NCT06694610

A Study on the Relationship Between Individualized Low Voltage Regions in Left Atrium and the Mechanism of Atrial Fibrillation in Persistent Atrial Fibrillation Under Ultra-High-Resolution Mapping

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The Third People's Hospital of Chengdu · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The latest OCTARAY multi-electrode mapping catheter and TUREref technology were used to perform ultra-high precision mapping on the left atrial and left atrial auricle of persistent atrial fibrillation in the condition of sinus rhythm and atrial fibrillation respectively, and the density and accuracy of potential were significantly improved. According to the mapping results, the numerical calculation of the personalized low voltage region was carried out, and the personalized ablation route was designed according to the low voltage region.

Detailed description

1. The latest OCTARAY multi-electrode mapping catheter and TUREref technology were used to perform ultra-high precision mapping on the left atrial and left atrial auricle of persistent atrial fibrillation in the condition of sinus rhythm and atrial fibrillation respectively, and the density and accuracy of potential were significantly improved. According to the mapping results, the numerical calculation of the personalized low voltage region was carried out, and the personalized ablation route was designed according to the low voltage region. 2. Octaray multi-electrode mapping catheter and CartoFinder software were used to map focal drive and reentrant ring in left atrial fibrillation. Based on the CartoFinder software's mapping of focal drive and normal potential areas, potential analysis was used to find the reentrant ring of persistent AF. The ablation route of the reentry ring is designed. 3. Based on the designed ablation route, it is divided into different ablation route groups. They were divided into two groups: treatment of pulmonary vein ablation route only; Treatment of non-pulmonary venous ablation route group. In the group treated with only pulmonary vein ablation route, only potential isolation of pulmonary vein was performed, and bidirectional block was the end point. In the non-pulmonary vein ablation group, pulmonary vein isolation was not allowed, but the left atrial low-voltage area was treated first, and then the ablation route that terminated the reentry ring was treated. In the low-voltage region ablation group, if there was a large difference between the low-voltage region in atrial fibrillation and the low-voltage region in sinusional state, there was a common low-voltage region and a non-common low-voltage region. The non-common low-voltage region refers to the region with low voltage region in atrial fibrillation and no low voltage region in sinusional state. This type of cases were divided into two subgroups, A and B. Group A preferentially ablated the non-common low voltage region, group B preferentially ablated the common low voltage region. In the condition of atrial fibrillation, if there is overlap between the low-voltage ablation line and the reentrant ablation line in the non-pulmonary vein ablation group, the overlap line should be abated preferentially. 4. In each group, the atrial fibrillation was attributed to the maintenance factor group according to the region of transsinus ablation or the region of atrial flutter tachycardia ablation. Pulmonary vene-associated atrial fibrillation, low-voltage region associated atrial fibrillation, reentrant ring associated atrial fibrillation. 5. The intraoperative ablation data of each group were analyzed, such as ablation number, time, stopping site, and follow-up sinus rhythm maintenance rate. "Follow-up times are at 3 months, 6 months, and 12 months post-surgery. "Monitoring heart rhythm through the use of 7-day ambulatory Holter monitoring."

Conditions

• Atrial Fibrillation Recurrent

Interventions

Type	Name	Description
PROCEDURE	non-pulmonary vein ablation group	In the non-pulmonary vein ablation group, pulmonary vein isolation was not allowed, but the left atrial low-voltage area was treated first, and then the ablation route that terminated the reentry ring was treated.
PROCEDURE	only pulmonary vein ablation group	In the group treated with only pulmonary vein ablation route, only potential isolation of pulmonary vein was performed, and bidirectional block was the end point.

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-04-05
• Completion: 2026-04-05
• First posted: 2024-11-19
• Last updated: 2024-11-19

Regulatory

• FDA-regulated device study