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 (HEMOCC)

March 18, 2026 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
with atrial closure
Device: Percutaneous left atrial closure
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.
without atrial occlusion
Other: No Percutaneous left atrial closure
No Percutaneous left atrial closure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants
Time Frame: Baseline (Month 0)
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
Time Frame: Month 3
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
Time Frame: Month 6
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
Time Frame: Month 9
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
Time Frame: Month 12
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
Time Frame: Month 18
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
Time Frame: Month 24
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
Time Frame: Month 30
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
Time Frame: Month 36
number of episodes of hematuria following atrial occlusion and discontinuation of anticoagulants collected with a data collection form
Month 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of days hospitalizations for hematuria
Time Frame: Baseline (Month 0)
assessed by phone contact
Baseline (Month 0)
Number of days hospitalizations for hematuria
Time Frame: Month 3
assessed by phone contact
Month 3
Number of days hospitalizations for hematuria
Time Frame: Month 6
assessed by phone contact
Month 6
Number of days hospitalizations for hematuria
Time Frame: Month 9
assessed by phone contact
Month 9
Number of days hospitalizations for hematuria
Time Frame: Month 12
assessed by phone contact
Month 12
Number of days hospitalizations for hematuria
Time Frame: Month 18
assessed by phone contact
Month 18
Number of days hospitalizations for hematuria
Time Frame: Month 24
assessed by phone contact
Month 24
Number of days hospitalizations for hematuria
Time Frame: Month 30
assessed by phone contact
Month 30
Number of days hospitalizations for hematuria
Time Frame: Month 36
assessed by phone contact
Month 36
duration of hematuria episodes
Time Frame: Baseline (Month 0)
assessed by phone contact
Baseline (Month 0)
duration of hematuria episodes
Time Frame: Month 3
assessed by phone contact
Month 3
duration of hematuria episodes
Time Frame: Month 6
assessed by phone contact
Month 6
duration of hematuria episodes
Time Frame: Month 9
assessed by phone contact
Month 9
duration of hematuria episodes
Time Frame: Month 12
assessed by phone contact
Month 12
duration of hematuria episodes
Time Frame: Month 18
assessed by phone contact
Month 18
duration of hematuria episodes
Time Frame: Month 24
assessed by phone contact
Month 24
duration of hematuria episodes
Time Frame: Month 30
assessed by phone contact
Month 30
duration of hematuria episodes
Time Frame: Month 36
assessed by phone contact
Month 36
number of hematuria surveys
Time Frame: Baseline (Month 0)
assessed by phone contact
Baseline (Month 0)
number of hematuria surveys
Time Frame: Month 3
assessed by phone contact
Month 3
number of hematuria surveys
Time Frame: Month 6
assessed by phone contact
Month 6
number of hematuria surveys
Time Frame: Month 9
assessed by phone contact
Month 9
number of hematuria surveys
Time Frame: Month 12
assessed by phone contact
Month 12
number of hematuria surveys
Time Frame: Month 18
assessed by phone contact
Month 18
number of hematuria surveys
Time Frame: Month 24
assessed by phone contact
Month 24
number of hematuria surveys
Time Frame: Month 30
assessed by phone contact
Month 30
number of hematuria surveys
Time Frame: Month 36
assessed by phone contact
Month 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurent GUY, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNI 2020 GUY
  • 2020-A02246-33 (Other Identifier: 2020-A02246-33)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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