Comparing pulsed field ablation and radiofrequency ablation for repeat treatment of atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to compare the effectiveness and safety of pulsed field ablation (PFA) versus conventional radiofrequency ablation (RFA) in patients with recurrent atrial fibrillation (AF) who have previously undergone pulmonary vein isolation (PVI). A total of 154 patients will be randomly assigned to receive either PFA or RFA, with an implantable cardiac monitor used to track AF recurrence. The study will take place across six clinical centers in the Netherlands, and patients will be monitored for pulmonary vein reconnection during the ablation procedure. The goal is to determine which method provides better outcomes for patients requiring repeat PVI.

Why it matters

Who can join: the full rules

Subjects who meet all of the following inclusion criteria at screening will be eligible for enrolment:

* Patient had 1 previous PVI with either cryoballoon, RF ablation or PFA
* Index PVI occurred within \<5 years prior to enrolment
* Documented AF recurrence \>30 seconds
* Symptomatic AF
* Paroxysmal AF
* Age \>18 and \<80 years
* Willing and capable to provide informed consent
* Able and willing to participate in all examinations and follow-up visits and tests associated with this clinical study

Subjects who meet ANY of the following exclusion criteria will be excluded from the study:

* Persistent AF (by diagnosis of duration \>7 days)
* Concomitant/ prior diagnosis for atrial tachycardia (AT) and/or atrial flutter (AFl). Note typical cavotricuspid isthmus dependent flutter is not an exclusion criterium.
* Underwent additional ablations outside the pulmonary veins during index AF ablation
* AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
* Contraindication to, or unwillingness to use, systematic anticoagulation
* Left ventricular ejection fraction (LVEF) \<30% as documented by transthoracic echo (TTE) (within \<3 months prior)
* Left atrial volume index \>60 ml/m2
* Clinically significant arrhythmias other than AF
* Previous surgery for AF
* New York Heart Association (NYHA) Functional Class III or IV
* Presence of intramural thrombus, tumour or other abnormality that precludes safe catheter introduction or manipulation
* BMI \>35 kg/m2
* Significant or symptomatic hypotension, bradycardia, or chronotropic incompetence
* Chronic renal insufficiency of \<15 mL/min/1.73 m2 or any history of renal dialysis, or history of renal transplant
* Hemodynamically significant valvular disease
* Presence of patent foramen ovale (PFO) or atrial septal defect (ASD) closure device
* History of abnormal bleeding and/or clotting disorder
* History of rheumatic fever
* Severe lung disease, pulmonary hypertension, or any lung disease. Only if involving abnormal blood gases or significant dyspnoea
* Clinically significant systemic infection or sepsis
* Life expectancy \<1 year
* Sensitivity to contrast media not controlled by pre-medication
* Any of the following within the 3 months prior to enrolment:

  * Myocardial infarction
  * Unstable angina
  * Percutaneous coronary intervention
  * Heart failure hospitalization
  * Stroke or TIA
  * Significant bleeding
  * Pericarditis/effusions
  * Left atrial thrombus
* Coronary artery bypass grafting/atriotomy within 6 months prior
* Organ or haematologic transplant, or currently being evaluated for an organ transplant
* Women who are pregnant or breastfeeding

Where it's running

• Umcg
  Groningen, Netherlands Recruiting

Study contacts

• Principal investigator: Yuri Blaauw, Dr. — University Medical Center Groningen
• Study coordinator: Yuri Blaauw, Dr.
• Email: y.blaauw01@umcg.nl
• Phone: +31503616161

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Very high-power short-duration vs standard low-power radiofrequency ablation for atrial fibrillation

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• Pulsed Field Ablation Outcomes in Atrial Fibrillation: Randomized Comparison to Traditional Ablation

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• Comparing radiofrequency and cryoablation techniques for treating atrial fibrillation

  This study is testing whether radiofrequency or cryoablation works better for treating people with persistent atrial fibrillation who haven't had success with other treatments.

  Recruiting Bakulev Scientific Center of Cardiovascular Surgery · Moscow · NCT06253000

• Catheter ablation treatment for people with atrial fibrillation

  This project will try radiofrequency catheter ablation in adults with non-valvular atrial fibrillation to see if it improves atrial function and quality of life and to identify who is likely to have recurrence.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT05266144

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.