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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-05-31

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

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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.

Conditions

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Symptomatic Aortic Stenosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient Group

Patients identified for treatment of symptomatic aortic sten

CoreValve System Family

Intervention Type DEVICE

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

Interventions

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CoreValve System Family

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

Intervention Type DEVICE

Other Intervention Names

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Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family)

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