DurAVR® THV for Aortic Stenosis

(PARADIGM Trial)

This trial tests a new heart valve, the DurAVR® THV System, for individuals with severe aortic stenosis, a condition where the heart valve narrows excessively. Participants will receive either the DurAVR® valve or a currently approved valve to compare effectiveness. It suits those advised to undergo a transcatheter aortic valve replacement, a procedure that replaces the valve without open-heart surgery, due to severe narrowing. A specific group includes individuals with failing surgical heart valves who face high surgical risks. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from advanced treatment.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

A previous study tested the DurAVR® THV System on 100 patients with aortic stenosis, a condition where the heart valve narrows. The results were promising, with successful valve implantation in all patients. Importantly, no complications arose from the device itself. Only one patient experienced an issue at the insertion site, and one required a permanent pacemaker.

After 30 days, the safety results remained positive. There were no valve-related deaths and no significant leaks around the valve, suggesting the treatment is generally safe for patients.

The DurAVR® THV System is unique because it offers a new approach to treating aortic stenosis by using a different transcatheter heart valve technology. Unlike standard treatments like the SAPIEN or Evolut THV series, which are well-known options, DurAVR® THV aims to improve durability and performance of heart valve replacements. Researchers are excited because this system may provide a longer-lasting solution with potentially fewer complications, which is a big deal for patients needing valve replacements. If successful, it could mean fewer repeat procedures and better long-term outcomes for people with aortic stenosis.

Research has shown that the DurAVR® THV System holds promise for treating aortic stenosis, a condition where the heart's aortic valve narrows. In a study of 100 patients with severe aortic stenosis, 91% experienced successful results with the device after 30 days, with no deaths and a low stroke rate of 2%. Importantly, there were no valve-related deaths or significant leaks around it. For patients with small aortic openings, the valve provided excellent blood flow. Additionally, some patients demonstrated positive results after one year, supporting its potential effectiveness in managing severe aortic stenosis. In this trial, participants will receive either the DurAVR® THV System or a control treatment with the SAPIEN THV series or the Evolut THV series to compare outcomes.¹³⁵⁶⁷