Recruiting NA Aortic Regurgitation Disease

New treatment option for Aortic Regurgitation Disease

Official title Valvular Assessment of New Generation Aortic Replacement Devices

ClinicalTrials.gov ID: NCT06688448

What this study is testing

What it's testing
The VANGUARD study is an open-label, prospective, randomized trial comparing the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil® and INSPIRIS Resilia®, in patients undergoing aortic valve replacement (AVR). This study aims to provide robust data on valve durability, safety, and hemodynamic performance, particularly in younger patients who may require multiple interventions over their lifetimes.
  • Time commitment: about 10 years
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65

You may be able to join if

  • 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.

You likely can't join if

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

The study team makes the final eligibility decision.

Where it's taking place

  • São Paulo, São Paulo, Brazil

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.