A New Theory of Electrophysiological Mechanism of Atrial Fibrillation

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation
• Interventions: Procedure: PVI ablation; Procedure: PVI + SPEs ablation

• Registration Number: NCT05845034
• Lead Sponsor: The Second Affiliated Hospital of Kunming Medical University

Brief Summary

The electrophysiological mechanisms of atrial fibrillation remain disagreements. The goal of this clinical trail is to propose a new electrophysiological mechanism hypothesis of atrial fibrillation（AF）,meanwhile, the investigators sought to test the hypothesis that the superposition electrograms (SPEs) recorded during atrial fibrillation could be used as target sites for catheter ablation of atrial fibrillation.

Detailed Description

Catheter ablation for atrial fibrillation is a promising therapy, whose success is limited in part by uncertainty in the electrophysiological mechanisms of AF. The investigators recruited 100 subjects including paroxysmal(40%) and persistent (60%) AF. Cases were prospectively treated, in a 2-arm 1:1 design, by ablation SPEs followed by pulmonary vein isolation(PVI) ablation (n=50), or pulmonary vein isolation alone (n =50).

All procedures are guided by CARTO (Biosense Webster) electroanatomic mapping system and ablation is performed using open irrigated catheters with contact force (CF) sensing (Thermocool SmartTouch, Biosense Webster). Study Group underwent electroanatomic mapping during AF. Using CARTO to identify areas associated with SPEs. Radiofrequency ablation of the area with SPEs was performed, aiming to eliminate SPEs and convert to sinus rhythm or atrial tachycardia.

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-04-01
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-05-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-09
• Primary Completion: 2024-10-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients undergoing a first-time ablation procedure for AF
• Paroxysmal AF will be defined as a sustained episode lasting > 7 days; Persistent AF will be defined as a sustained episode lasting > 7 days and less than 1 years; Long-lasting persistent AF will be more than 1 year and less than 5 years.
• Patients must be willing and able to comply with all peri-ablation and follow-up requirements.
• Patients with atrial fibrillation will to accept the procedure of ablation.
• Patients signed the written informed consent for the study.
• Patients can endure the required follow up.

Exclusion Criteria

• Patients with contraindications to systemic anticoagulation with heparin or a direct thrombin inhibitor.
• Patients with thromboembolus in left atrial appendage.
• Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view).
• Patients allergic for contrast or iodine.
• Patients with the serum creatinine（SCr） >3.5mg/dl
• Patients with life expectancy < 12 months
• Patients who are in the period of pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	PVI ablation	Patients who undergo PVI alone using ThermoCool SmartTouch catheter.
With additional SPEs ablation	PVI + SPEs ablation	Patients who undergo PVI + SPEs ablation using ThermoCool SmartTouch catheter.

Primary Outcome Measures

Name	Time	Method
Freedom from AF during follow-up	one year	At the one-year follow-up，AF occurring in the first 3 months after the ablation (blanking period) were censored.Beyond this, any AF episode that lasted for more than 30 seconds was categorized as a recurrence.

Secondary Outcome Measures

Name	Time	Method
Acute success rate of AF termination during ablation procedure	one year	Conversion of AF to normal sinus rhythm or atrial tachyarrhythmias during ablation procedure.
Complications	one year	Serious adverse events included death, pericardial tamponade , cerebrovascular events, significant PV stenosis , left atrial-esophageal fistula.
freedom from documented AF/AT episode	one year	freedom from any documented AF/AT episode lasting \> 30 s after the blanking period without anti-arrhythmic drugs during the 12-month follow-up after a single procedure.

Trial Locations

Locations (1)

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