Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-31 @ 3:23 PM
Study NCT ID:
NCT02679404
Status:
TERMINATED
Last Update Posted:
2024-03-06
First Post:
2016-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorin Universal REgistry on Aortic Valve Replacement
Sponsor:
Corcym S.r.l
Organization:
Study Overview
Official Title:
Sorin Universal REgistry on Aortic Valve Replacement
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Less data return than expected. The new Medical Device Regulation (MDR) implementation prompted the Sponsor to set up a broader scope post-market registry for all Corcym cardiovascular products (MANTRA).
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SURE-AVR
Brief Summary:
Multi-center, International, Prospective, Non comparative, Non randomized, Open label.
5,000 patients to be enrolled approximately worldwide.
The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU).
This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.
5,000 patients to be enrolled approximately worldwide.
The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU).
This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.
Detailed Description:
SURE-AVR objective is to collect post market safety and performance data collected along the procedure and the relevant follow-up with Sorin Group aortic valve devices in accordance with the IFU to further evidence the safety and efficacy in a post-approval environment. All current and future Sorin Group aortic valve devices that have obtained CE-mark or other local regulatory and/or commercial approvals may be included in the registry. During the duration of the registry,other aortic valve replacement products or current devices might receive modifications and might become commercial available. This registry allows extensions for the inclusion of new products.
This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry following the local applicable regulations.
The data collection shall be performed as per the local standard of care and without exposing the patient to any additional risk to the treatment (s)he would normally receive.
The registry is an open-ended project:
* Inclusions phase: open-ended
* Follow-up phase: annually throughout 5 years (7 and 10 years are optional).
The study shall be completed after the 10-year follow-up of the last patient.
This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry following the local applicable regulations.
The data collection shall be performed as per the local standard of care and without exposing the patient to any additional risk to the treatment (s)he would normally receive.
The registry is an open-ended project:
* Inclusions phase: open-ended
* Follow-up phase: annually throughout 5 years (7 and 10 years are optional).
The study shall be completed after the 10-year follow-up of the last patient.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: