A New Theory of Electrophysiological Mechanism of Atrial Fibrillation (ANTEMAF)

Kunming Medical University

Status: Active, not recruiting

Conditions: Atrial Fibrillation

Treatments: Procedure: PVI + SPEs ablation; Procedure: PVI ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05845034

CASE2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

With additional SPEs ablation

Experimental group

Description:

Patients who undergo PVI + SPEs ablation using ThermoCool SmartTouch catheter.

Treatment:

Procedure: PVI + SPEs ablation

Control Group

Active Comparator group

Description:

Patients who undergo PVI alone using ThermoCool SmartTouch catheter.

Treatment:

Procedure: PVI ablation