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Clinical Trials in Brazil / NCT06688448
Recruiting Not applicable

Valvular Assessment of New Generation Aortic Replacement Devices

NCT06688448 · tracked via the Priya Life Science Brazil tracker
Sponsor
Instituto Dante Pazzanese de Cardiologia
Phase
Not applicable
Started
2024-12-01
Last updated
2025-01-13

Condition(s) studied

Aortic Regurgitation DiseaseAortic Valve CalcificationBicuspid Aortic Valve Disease

Investigational drug(s) / intervention(s)

Dafodil prosthesisAortic Valve Replacement - Inspires Resilia prosthesis

Dafodil prosthesis: Surgical aortic valve replacement (SAVR) will be performed following standardized protocols to ensure consistency and optimize patient outcomes. Under general anesthesia, a median sternotomy will be conducted to access the aorta. Cardiopulmonary bypass (CPB) will be initiated, and the aorta will be cross-clamped to facilitate the safe removal of the existing prosthesis. After excising the deteriorated valve and removing any calcification, the new bioprosthetic valve will be implanted after randomized.

Aortic Valve Replacement - Inspires Resilia prosthesis: Surgical aortic valve replacement (SAVR) will be performed following standardized protocols to ensure consistency and optimize patient outcomes. Under general anesthesia, a median sternotomy will be conducted to access the aorta. Cardiopulmonary bypass (CPB) will be initiated, and the aorta will be cross-clamped to facilitate the safe removal of the existing prosthesis. After excising the deteriorated valve and removing any calcification, the new bioprosthetic valve will be implanted after randomized.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Rate of bioprosthetic valve deterioration — 12 months
    Participants will be randomized equally to receive either the Dafodil® or INSPIRIS Resilia® valve. The primary outcome is Bioprosthetic valve deterioration, using the standardized definitions and will be assessed using survival analysis.

Trial sites (1)

FacilityCityRegionStatus
Instituto Dante Pazzanese de Cardiologia São Paulo São Paulo Recruiting

More Instituto Dante Pazzanese de Cardiologia trials in Brazil

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Other trials for the same condition

Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Undergoing Valve Surgery. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06688448 on ClinicalTrials.gov ↗ ← All trials in Brazil