Predicting Recurrence of Atrial Fibrillation After Ablation
Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal Atrial Fibrillation Undergoing First Transcatheter Ablation Procedure of Atrial Fibrillation by Pulmonary Vein Isolation
This study is trying to find out which factors can help predict if people with paroxysmal atrial fibrillation will have their heart rhythm problems come back after their first ablation treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Centro Cardiologico Monzino Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Ancona and 1 other locations) |
| Trial ID | NCT06085014 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify clinical and electrophysiological predictors of arrhythmic recurrence in patients with paroxysmal atrial fibrillation (AF) undergoing their first ablation procedure through pulmonary vein isolation. By examining baseline clinical variables and the left atrial substrate, the study seeks to determine which factors may influence the success rate of the ablation procedure. The research will involve both prospective and retrospective data collection across multiple centers to enhance the understanding of patient outcomes following AF ablation.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a clinical indication for atrial fibrillation ablation who are on adequate anticoagulation therapy.
Not a fit: Patients who have previously undergone an AF ablation procedure or have significant cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients who are more likely to benefit from ablation, potentially improving treatment outcomes for those with paroxysmal AF.
How similar studies have performed: Other studies have explored predictors of success in AF ablation, but this specific approach focusing on baseline clinical and electrophysiological features is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with indication for AF ablation * Adequate anticoagulation therapy according to CHADs VASC Exclusion Criteria: * patients who had already undergo an AF ablation procedure * Presence of intracavitary thrombus * Ejection fraction \<35% * Pregnancy * Hematologic contraindications to ionizing radiation exposure * Congenital heart diseases * Cardiac Surgery \< 1month * Uncontrolled heart failure * Valvular disease * Contraindications to general anesthesia
Where this trial is running
Ancona and 1 other locations
- Azienda Ospedaliera Universitaria delle Marche — Ancona, Italy (Not_yet_recruiting)
- IRCCS Centro Cardiologico Monzino — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Stefania Riva, MD — IRCCS Centro Cardiologico Monzino
- Study coordinator: Stefania Riva, MD
- Email: stefania.riva@cardiologicomonzino.it
- Phone: 02 58002584
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.