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Valvular Assessment of New Generation Aortic Replacement Devices

ConditionsAortic Regurgitation DiseaseAortic Valve CalcificationBicuspid Aortic Valve Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstituto Dante Pazzanese de Cardiologia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Indicated for mechanical prosthetic valve replacement.

Require surgical intervention in another heart valve or transcatheter valve therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dafodil prosthesis

    Device

    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

    Device

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Aortic Valve Replacement - Dafodil ProsthesisExperimental treatment 1 intervention
Group B: Aortic Valve Replacement - Inspires Resilia prosthesisActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of bioprosthetic valve deterioration

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.

Time frame
12 months

Secondary outcomes

1

Postoperative complications

Evaluate postoperative complications including hospitalization time, arrhythmias, bleeding, and surgical complications.

Time frame
30 days
2

Quality of life

Quality of life will be assessed by The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). It is a simple, feasible, and sensitive questionnaire developed for assessing the health status composed of 4 domains: (1) physical limitation (items 1a, 1b, 1c), (2) symptom, frequency (items 2, 3, 4, 5), quality-of-life (items 6, 7), and social limitation (items 8a, 8b, 8c), \[5\] which are averaged to generate the Overall Summary score. Scores range from 0 to 100, with higher scores indicating fewer symptoms or limitations and better quality of life. To support its interpretation, cross-sectional scores of 0-24 indicate very poor to poor health status, 25-49 poor to fair, 50-74 fair to good, and 75-100 good to excellent health status. Changes of 5, 10, and ≥20 points indicate small but clinically important, moderate to large, and large to very large changes in patients' health status.

Time frame
10 years
3

Treatment cost-effectiveness

Treatment cost-effectiveness will be assessed from the healthcare system perspective, focusing on time to valve deterioration and the need for subsequent procedures.

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto Dante Pazzanese de Cardiologia

Lead sponsor

Source ClinicalTrials.gov
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