Phase 4 Atrial Fibrillation Trial, Recruiting NCT04796714 Sponsor: University Hospital, Bordeaux Condition: Atrial Fibrillation
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Phase 4 Atrial Fibrillation Trial, Recruiting

NCT04796714
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been identified as needing a left atrial appendage closure (a procedure to reduce stroke risk in people with an irregular heartbeat) based on French national medical guidelines.
  • People aged 18 or older.
  • People who have given written consent to take part in the trial.
  • People whose case has been reviewed and approved by a multidisciplinary medical team — including heart specialists, neurologists, and other doctors — who have confirmed that blood-thinning medication is not a suitable option for them.
  • People who are registered under the French social security system.

Who may not be able to join:

  • People under 18 years of age.
  • People for whom a double blood-thinning tablet combination is considered too risky by the doctor who decided blood-thinning medication was not suitable.
  • People who have a blood clot already present in the part of the heart targeted by the procedure.
  • People with a serious illness that means life expectancy is less than one year.
  • People with a severe inherited bleeding disorder.
  • People with a known allergy or sensitivity to aspirin or clopidogrel (common blood-thinning tablets), including those who have experienced asthma triggered by aspirin or similar medications, active stomach ulcers or a history of stomach bleeding related to these medicines, any condition affecting the blood's ability to clot, a condition called mastocytosis (where aspirin can cause severe reactions), severe liver disease, severe kidney disease (confirm with trial site), or uncontrolled severe heart failure.
  • People who cannot have an MRI scan — for example, due to severe claustrophobia, inability to remain still during the scan, or having certain metal implants or medical devices inside the body such as a pacemaker, defibrillator, certain types of heart valve, metal fragments (especially near the eye), brain clips, a cochlear implant, an insulin pump, or a nerve stimulator.
  • People who are under a legal guardianship or curatorship arrangement (a formal legal arrangement where another person manages their affairs).
  • People who are pregnant or who could become pregnant.
  • Women of childbearing age who are not using a highly effective form of contraception as defined by medical guidelines (such as the pill, implant, injection, intrauterine device, or surgical sterilisation).
  • People with a known sensitivity or contraindication to iodine (confirm with trial site).
  • People who are already taking part in another interventional clinical research study of the same category.
  • People who are currently in an exclusion period related to a previous research study.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Zakaria JALAL, MD, University Hospital, Bordeaux

Phone: (0)5 57 65 64 65

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
3 October 2022
Est. completion
3 May 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Change from baseline of ischaemic lesions number at 3 months appearing on brain MRI scans

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov