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

Symptomatic Aortic Stenosis Clinical Trial

— CoreValveIndia  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02759237
• Other study ID #: Version 1.0 17 February 2016
• Secondary ID: REF/2016/04/0111
• Status: Terminated
• Phase: N/A
• First received: April 29, 2016
• Last updated: June 12, 2017
• Start date: February 2016
• Est. completion date: May 2017

Study information

• Verified date: June 2017
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Aortic Stenosis

Intervention

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

Locations

Country	Name	City	State
India	Eternal Heart Care Centre	Jaipur	Rajasthan

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiovascular	Medtronic

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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