Atrial Fibrillation Trial, Recruiting NCT05264831 Sponsor: Elsan Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT05264831
Recruiting Not Applicable

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:

  • You have persistent atrial fibrillation (an irregular heartbeat that has continued without stopping for at least 7 days), confirmed by your cardiologist
  • Your atrial fibrillation causes symptoms and has not been controlled by at least one heart rhythm medication, including amiodarone
  • You have either already had an electric shock treatment (cardioversion) to reset your heart rhythm, with a procedure to treat the AF planned within 4–6 weeks after that, OR you are being considered for cardioversion before joining the trial
  • You are between 18 and 80 years old at the time of your cardioversion
  • You are expected to live for more than 5 years
  • You are covered by a health insurance system
  • You have been fully informed about the study and have signed a consent form
  • At the time of the heart procedure (ablation), your heart is still in an irregular rhythm, confirmed by a heart tracing (ECG)

Who may not be able to join:

  • You currently have an overactive thyroid gland
  • You are pregnant or breastfeeding
  • Your Body Mass Index (BMI) is above 35 (confirm with trial site)
  • You have severe chronic lung disease (COPD)
  • You have a condition where the heart muscle is abnormally thick
  • You have an artificial or donor tissue valve in your mitral heart valve
  • You cannot safely take blood-thinning medications
  • You have had a mini-stroke or stroke within the last 6 months
  • You have a psychiatric illness that might affect your ability to attend follow-up appointments
  • Your heart's pumping strength (ejection fraction) is below 40%
  • You have heart disease causing chest pain or reduced blood flow to the heart that is not well controlled
  • You are under a legal protection order (confirm with trial site)
  • You have previously had surgery on the left chamber of your heart
  • You have an active inflammatory condition such as cancer, rheumatoid arthritis, Crohn's disease, or certain other inflammatory diseases (confirm with trial site)
  • You have had a blood clot in your lungs or legs within the last 6 months
  • You have previously had a procedure (ablation) to treat atrial fibrillation
  • You have active cancer
  • If your heart rhythm has returned to normal 4–6 weeks after cardioversion, you cannot take part in the main trial (but may be entered into a separate study registry)
  • If your heart rhythm does not return to normal at all after three cardioversion attempts, you will not be able to continue in the 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 6 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Augustin Bortone, MD, Elsan

Phone: 04 66 26 63 75

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
Not Applicable
Sponsor
Elsan
Registry
ClinicalTrials.gov
Start date
20 February 2023
Est. completion
1 April 2025

Where this trial is recruiting

🇫🇷 France

Primary endpoints

1-year sinus rhythm maintenance rate

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: 6 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