Valvular Assessment of New Generation Aortic Replacement Devices (VANGUARD)

January 9, 2025 updated by: Tacianne Rolemberg Braga Delamain, Instituto Dante Pazzanese de Cardiologia

Comparative Efficacy and Durability of Next-Generation Biological Aortic Prostheses.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This single-center, prospective open-label randomized clinical trial will enroll 200 patients indicated for aortic native valve or prosthetic valve replacement. Participants will be randomly assigned in a 1:1 ratio to receive the Dafodil® or INSPIRIS Resilia® prosthesis. The trial will be conducted at a leading tertiary cardiology hospital within the Brazilian Unified Health System (SUS). The study is sponsored by Instituto Dante Pazzanese de Cardiologia and Fundação Adib Jatene, with device supply supported by Meril Life Sciences (Vapi, Gujarat, India) and Edwards Lifesciences (Irvine, CA, USA).

Screening and Recruitment Process Participants will be identified through in-hospital referrals and outpatient clinics. The screening process will involve a comprehensive review of medical histories, imaging studies (e.g., echocardiograms), and relevant laboratory tests. To ensure a representative sample and minimize selection bias, the study will actively recruit patients with diverse comorbidities and histories of prior surgical procedures.

Informed Consent Process The informed consent process will adhere to stringent ethical standards, ensuring that participants fully understand the purpose, procedures, potential risks, and benefits of the study. The trained study personnel will provide detailed explanations and answer any questions. Patients will be informed of their right to withdraw from the study at any time without impacting their standard of care. Consent will be documented according to institutional guidelines.

Randomization and Blinding Participants will be randomized in a 1:1 ratio using the RedCap system , a secure web-based platform specifically designed for clinical trials. The randomization sequence will be generated using permuted blocks of varying sizes to maintain allocation concealment and ensure a balanced distribution across treatment groups.

Although the study is open-label due to the inherent nature of the surgical procedures, several strategies will be implemented to minimize bias:

  • Outcome Adjudication and Imaging Assessment: Assessors responsible for evaluating postoperative echocardiographic imaging results and adjudicators of clinical outcomes will remain blinded to treatment allocation, thereby reducing the risk of observer bias.
  • Centralized Data Monitoring: An independent team, blinded to treatment assignments, will conduct centralized data monitoring during audits and interim analyses, further safeguarding the study's integrity.
  • Objective Outcome Measures: The study will prioritize objective measures, such as hemodynamic parameters and imaging findings, to minimize the potential influence of subjective bias.

Interventions Surgical Procedure: 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-either Dafodil® or INSPIRIS Resilia®-will be implanted. Transesophageal echocardiography (TEE) will be utilized to assess valve function prior to weaning the patient off CPB. The procedure will conclude with the closure of the sternum and the patients transfer to the intensive care unit (ICU) for postoperative monitoring.

Postoperative Care: All patients will receive standardized postoperative care, encompassing anticoagulation management, pain control, and vigilant monitoring for potential complications. Follow-up assessments will include routine imaging and clinical evaluations to monitor recovery and verify the proper function of the implanted prosthesis. These evaluations will be scheduled at predetermined intervals to ensure timely detection and management of any issues that may arise.

Follow-up Schedule Participants will undergo follow-up evaluations at 30 days, 3 months, and annually for up to 10 years post-surgery. Each visit will encompass comprehensive data collection, including medical history updates, current medications, laboratory test results, electrocardiograms (ECGs), and echocardiograms. This structured follow-up schedule is designed to monitor patient recovery, assess the functionality of the implanted prosthesis, and promptly identify any emerging complications.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aortic Valve Replacement - Dafodil Prosthesis
Patients indicated for surgical aortic valve replacement will be randomized to receive the Dafodil prosthesis.
Device: 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.
Active Comparator: Aortic Valve Replacement - Inspires Resilia prosthesis
Patients indicated for surgical aortic valve replacement will be randomized to receive Inspires Resilia prosthesis.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of bioprosthetic valve deterioration
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 30 days
Evaluate postoperative complications including hospitalization time, arrhythmias, bleeding, and surgical complications.
30 days
Quality of life
Time Frame: 10 years
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.
10 years
Treatment cost-effectiveness
Time Frame: 10 years
Treatment cost-effectiveness will be assessed from the healthcare system perspective, focusing on time to valve deterioration and the need for subsequent procedures.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Dante Pazzanese de Cardiologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2036

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VANGUARD
  • Own resources (Other Identifier: Fundação Adib Jatene)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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