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Active, Not Recruiting

NCT Number: NCT05845034

A New Theory of Electrophysiological Mechanism of Atrial Fibrillation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PVI + SPEs ablation

Procedure

electrophysiology substrate mapping is the critical difference between both groups.

PVI Ablation

Procedure

electrophysiology substrate mapping is the critical difference between both groups.

Primary outcomes

  1. Freedom from AF during follow-up

    Time frame: 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 outcomes

  1. Acute success rate of AF termination during ablation procedure

    Time frame: one year

    Conversion of AF to normal sinus rhythm or atrial tachyarrhythmias during ablation procedure.

  2. Complications

    Time frame: one year

    Serious adverse events included death, pericardial tamponade , cerebrovascular events, significant PV stenosis , left atrial-esophageal fistula.

  3. freedom from documented AF/AT episode

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Kunming Medical University

Other

Registry information

Official study title

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

Acronym: ANTEMAF

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 6, 2023
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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