Symptomatic Aortic Stenosis
Conditions
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.
Interventions
DEVICECoreValve 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
Sponsors
Medtronic
Medtronic Cardiovascular
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
Countries
India
Outcome results
None listed