A New Theory of Electrophysiological Mechanism of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— ANTEMAF  

Official title:

A New Theory of Electrophysiological Mechanism of Atrial Fibrillation and Catheter Ablation Therapy for Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05845034
• Other study ID #: CASE2022
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: The Second Affiliated Hospital of Kunming Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• PVI + SPEs ablation
electrophysiology substrate mapping is the critical difference between both groups.
• PVI ablation
electrophysiology substrate mapping is the critical difference between both groups.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Kunming Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659- — View Citation

Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. — View Citation

Narayan SM, Krummen DE, Shivkumar K, Clopton P, Rappel WJ, Miller JM. Treatment of atrial fibrillation by the ablation of localized sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) trial. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from AF during follow-up	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.	one year
Secondary	Acute success rate of AF termination during ablation procedure	Conversion of AF to normal sinus rhythm or atrial tachyarrhythmias during ablation procedure.	one year
Secondary	Complications	Serious adverse events included death, pericardial tamponade , cerebrovascular events, significant PV stenosis , left atrial-esophageal fistula.	one year
Secondary	freedom from documented AF/AT episode	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.	one year