Left atrial closure device trial for bladder bleeding and atrial fibrillation
Studies whether a heart device can replace blood thinners in adults with bladder bleeding.
Key facts
- Who runs it
- University Hospital, Clermont-Ferrand
- Where
- Clermont-Ferrand, FranceSee the site
- Trial code
- Registry 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
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 24 Feb 2021
- Expected to end
- Sept 2030
- Type of study
- Observational, 2 groups
- Treatments tested
- Percutaneous left atrial closure
- No Percutaneous left atrial closure
- Record updated
- 19 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with blood in the urine caused by radiation damage to the bladder who also have non-valvular atrial fibrillation and take blood thinners.
- Age
- Over 18 years old (minimum 18 years).
- Sex
- All sexes can join.
- Disease stage
- Blood in the urine from radiation cystitis (radiation damage to the bladder), together with non-valvular atrial fibrillation.
- Earlier treatment
- Must be taking blood-thinning (anticoagulant) treatment for atrial fibrillation.
Main reasons for not taking part
- Blood in the urine from any other cause
- Taking anti-platelet medicine for a reason other than atrial fibrillation
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- Patient over 18 years old benefiting a social security sheme
- Patient with hematuric radiation bladder associated with a non valvular anticoagulated atrial fibrillation
Who cannot take part
- Other reason of anti platelet agent using than atrial fibrillation
- All the other hematuria's reasons
Where in France
- CHU Clermont-FerrandClermont-Ferrand, FranceContact: Lise LaclautreTaking people
About the trial
What the trial wants to find out
The etiology of the radiation cystitis is a pelvic irradiation generally performed as part of the treatment of prostate cancer. The incidence is 50,000 new cases per year. Approximately 35% of prostate cancer treatment is radiotherapy. The prevalence of haematuric radiation cystitis is 4-5% (about 800 patients).
Read full original descriptionShow less
One of the complications of radiation cystitis is persistent hematuria. There is currently no curative treatment for this hematuria. There are few treatment options with a random probability of improvement of this symptomatology. These haematurias are rarely resolved spontaneously and most of the time involve emergency room management with +/- invasive procedures, sometimes by hospitalisation, always with a significant psychological impact on the patient.
Furthermore, lifetime anticoagulant treatment considerably increases the likelihood of bladder bleeding. This is the case of patients being followed for Atrial Fibrillation Cardiac Arrhythmia (AFCA), which by definition carries a major cardioembolic risk, and who will be of particular interest in this study.
In recent years, cardiologists have developed an alternative to anticoagulants: left atrial appendage closure or left atrial occlusion (LAO) . This procedure consists of inserting a nitinol prosthesis in the left atrium, the site of more than 90% of thrombi formation in non-valvular atrial fibrillation. This minimally invasive procedure lasts about 15 minutes and is performed during a 48-hour hospitalization. Anticoagulants are stopped the day after the setting up procedure. Several studies have shown non-inferiority of atrial closure and anticoagulants to thromboembolic events in non-valvular atrial fibrillation. In addition, LAO allows the permanent discontinuation of anticoagulants, associated with the cessation of anticoagulant bleeding adverse events.
While studies have been conducted on the impact of this technique on patients monitored in cardiology, no studies evaluate the value of LAO in anticoagulated patients with a hematuric radiation cystitis. This tprocedure is already used in routine care for patients followed in urology, and has shown encouraging results, since 8 out of 10 patients saw a significant reduction in the number of haematurias, but it has never yet been scientifically proven to be effective, hence the aim of this study.
The interest of this study will therefore be :
* To evaluate the potential benefit of left atrial appendage closure on the number of episodes of hematuria. * To evaluate the economic benefit in reducing the number of hospitalizations, surgeries and complications for hematuria as well as the discontinuation of anticoagulants.
As the patient's data must be retrieved regardless of the patient's subsequent management (with or without a cardiac procedure) within the framework of the HEMOCC protocol, it will be proposed to the patient as soon as he or she is consulting for haematuria on radiation cystitis. The patient will be followed for 3 years.
The mainly descriptive analyses will be collected in the form of a register and carried out by a biostatistician from Clermont-Ferrand University Hospital.
The 2 groups in the trial
- with atrial closure
Treatment: Percutaneous left atrial closure
- without atrial occlusion
Treatment: No Percutaneous left atrial closure
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official 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
- Plain-language title
- Left atrial closure device trial for bladder bleeding and atrial fibrillationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 19 March 2026