Sorin Universal REgistry on Aortic Valve Replacement

Recruiting

• Conditions: I35.0; I35.1; Aortic (valve) stenosis; Aortic (valve) insufficiency

• Registration Number: DRKS00015681
• Lead Sponsor: Sorin Group Italia S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

All patients having received a Sorin Group aortic valve device in accordance with the IFU can be included in the registry. Other than the indication and the contra-indications specified in each IFU, there are no specific inclusion and exclusion criteria since this registry has the aim to include all patients following real life”/standard of care practices at participating centers. All patients must provide written or oral informed consent to participate in the registry following the local regulations.

Exclusion Criteria

Any contra indication(s) for valve Implantation.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is to evaluate the composite rate of site reported valve related major adverse events (MAE) defined as death, stroke and/or re-intervention (involving surgery or any other invasive therapy) at 5 years follow-up.

Secondary Outcome Measures

Name	Time	Method
- Multiple procedural and hospital discharge parameters such as, but not limited to, successful implant, cross clamp time, intensive care unit and total length of hospital stay.<br>- The clinical success defined as a successful valve implantation without MAE at hospital discharge.<br>- The improvement of clinical status defined as an improvement of at least one scale of the New York Heart Association (NYHA) classification between pre-procedure and annually throughout the duration of the registry.<br>- Available echocardiographic/hemodynamic data throughout the duration of the registry.<br>- All site reported MAE rates during the duration of the registry.<br>- The composite rate of site reported valve-related MAE annually through a 4-year follow-up, and 7 and 10-year follow-up in selected centers only.<br>- Other site reported valve-related SAE such as, but not limited to, bleeding, thromboembolism, valve thrombosis, endocarditis, non structural dysfunction, structural valve deterioration