A New Approach for Catheter Ablation of Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: PVI + SPs ablation; Procedure: PVI alone

• Registration Number: NCT05989321
• Lead Sponsor: The Second Affiliated Hospital of Kunming Medical University

Brief Summary

This is a retrospective cohort study of radiofrequency ablation for the treatment atrial fibrillation(AF). Based on the electrophysiological phenomena found in these cases, the investigators propose a hypothesis regarding the underlying electrophysiological mechanism of AF, as well as a novel approach for catheter ablation of AF.

Detailed Description

The investigators propose a new electrophysiological mechanism for AF: the superposition hypothesis. The investigators tested this hypothesis by conducting the retrospective cohort study to determine if superposition potentials (SP) can identify the critical regions where AF is sustained and if ablating SPs can improves the long-term efficacy.

The study consecutively collected patients with underwent the first catheter ablation for symptomatic AF in a university hospital from March 2021 to June 2022, including paroxysmal AF (lasting \<7 days), persistent AF (lasting \>7 days and \<1 year without electrical cardioversion) and long-term persistent AF (lasting \>1 year), aged between 18 and 80 years old. AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at each clinic visit. The eligible patients were divided into two groups: the pulmonary vein isolation(PVI) alone group (n=56) and the PVI + SPs ablation group(n=60).Comprehensive clinical history and procedural data of patients were collected from electronic medical records.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-15
• Status Verified: 2023-08
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-03
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• patients with underwent the first catheter ablation for symptomatic AF

Exclusion Criteria

• patients with more than one missing follow-up would be excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PVI + SPs ablation group	PVI + SPs ablation	Patients who undergo PVI + SPs ablation using ThermoCool SmartTouch catheter.
PVI alone group	PVI alone	Patients who undergo PVI alone using ThermoCool SmartTouch catheter.

Primary Outcome Measures

Name	Time	Method
freedom from AF within 12 months	12 months	AF recurrence was evaluated at 3, 6, 9, and 12 months using 72-hour Holter monitoring at each clinic visit. AF recurrence was defined as the occurrence of AF lasting at least 30 seconds after the 3-month blanking period.

Secondary Outcome Measures

Name	Time	Method
the acute termination of AF during the procedure	during the procedure	Conversion of AF to normal sinus rhythm or atrial tachyarrhythmias during ablation procedure.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China