Trial results for a study comparing tailored versus anatomical ablation strategies for persistent Atrial Fibrillation were posted on ClinicalTrials.gov on 2025-09-12. The tailored strategy showed 158 participants free from documented AF after one procedure, compared to 124 in the anatomical group, out of 377 total participants.
Background
Atrial Fibrillation (AF) is a common cardiac arrhythmia. Current ablation procedures for AF often involve Pulmonary Vein Isolation (PVI) in predefined anatomical regions of the left atrium. The study investigated whether a tailored ablation strategy, which targets patient-specific areas of spatio-temporal dispersion in addition to PVI, could offer superior outcomes compared to an anatomical ablation strategy focusing solely on PVI for the treatment of persistent AF.
Trial design
This completed study, designated as Phase NA, enrolled 377 participants with Atrial Fibrillation. The trial compared a tailored ablation strategy, which combined Pulmonary Vein Isolation (PVI) with targeting areas of spatio-temporal dispersion, against an anatomical ablation strategy that focused on PVI alone. The central hypothesis was that the tailored approach would be superior for treating persistent AF.
Key results
The trial reported several key measurements comparing the two ablation strategies:
- For the outcome "Number of Participants Free From Documented AF After One Ablation Procedure":
- The Tailored group had 158 participants.
- The Anatomical group had 124 participants.
- For the outcome "Number of Participants Free From Documented AF/AT After One or Two Ablation Procedures":
- The Tailored group had 136 participants.
- The Anatomical group had 126 participants.
- For the outcome "Number of Participants Free From Documented AF/AT After One Ablation Procedure":
- The Tailored group had 108 participants.
- The Anatomical group had 106 participants.
- Regarding safety, for the "Number of Participants With Complications (Safety Composite Endpoint)":
- The Tailored group had 8 participants.
- The Anatomical group had 5 participants.
What this means
The results indicate that a tailored ablation strategy may offer an advantage in achieving freedom from documented Atrial Fibrillation after a single procedure, with 158 participants in the tailored group remaining AF-free compared to 124 in the anatomical group. While the tailored approach also showed a slightly higher number of participants free from AF/AT after one or two procedures (136 vs. 126), and after one procedure (108 vs. 106), the differences were less pronounced. It is also noted that the tailored strategy was associated with a slightly higher number of participants experiencing complications (8 vs. 5) compared to the anatomical approach.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04702451, titled "Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation", were posted on 2025-09-12 on clinicaltrials.gov.