Clinical trial NCT05845034: A New Theory of Electrophysiological Mechanism of Atrial Fibrillation
Official title: A New Theory of Electrophysiological Mechanism of Atrial Fibrillation and Catheter Ablation Therapy for Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: The Second Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Freedom from AF during follow-up
timeFrame: one year
Secondary outcomes:
measure: Acute success rate of AF termination during ablation procedure
timeFrame: one year
measure: Complications
timeFrame: one year
measure: freedom from documented AF/AT episode
timeFrame: one year
Other outcomes:
Locations:
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: The Second Affiliated Hospital of Kunming Medical University
name: Mingli Zhou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):659-66. doi: 10.1056/NEJM199809033391003.
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. doi: 10.1016/j.jacc.2003.12.054.
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. J Am Coll Cardiol. 2012 Aug 14;60(7):628-36. doi: 10.1016/j.jacc.2012.05.022. Epub 2012 Jul 18.