Clinical trial NCT04701749: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiation Cystitis
Non-valvular Atrial Fibrillation
Keywords: radiation cystitis
Hematuria
Left atrial appendage closure or left atrial occlusion (LAO)
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with at least one hematuria while on anticoagulant therapy for non-valvular atrial fibrillation

Brief summary: 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).

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.

Detailed description: Prospective single-centre observational study involving the creation of a data registry of patients with anticoagulation-treated non-valvular atrial fibrillation with hematuria on radiation cystitis.

Patients who present a hematuria on radial bladder associated with anticoagulated atrial fibrillation will be recruited into the protocol by an urologist from Gabriel MONTPIED UHC once they have presented at least one episode of hematuria on radial bladder under anticoagulant treatment in the context of a non-valvular ACFA, and once they have given their agreement to participate in the HEMOCC research protocol.

A research associate will meet the patient to finalize the administrative and practical aspects of inclusion and the collection of retrospective data. Regardless of whether or not left atrial occlusion is performed, the patient's data included in the protocol will be collected.

The urologist will then refer the patient to Pr ESCHALIER's cardiology department for cardiological advice regarding an indication of percutaneous occlusion of the left atrium (running walk).

If LAO is indicated and the patient agrees to the procedure, then the procedure will be scheduled.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old benefiting a social security sheme.
* Patient with hematuric radiation bladder associated with a non valvular anticoagulated atrial fibrillation.

Exclusion Criteria:

* All the other hematuria's reasons
* Other reason of anti platelet agent using than atrial fibrillation

Primary outcomes:
measure: number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
timeFrame: Baseline (Month 0)
measure: number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
timeFrame: Month 3
measure: number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
timeFrame: Month 6
measure: number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
timeFrame: Month 9
measure: number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
timeFrame: Month 12
measure: number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
timeFrame: Month 18
measure: number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
timeFrame: Month 24
measure: number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
timeFrame: Month 30
measure: number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
timeFrame: Month 36
Secondary outcomes:
measure: Number of days hospitalizations for hematuria
timeFrame: Baseline (Month 0)
measure: Number of days hospitalizations for hematuria
timeFrame: Month 3
measure: Number of days hospitalizations for hematuria
timeFrame: Month 6
measure: Number of days hospitalizations for hematuria
timeFrame: Month 9
measure: Number of days hospitalizations for hematuria
timeFrame: Month 12
measure: Number of days hospitalizations for hematuria
timeFrame: Month 18
measure: Number of days hospitalizations for hematuria
timeFrame: Month 24
measure: Number of days hospitalizations for hematuria
timeFrame: Month 30
measure: Number of days hospitalizations for hematuria
timeFrame: Month 36
measure: duration of hematuria episodes
timeFrame: Baseline (Month 0)
measure: duration of hematuria episodes
timeFrame: Month 3
measure: duration of hematuria episodes
timeFrame: Month 6
measure: duration of hematuria episodes
timeFrame: Month 9
measure: duration of hematuria episodes
timeFrame: Month 12
measure: duration of hematuria episodes
timeFrame: Month 18
measure: duration of hematuria episodes
timeFrame: Month 24
measure: duration of hematuria episodes
timeFrame: Month 30
measure: duration of hematuria episodes
timeFrame: Month 36
measure: number of hematuria surveys
timeFrame: Baseline (Month 0)
measure: number of hematuria surveys
timeFrame: Month 3
measure: number of hematuria surveys
timeFrame: Month 6
measure: number of hematuria surveys
timeFrame: Month 9
measure: number of hematuria surveys
timeFrame: Month 12
measure: number of hematuria surveys
timeFrame: Month 18
measure: number of hematuria surveys
timeFrame: Month 24
measure: number of hematuria surveys
timeFrame: Month 30
measure: number of hematuria surveys
timeFrame: Month 36
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Laurent GUY
role: PRINCIPAL_INVESTIGATOR
References: