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

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Covidien

Status

Terminated

Conditions

Symptomatic Aortic Stenosis

Treatments

Device: CoreValve System Family

Study type

Observational

Funder types

Industry

Identifiers

NCT02759237
Version 1.0 17 February 2016
REF/2016/04/011112 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

3 participants in 1 patient group

Patient Group
Description:
Patients identified for treatment of symptomatic aortic sten
Treatment:
Device: CoreValve System Family

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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