Comparing two methods for treating atrial fibrillation
Lesion Formation With Pulsed Field Versus Cryobaloon Ablation as Assessed by Cardiac Magnetic Resoncance
This study is testing whether pulsed field ablation or cryoballoon ablation is a better way to treat atrial fibrillation in patients having this procedure for the first time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT06220006 on ClinicalTrials.gov |
What this trial studies
This randomized study compares pulsed field ablation and cryoballoon ablation in patients undergoing first-time atrial fibrillation catheter ablation. The focus is on assessing the quality of ablation lesions using late gadolinium enhancement cardiac magnetic resonance imaging three months post-ablation. Patients will be assigned in a 2:1 ratio to receive either pulsed field ablation or cryoballoon ablation for pulmonary vein isolation. The study aims to evaluate the efficacy and safety of these two ablation techniques.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for their first atrial fibrillation catheter ablation.
Not a fit: Patients with long-standing persistent atrial fibrillation or those who have had prior left atrial ablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients undergoing atrial fibrillation ablation.
How similar studies have performed: Previous studies have shown promising results for pulsed field ablation, indicating potential benefits over traditional methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for first-time atrial fibrillation catheter ablation Exclusion Criteria: * age \<18 years * long-standing persistent atrial fibrillation * prior left atrial ablation * pregnancy or lactation * reduced left ventricular ejection fraction * GFR \<30% * BMI \>35% * left atrial diameter \>55 mm * cardiac implantable electronic device
Where this trial is running
Barcelona, Catalonia
- Hospital Clinic, University of Barcelona — Barcelona, Catalonia, Spain (Recruiting)
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.