Comparing new bioprosthetic aortic valves for heart surgery

Comparative Efficacy and Durability of Next-Generation Biological Aortic Prostheses.

This study is testing two new types of heart valves to see which one works better for younger patients needing aortic valve replacement surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Instituto Dante Pazzanese de Cardiologia (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06688448 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement. It is a prospective, randomized trial enrolling 200 patients who will be assigned to receive one of the two prostheses. The study aims to gather data on valve durability, safety, and hemodynamic performance, particularly focusing on younger patients who may need multiple interventions throughout their lives. Conducted at a leading cardiology hospital in Brazil, the trial emphasizes a thorough screening and informed consent process to ensure participant understanding and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who need surgical replacement of their aortic valve.

Not a fit: Patients indicated for mechanical prosthetic valve replacement or those requiring intervention on other heart valves may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes and longevity of bioprosthetic aortic valves for patients requiring valve replacement.

How similar studies have performed: Other studies have shown promising results with advanced bioprosthetic valves, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Age: 18 to 65 years.
* Eligible for surgical replacement of native valve or re-replacement of a prosthetic valve with a bioprosthetic valve in the aortic position.

Exclusion Criteria:

* Indicated for mechanical prosthetic valve replacement.
* Require surgical intervention in another heart valve or transcatheter valve therapy.

Where this trial is running

São Paulo, São Paulo

• Instituto Dante Pazzanese de Cardiologia — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Tacianne Rolemberg Delamain, Master Degree

Conditions Aortic Regurgitation Disease; Aortic Valve Calcification; Bicuspid Aortic Valve Disease; aortic valve surgery; Dafodil®; Inspires Resilia®; bioprosthetic valves; aortic valve replacement