Comparing the Durability and Performance of Dafodil and INSPIRIS Resilia Bioprosthetic Aortic Valves in Surgical Replacement A Study on Next-Generation Aortic Valve Devices

What this Trial Is About

The VANGUARD study is a prospective, open-label, randomized trial comparing two advanced bioprosthetic aortic valves, Dafodil4 and INSPIRIS Resilia4, in patients undergoing aortic valve replacement. The research aims to provide strong data on the durability, safety, and heart function of these valves, especially focusing on younger patients aged 18 to 65 who may need multiple valve interventions over their lifetime. The trial is conducted at a leading cardiology center in Brazil and involves 200 participants. Participants will be randomly assigned to receive either the Dafodil4 or INSPIRIS Resilia4 bioprosthetic valve during surgical aortic valve replacement. The procedure involves general anesthesia, a median sternotomy, use of cardiopulmonary bypass, removal of the deteriorated valve, and implantation of the randomized bioprosthetic valve. Postoperative care includes standardized management and monitoring in the intensive care unit. Follow-up visits are scheduled at 30 days, 3 months, and annually for up to 10 years to monitor valve function and patient recovery. Throughout the study, participants will have medical history reviews, medication updates, laboratory tests, electrocardiograms, and echocardiograms performed at each follow-up visit. Imaging assessments and clinical outcomes will be evaluated by blinded assessors to reduce bias. The primary outcome measured is the rate of bioprosthetic valve deterioration at 12 months. Long-term monitoring is planned to capture valve performance and safety over time.

Valvular Assessment of New Generation Aortic Replacement Devices