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

NCT04701749 | Recruiting

• 2 other identifiers: RNI 2020 GUY2020-A02246-33
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-valvular Atrial Fibrillation; Radiation Cystitis

Keywords

radiation cystitis; Hematuria; Left atrial appendage closure or left atrial occlusion (LAO)

Outcome Measures

Primary Outcomes (9)

• number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants

  number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form

  Baseline (Month 0)

• number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants

  number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form

  Month 3

• number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants

  number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form

  Month 6

• number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants

  number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form

  Month 9

• number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants

  number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form

  Month 12

• number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants

  number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form

  Month 18

• number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants

  number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form

  Month 24

• number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants

  number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form

  Month 30

• number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants

  number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form

  Month 36

Secondary Outcomes (27)

• Number of days hospitalizations for hematuria

  Baseline (Month 0)

• Number of days hospitalizations for hematuria

  Month 3

• Number of days hospitalizations for hematuria

  Month 6

• Number of days hospitalizations for hematuria

  Month 9

• Number of days hospitalizations for hematuria

  Month 12

Study Arms (2)

with atrial closure

Device: Percutaneous left atrial closure

without atrial occlusion

Other: No Percutaneous left atrial closure

Interventions

Percutaneous left atrial closure DEVICE

Percutaneous left atrial closure was performed under general anesthesia with angiographic control and transesophageal echocardiography. The procedure takes between 15 and 20 minutes. This begins with a right femoral venipuncture, progression of the guide in the right atrium allowing atrial trans-septal puncture to catheterize the left atrium. A nitinol prosthesis is implanted (Boston Watchman) at the ostium of the left auricle between the left superior pulmonary vein and the circumflex artery. After a tensile test verifying the stability of the prosthesis, the absence of peri-prosthetic leakage is verified by ETO and angiographic control. The patient is monitored 48 hours before discharge to eliminate the appearance of pericardial effusion and prosthetic embolization. Aspirin 75 mg monotherapy is started the same day with stopping anticoagulation.

with atrial closure

No Percutaneous left atrial closure OTHER

No Percutaneous left atrial closure

without atrial occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with at least one hematuria while on anticoagulant therapy for non-valvular atrial fibrillation

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Hematuria

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent GUY

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: February 24, 2021
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

FR (1)