Atrial Fibrillation Trial, Recruiting NCT04715425 Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT04715425
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:

  • People aged between 18 and 80 years old.
  • People who have persistent atrial fibrillation (an irregular heart rhythm that is ongoing or has required an electrical shock to reset the heart), confirmed by a heart tracing (ECG) or similar test within the past year.
  • People whose atrial fibrillation has not been controlled by at least one standard heart rhythm medication, or who could not tolerate that medication.
  • People whose left atrium (one of the heart's chambers) is not significantly enlarged, based on a heart scan result (confirm with trial site).
  • People who are legally able to make their own decisions and are willing to sign a consent form.
  • People who are willing and able to attend all required follow-up appointments.
  • People with a life expectancy of at least 2 years.

Who may not be able to join:

  • People who have previously had a catheter-based or keyhole surgical procedure to treat atrial fibrillation.
  • People whose atrial fibrillation is caused by an imbalance of body salts, a thyroid condition, or another reversible or non-heart-related cause.
  • People who have a specific type of abnormal heart rhythm called CTI-dependent atrial flutter.
  • People whose atrial fibrillation is related to a heart valve problem.
  • People who have a pattern of atrial fibrillation that comes and goes (paroxysmal AF) rather than persisting continuously.
  • People whose atrial fibrillation has been continuously present for more than one year (long-standing persistent AF).
  • People with a body mass index (BMI) over 35.
  • People with severe heart failure symptoms (classified as NYHA class IV), or whose heart's pumping function is significantly reduced (ejection fraction below 35%).
  • People with moderate heart failure symptoms (NYHA class III), unless those symptoms are caused or made worse by the atrial fibrillation itself.
  • People who have had a heart attack within the past 2 months.
  • People with an active infection or sepsis, indicated by elevated infection markers or a fever above 38.5°C.
  • People with a known significant narrowing of the carotid artery (a major neck artery) of more than 80%.
  • People who are already scheduled for heart surgery for a reason other than atrial fibrillation.
  • People who are pregnant, or people who could become pregnant and are not using adequate contraception.
  • People who need heart rhythm medication to control a dangerous heart rhythm originating in the lower chambers of the heart.
  • People who have a blood clot or abnormal mass inside the heart.
  • People with other serious health conditions that would make general anaesthesia or heart surgery too risky (as determined by the treating doctor).
  • People who have previously had radiation therapy to the chest area.
  • People whose personal circumstances would make attending follow-up visits impossible.
  • People for whom a catheter cannot be inserted through a blood vessel for the procedure.
  • People who have previously had open chest (thoracotomy) surgery.
  • People for whom a specific step of the catheter procedure (transseptal puncture) cannot be safely performed (confirm with trial site).

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 23 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

Phone: 0205699111

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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Registry
ClinicalTrials.gov
Start date
25 September 2019
Est. completion
1 September 2024

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Freedom of AF, defined as absence of any atrial tachyarrhythmia

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: 23 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