Monitoring early and late recurrences of atrial fibrillation after a specific ablation procedure
Early Recurrences of Atrial Arrhythmias and Their Impact on Late Recurrence After Pulmonary Vein Isolation With Pulsed Field Ablation of Paroxysmal Atrial Fibrillation
This study is testing how well a new heart procedure called pulsed field ablation works for people with atrial fibrillation by using a special device to monitor their heart rhythm for any early or late returns of the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Split, School of Medicine Academic / other |
| Locations | 1 site (Split, Splitsko-dalmatinska) |
| Trial ID | NCT05328882 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with symptomatic paroxysmal atrial fibrillation who undergo pulsed field ablation (PFA). Participants will have an implantable loop recorder placed immediately after the procedure to monitor their heart rhythm. The study aims to categorize early recurrences of atrial fibrillation into very early (up to 1 month) and early (1-3 months) recurrences, while late recurrences will be tracked from 3 to 12 months post-procedure. Regular follow-up visits will be conducted to assess symptoms and gather data on arrhythmia burden using the loop monitor.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with symptomatic paroxysmal atrial fibrillation who have not responded to or tolerated antiarrhythmic drugs.
Not a fit: Patients with contraindications to ablation, persistent or permanent atrial fibrillation, or those with secondary AF due to reversible causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of atrial fibrillation recurrence patterns, leading to better management strategies for patients.
How similar studies have performed: While this approach is novel in its specific focus on early and late recurrence monitoring post-PFA, similar studies have shown promise in understanding arrhythmia recurrence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 * Index PFA procedure after one failed or intolerant group I or III of the antiarrhythmic drug in patients with symptomatic paroxysmal AF (AF with self-terminating episodes lasting no longer than 7 continuous days) * Willing and able to provide informed consent. Exclusion Criteria: * Any known contraindication to AF ablation or anticoagulation. * History of previous left atrial ablation or surgical treatment. * Secondary AF due to reversible or non-cardiac cause such as thyroid disease and electrolyte imbalance. * Asymptomatic AF patients, persistent AF, permanent AF patients. * History of clotting or bleeding disease or cryoglobulinemia. * Pregnant or lactating. * Other conditions that may make the patient a poor candidate for procedure such as mental illness, terminal illness, vulnerable patient population.
Where this trial is running
Split, Splitsko-dalmatinska
- University Hospital Center Split — Split, Splitsko-dalmatinska, Croatia (Recruiting)
Study contacts
- Study coordinator: Lucija Lisica, MD
- Email: lucijalisica21@gmail.com
- Phone: +385995094697
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.