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

NCT02759237 | Terminated

• 2 other identifiers: Version 1.0 17 February 2016REF/2016/04/011112
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Symptomatic Aortic Stenosis

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (1)

Patient Group

Patients identified for treatment of symptomatic aortic sten

Device: CoreValve System Family

Interventions

CoreValve System Family 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

Also known as: Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family)

Patient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients identified for treatment of symptomatic aortic stenosis (AS), necessitating The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) as part of standard of care, in accordance with the product label indications (Instructions for Use), contraindications, and warnings

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Medtronic Cardiovascular: lead
• Medtronic: collaborator

Study Sites (1)

Eternal Heart Care Centre

Jaipur, Rajasthan, 302020, India

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 3, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)