Comparing new bioprosthetic aortic valves for heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Instituto Dante Pazzanese de Cardiologia
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Tacianne Rolemberg Delamain, Master Degree
• Email: patricia.paiva@dantepazzanese.org.br
• Phone: 551150856353

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Losartan after aortic valve replacement to help the heart recover

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• ARTEMIS: JenaValve Trilogy data collection for severe aortic regurgitation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.