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| ID | Type | Description | Link |
|---|---|---|---|
| REF/2016/04/011112 | Other Identifier | Clinical Trials Registry - India |
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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Group | Patients identified for treatment of symptomatic aortic sten |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eternal Heart Care Centre | Jaipur | Rajasthan | 302020 | India |
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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 |