Comparing pulsed field ablation and radiofrequency ablation for repeat treatment of atrial fibrillation
Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat
This study is testing whether a new type of heart procedure called pulsed field ablation works better than the traditional method, radiofrequency ablation, for people with recurring atrial fibrillation who need another treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06199180 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a history of paroxysmal atrial fibrillation and documented recurrence after a previous pulmonary vein isolation.
Not a fit: Patients with persistent atrial fibrillation or those with other specific cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with recurrent atrial fibrillation, potentially reducing the risk of AF recurrence.
How similar studies have performed: While pulsed field ablation has shown promise in other contexts, this specific comparison with radiofrequency ablation for repeat PVI is novel and has not been previously tested in a randomized controlled trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Groningen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.