Study Comparing Two New Bioprosthetic Aortic Valves, Dafodil and INSPIRIS Resilia, in Patients Undergoing Aortic Valve Replacement

What this Trial Is About

Researchers are evaluating the long-term outcomes of two advanced bioprosthetic aortic valves, Dafodil4 and INSPIRIS Resilia4, in patients undergoing aortic valve replacement. This study aims to gather strong data on valve durability, safety, and how well the valves work, especially for younger patients who may need multiple valve interventions over their lifetime. The trial is an open-label, prospective, randomized study conducted at a cardiology hospital within the Brazilian Unified Health System. Participants will be randomly assigned to receive either the Dafodil4 or INSPIRIS Resilia4 prosthesis during surgical aortic valve replacement. The surgery involves general anesthesia, a median sternotomy, use of cardiopulmonary bypass, and removal of the existing valve before implanting the new bioprosthetic valve. After surgery, patients receive standardized care including anticoagulation, pain management, and monitoring for complications. Follow-up visits are scheduled at 30 days, 3 months, and then annually for up to 10 years. During the study, participants will have regular assessments including medical history updates, medication reviews, lab tests, electrocardiograms ECGs, and echocardiograms to monitor valve function and recovery. Researchers will measure the rate of valve deterioration at 12 months as a primary outcome. Secondary outcomes include postoperative complications, quality of life, and cost-effectiveness over 10 years. Data monitoring is done by an independent, blinded team to ensure objective evaluation and study integrity.

Valvular Assessment of New Generation Aortic Replacement Devices