Actively Recruiting
Study of Anticoagulant Interruption Covered by Percutaneous Left Atrial Occlusion in Patients With Chronic Atrial Fibrillation and Radiation Cystitis at Risk of Bleeding
Led by University Hospital, Clermont-Ferrand · Updated on 2026-03-19
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old benefiting from a social security scheme
- Patient with hematuric radiation cystitis associated with non-valvular anticoagulated atrial fibrillation
You will not qualify if you...
- Hematuria caused by reasons other than radiation cystitis
- Use of antiplatelet agents for reasons other than atrial fibrillation treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies depending on scheduling
Participants receive cardiological evaluation to determine the indication for percutaneous left atrial occlusion.
1 visit (in-person)
Duration - Procedure duration plus 2 days of monitoring
Participants who undergo the percutaneous left atrial closure procedure receive the device implantation under general anesthesia, followed by monitoring for 48 hours to ensure safety.
1 procedure visit and approximately 1 to 2 hospital days
Duration - Up to 36 months
Participants are observed for episodes of hematuria and hospitalizations, with data collected regardless of whether the atrial occlusion procedure was performed.
Follow-up visits at baseline, and months 3, 6, 9, 12, 18, 24, 30, and 36
Trial Site Locations
Total: 1 location
1
Chu Clermont Ferrand
Clermont-Ferrand, France, 63003
Actively Recruiting
Research Team
L
Lise Laclautre
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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