Valve Replacement for Bicuspid Aortic Valve Disease

(BELIEVERS Trial)

This trial seeks to determine the best treatment for individuals with severe aortic stenosis (a narrowing of the heart valve) who have a bicuspid aortic valve (a valve with two flaps instead of three). Participants will be randomly assigned to receive either a Transcatheter Aortic Valve Replacement (TAVR), a less invasive procedure, or a Surgical Aortic Valve Replacement (SAVR), which involves open-heart surgery. Eligible participants must have a diagnosis of severe aortic stenosis and the option to choose a bioprosthetic valve (a valve made from animal tissue). This study aims to guide patients and doctors in selecting the most suitable treatment. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance treatment options for future patients.

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.

Research has shown that both Transcatheter Aortic Valve Replacement (TAVR) and Surgical Aortic Valve Replacement (SAVR) are generally safe for treating narrowed bicuspid aortic valves.

For TAVR, studies have found it safe and effective. In one study, 99.3% of patients survived the procedure, and 96% of the valves were placed correctly. Most patients experienced little or no leakage around the valve afterward. Another study showed a similar success rate for patients with both bicuspid and tricuspid aortic valves, with 97% achieving a successful outcome.

SAVR has demonstrated safety and effectiveness over the long term. One study found that 96.3% of patients survived two years post-procedure. SAVR also provided more lasting results and fewer strokes over time compared to TAVR.

Unlike the standard of care for bicuspid aortic valve disease, which involves open-heart surgery, Transcatheter Aortic Valve Replacement (TAVR) uses a less invasive, percutaneous approach. This means that instead of opening the chest, the valve is replaced through a catheter inserted into a blood vessel, often in the groin. This method can lead to quicker recovery times and is often suitable for patients who might not be ideal candidates for traditional surgery. Meanwhile, Surgical Aortic Valve Replacement (SAVR) remains the tried-and-true open chest surgery option, serving as a benchmark for evaluating new procedures like TAVR. Researchers are excited about TAVR because it offers a promising alternative with potentially fewer complications and faster recovery.

This trial will compare Transcatheter Aortic Valve Replacement (TAVR) and Surgical Aortic Valve Replacement (SAVR) for treating bicuspid aortic valve disease. Research has shown that both TAVR and SAVR are effective treatments. Studies have found that TAVR is safe and offers similar one-year survival rates compared to patients with normal three-part valves, though it may have slightly lower device success. TAVR typically results in fewer short-term issues like bleeding compared to SAVR. However, SAVR often provides better long-term survival and a lower risk of stroke. Each treatment has its advantages, and the choice often depends on the specific needs and risks of each patient. Participants in this trial will receive either the TAVR or SAVR treatment to further evaluate these outcomes.¹²⁶⁷⁸