Comparative Efficacy and Durability of Next-Generation Biological Aortic Prostheses.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of bioprosthetic valve deterioration
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Indicated for mechanical prosthetic valve replacement.
- •Require surgical intervention in another heart valve or transcatheter valve therapy.
研究组 & 干预措施
Aortic Valve Replacement - Dafodil Prosthesis
Patients indicated for surgical aortic valve replacement will be randomized to receive the Dafodil prosthesis.
干预措施: Dafodil prosthesis (Device)
Aortic Valve Replacement - Inspires Resilia prosthesis
Patients indicated for surgical aortic valve replacement will be randomized to receive Inspires Resilia prosthesis.
干预措施: Aortic Valve Replacement - Inspires Resilia prosthesis (Device)
结局指标
主要结局
Rate of bioprosthetic valve deterioration
时间窗: 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.
次要结局
- Quality of life(10 years)
- Treatment cost-effectiveness(10 years)
- Postoperative complications(30 days)
研究者
Tacianne Rolemberg Braga Delamain
Cardiologist assistant
Instituto Dante Pazzanese de Cardiologia