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

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

Study Overview

• Status: Terminated
• Conditions: Symptomatic Aortic Stenosis
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• India
  • Rajasthan
    • Jaipur, Rajasthan, India, 302020
      • Eternal Heart Care Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patient Group; Patients identified for treatment of symptomatic aortic sten

Device: 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; Other Names: Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: Version 1.0 17 February 2016; REF/2016/04/011112 (Other Identifier: Clinical Trials Registry - India)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO