Atrial Fibrillation Trial, Recruiting NCT06199180 Sponsor: University Medical Center Groningen Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT06199180
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 who have had one previous pulmonary vein isolation (a specific heart procedure for atrial fibrillation) using one of three methods: cryoballoon, radiofrequency ablation, or pulsed field ablation
  • People whose first pulmonary vein isolation procedure took place less than 5 years before joining the trial
  • People who have had a documented return of atrial fibrillation (an irregular heart rhythm) lasting more than 30 seconds
  • People whose atrial fibrillation causes noticeable symptoms
  • People who have paroxysmal atrial fibrillation (episodes that start and stop on their own)
  • People aged between 18 and 79 years old
  • People who are willing and able to give informed consent to participate
  • People who are able and willing to attend all required check-ups, visits, and tests throughout the study

Who may not be able to join:

  • People who have persistent atrial fibrillation, meaning episodes that last longer than 7 days
  • People who have been diagnosed with certain other heart rhythm problems, specifically atrial tachycardia or atrial flutter (confirm with trial site, as one common type of flutter may not be excluded)
  • People who had additional heart tissue ablated outside the pulmonary veins during their first procedure
  • People whose atrial fibrillation is caused by a treatable or non-heart-related condition, such as a thyroid problem, electrolyte imbalance, or alcohol use
  • People who cannot take or are unwilling to take blood-thinning medication
  • People whose heart pumping function is significantly reduced, specifically a pumping efficiency below 30% as measured by a heart ultrasound taken within the past 3 months
  • People with an enlarged left chamber of the heart beyond a certain measurement
  • People who have other significant heart rhythm problems besides atrial fibrillation
  • People who have previously had surgery specifically to treat atrial fibrillation
  • People with significantly limited heart function affecting daily activities (classified as NYHA Class III or IV)
  • People who have a blood clot, tumour, or other abnormality inside the heart that would make the procedure unsafe
  • People with a body mass index (a measure of body weight relative to height) above 35
  • People with significant low blood pressure, an abnormally slow heart rate, or a heart that cannot increase its rate appropriately
  • People with severely reduced kidney function or a history of kidney dialysis or kidney transplant
  • People with serious heart valve problems
  • People who have a device previously placed to close a hole in the heart (patent foramen ovale or atrial septal defect closure device)
  • People with a history of abnormal bleeding or clotting problems
  • People with a history of rheumatic fever
  • People with severe lung disease or high blood pressure in the lungs, but only where this affects blood oxygen levels or causes significant breathlessness (confirm with trial site)
  • People with a significant active infection or sepsis
  • People whose life expectancy is less than one year
  • People with an allergy to contrast dye used in medical imaging that cannot be controlled with pre-medication
  • People who have experienced any of the following in the 3 months before joining the trial: a heart attack, unstable chest pain, a procedure to open blocked heart arteries, a hospital admission for heart failure, a stroke or mini-stroke, significant bleeding, inflammation around the heart or fluid around the heart, or a blood clot in the left chamber of the heart
  • People who have had open-heart bypass surgery or a related heart procedure within the 6 months before joining
  • People who have had an organ or blood cell transplant, or who are currently being assessed for one
  • People who are pregnant or breastfeeding

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 27 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: Yuri Blaauw, Dr., University Medical Center Groningen

Phone: +31503616161

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
Registry
ClinicalTrials.gov
Start date
20 September 2024
Est. completion
1 September 2028

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

To compare the efficacy of repeat pulmonary vein isolation (PVI) with PFA or point-by-point RF ablation.

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: 27 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