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

Terminated

• Conditions: Symptomatic Aortic Stenosis
• Interventions: Device: CoreValve System Family

• Registration Number: NCT02759237
• Lead Sponsor: Medtronic Cardiovascular

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-03
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-12
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient Group	CoreValve System Family	Patients identified for treatment of symptomatic aortic sten

Primary Outcome Measures

Name	Time	Method
Safety outcomes: all major adverse events	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	30 days post procedure	Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Prosthetic valve endocarditis	30 days post procedure	Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Life-threatening, disabling or major bleeding	30 days post procedure	Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Valve malpositioning	30 days post procedure	Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
MACCE	30 day post procedure	Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Major vascular complication	30 days post procedure	Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Thrombosis and coronary occlusion	30 days post procedure	Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Acute kidney Injury	30 day post procedure	Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Cardiac perforation	30 days post procedure	Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Cardiac tamponade	30 days post procedure	Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure
Prosthetic valve dysfunction - including moderate or severe aortic regurgitation	30 days post procedure	Safety endpoints will be reported as Kaplan-Meier rates which are probabilities of having an event at 30 days post-procedure

Trial Locations

Locations (1)

Eternal Heart Care Centre; 🇮🇳 Jaipur, Rajasthan, India