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

Medtronic Cardiovascular1 site in 1 country3 target enrollmentFebruary 2016

ConditionsSymptomatic Aortic Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Symptomatic Aortic Stenosis
Sponsor: Medtronic Cardiovascular
Enrollment: 3
Locations: 1
Primary Endpoint: Safety outcomes: all major adverse events
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

May 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medtronic Cardiovascular

Responsible Party

Sponsor

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

Safety outcomes: all major adverse events

Time Frame: 30 days post procedure

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.

Cardiogenic shock

Time Frame: 30 days post procedure