic shock | Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure | 30 days post procedure | 
| Prosthetic valve endocarditis | Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure | 30 days post procedure | 
| Life-threatening, disabling or major bleeding | Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure | 30 days post procedure | 
| Major vascular complication | Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure | 30 days post procedure | 
| Cardiac perforation | Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure | 30 days post procedure | 
| Valve malpositioning | Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure | 30 days post procedure | 
| Thrombosis and coronary occlusion | Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure | 30 days post procedure |