Study to Evaluate Left Atrial Closure for Patients with Non-Valvular Atrial Fibrillation and Radiation Cystitis Causing Bleeding

What this Trial Is About

Researchers are investigating the effects of stopping anticoagulant medications with the support of a minimally invasive procedure called percutaneous left atrial occlusion LAO in patients who have chronic atrial fibrillation and radiation cystitis causing bleeding in the bladder. Radiation cystitis is a side effect that can cause persistent blood in the urine, which is difficult to treat and often requires emergency care. This study aims to evaluate if LAO can reduce bleeding episodes and hospitalizations related to this condition. The study observes patients who have non-valvular atrial fibrillation treated with anticoagulants and develop hematuria due to radiation cystitis. Some patients may receive the LAO device, a nitinol prosthesis implanted via a catheter through the femoral vein under anesthesia, which blocks the left atrial appendage to reduce clot risk and allow anticoagulant discontinuation. Others may continue their usual anticoagulant treatment without the device. The procedure lasts about 15-20 minutes, followed by 48 hours of monitoring. Participants will be followed for up to 3 years with data collected on the number and duration of hematuria episodes, hospitalizations, and surveys about bleeding. Data is gathered regardless of whether patients undergo the LAO procedure. Researchers will analyze these outcomes over multiple time points to understand the impact of LAO on bleeding frequency and health resource use, helping to inform care for patients with this challenging condition.

Study of the Effects of Anticoagulant Interruption Covered by Percutaneous Left Atrial Occlusion in Patients With Chronic Atrial Fibrillation and Radiation Cystitis at Risk of Bleeding