Sorin Universal REgistry on Aortic Valve Replacement

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02679404
Study type	Observational
Source	Corcym S.r.l
Contact
Status	Terminated
Phase
Start date	May 2015
Completion date	March 2021

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Sorin Universal REgistry on Aortic Valve Replacement — SURE-AVR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms