Corcym Mitral, Aortic aNd Tricuspid post-maRket Study in a reAl-world setting

Phase 4

Recruiting

• Conditions: heart valve replacement; heart valve disease; 10046973

• Registration Number: NL-OMON52268
• Lead Sponsor: Corcym S.r.l

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

- Signed and dated approved Informed Consent
- Subject is willing and able to comply with the follow up schedule of the
protocol
- Eligible for treatment with Corcym aortic, mitral/tricuspid products as
outlined in the applicable IFUs

Exclusion Criteria

-Subject is already participating to another clinical investigation that could
confound the results of this clinical investigation
-Subject has a life expectancy <= 12 months
-Subject has contraindications to the use of Corcym aortic, mitral and/or
tricuspid devices as outlined in the applicable Instructions For Use (IFU)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and performance assessments during the study, up to 10 years after<br /><br>implantation.<br /><br>Endpoints are defined in detail in the sub-study specific protocols.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Statistical strategy, calculation sample handling, data analysis, and reporting<br /><br>methods are described in each sub-study protocol by study-specific design,<br /><br>objective, and planned endpoints of the study.</p><br>