NCT06688448

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
129mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Dec 2024Dec 2036

First Submitted

Initial submission to the registry

October 3, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2036

Last Updated

January 13, 2025

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

October 3, 2024

Last Update Submit

January 9, 2025

Conditions

Aortic Regurgitation DiseaseAortic Valve CalcificationBicuspid Aortic Valve Disease

Keywords

aortic valve surgeryDafodil®Inspires Resilia®bioprosthetic valvesaortic valve replacement

Outcome Measures

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.

    12 months

Secondary Outcomes (3)

  • Postoperative complications

    30 days

  • Quality of life

    10 years

  • Treatment cost-effectiveness

    10 years

Study Arms (2)

Aortic Valve Replacement - Dafodil Prosthesis

EXPERIMENTAL

Patients indicated for surgical aortic valve replacement will be randomized to receive the Dafodil prosthesis.

Device: Dafodil prosthesis

Aortic Valve Replacement - Inspires Resilia prosthesis

ACTIVE COMPARATOR

Patients indicated for surgical aortic valve replacement will be randomized to receive Inspires Resilia prosthesis.

Device: Aortic Valve Replacement - Inspires Resilia prosthesis

Interventions

Dafodil prosthesisDEVICE

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 - Dafodil Prosthesis
Aortic Valve Replacement - Inspires Resilia prosthesisDEVICE

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, 04012909, Brazil

RECRUITING

Related Links

MeSH Terms

Conditions

Aortic Valve, Calcification ofBicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesAortic Valve DiseaseHeart Valve DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Tacianne Rolemberg Delamain, Master Degree

CONTACT

551150856353patricia.paiva@dantepazzanese.org.br

Kleber Gomes Franchini, PhD

CONTACT

551150856353kleber.franchini@dantepazzanese.org.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, open-label, single-center clinical study with randomization of 200 patients with indication of first-time or re-replacement aortic valve surgery to receive Dafodil® and Inspires Resilia® prostheses in the aortic position, conducted at a tertiary cardiology hospital of Brazilian Unified Health System (SUS)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist assistant

Study Record Dates

First Submitted

October 3, 2024

First Posted

November 14, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2036

Last Updated

January 13, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

IPD (Individual Patient Data) may not be shared due to concerns about patient confidentiality and data protection. Sharing such sensitive information could expose personal details and potentially violate privacy regulations. Additionally, there may be concerns about the misuse of data or its impact on the individuals privacy. Ensuring secure and ethical handling of IPD is crucial to protect patient rights and maintain trust.

Locations

BR(1)