European muLtIcentric Solo International Registry

Phase 4

Completed

• Conditions: 10007593; heart valve disease; 10046973

• Registration Number: NL-OMON30401
• Lead Sponsor: Sorin Biomedica Cardio s.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

* Patients are male or female 18 years old or older;
* Patients are willing to sign the informed consent;
* Patients which preoperative evaluation indicated the need for native aortic valve replacement;
* A bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve according to the current medical practice for valve selection at the centre.

Exclusion Criteria

* Patients with severe evolving systemic diseases which could compromise the regular control visits or determine life expectancy minor than the duration of the study;
* Patients with ejection fraction < 30%;
* Patients with collagenophatic autoimmune disease;
* Patients affected by disorder of calcium metabolism;
* Patients with congenital malformation (bicuspid aortic valve);
* Patients with evident coronary ostia and Valsalva sinuses asymmetry;
* Patients currently participating in the study of an investigational drug or device;
* Patients who are drug abusers, alcohol abuser or unable to give informed consent;
* Patients who are HIV positive;
* Patients with active endocarditis;
* Patients required double valve replacement;
* Patients are known to be noncompliant or are unlikely to complete the study;
* Any other case in which SOLO valve is not indicated.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>morbidity and mortality at 3 and 12 month follow-up after aortic valve<br /><br>replacement</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- NYHA class at 3 and 12 month follow-up after aortic valve replacement;<br /><br>- echocardiographic parameters (EOA, MPG, PPG) at preoperative time, 3 and 12<br /><br>months after aortic valve replacement<br /><br>- Evaluation of suturing time of the Freedom SOLO.</p><br>