Ablation procedure for persistent atrial fibrillation using advanced mapping techniques
Driver-guided Ablation in the Treatment of Persistent Atrial Fibrillation
This study is testing a new mapping technique during an ablation procedure to see if it can help people with persistent atrial fibrillation feel better and reduce their symptoms over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 181 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milano) |
| Trial ID | NCT04085731 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enroll 181 patients with persistent atrial fibrillation (AF) to evaluate a novel integrated 3D mapping technique for identifying arrhythmic substrates. The ablation procedure will target areas with fast electrical activities and potential arrhythmia circuits, followed by standard circumferential pulmonary vein ablation (CPVA). The study will assess the effectiveness of this mechanism-targeted approach in improving clinical outcomes and reducing AF recurrence over a 12-month follow-up period. Participants will be monitored using implantable loop recorders or telephonic ECG recordings to track arrhythmia recurrence.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-85 with persistent atrial fibrillation who are undergoing their first or second ablation procedure.
Not a fit: Patients with secondary atrial fibrillation, significant comorbidities, or contraindications to anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment of persistent atrial fibrillation, potentially reducing recurrence rates and improving patient outcomes.
How similar studies have performed: While this approach utilizes novel mapping techniques, similar studies have shown promise in improving outcomes for atrial fibrillation ablation, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age (18-85 years), persistent AF according to ESC/EHRA guidelines, first or second ablation procedure, ability to provide informed written consent. - Exclusion Criteria: Secondary AF, Hyperthyroidism, LVEF\<30%, NYHA functional class IV, uncorrected valvular heart diseases, contraindication to anticoagulation, left atrial thrombus, recent (\<6 months) myocardial infarction, thoracic surgery for congenital, valvular diseases, History of cerebrovascular events, pregnancy, cancer or other significant comorbidities. -
Where this trial is running
San Donato Milanese, Milano
- IRCCS Policlinico S. Donato — San Donato Milanese, Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Carlo Pappone, MD — IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
- Study coordinator: Carlo Pappone, MD
- Email: carlo.pappone@af-ablation.org
- Phone: +39 02 52774260
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.