Randomized Trial of Segmental Versus Circumferential Antral Ablation in Paroxysmal Atrial Fibrillation

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Procedure: Circumferential Antral Ablation; Procedure: Segmental Antral ablation

• Registration Number: NCT01260220
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

An isolation-limited segmental antral approach to pulmonary vein isolation is as effective in achieving long-term freedom from atrial fibrillation as the standard anatomic, circumferential antral ablation.

Detailed Description

This is a randomized controlled non-inferiority designed trial.

Follow up:

Patients will stop their anti-arrhythmic drugs 2 months post procedure. Follow-ups will involve clinical assessment, holter and/or loop recorders at 3, 6, 9, and 12 month intervals.

Study Timeline

• Study Start: 2009-11-12
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-15
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Paroxysmal Atrial Fibrillation (PAF) for at least 6 months with at least 1 symptomatic episode during the previous 6 moths
• Patient must be felt to be candidates for Atrial Fibrillation (AF) ablation based on AF that is symptomatic and refractory or intolerant to at least one class 1 or 3 anti-arrhythmic agent
• Documentation of at least one episode of AF on 12 lead ECG, TTM or Holter monitor within 12 months of randomization in the trial
• Patient must be on continuous anti-coagulation with warfarin (INR 2-3) or fractionated subcutaneous heparin for >4 weeks prior to the ablation or they have undergone a recent (less than 48 hours before planned ablation) transoesphageal echocardiogram to exclude left atrial thrombus.
• Patient must provide written informed consent to participate in the clinical trial

Exclusion Criteria

• Contraindications to oral anticoagulants
• History of any previous ablation for AF
• Intracardiac thrombus
• AF due to reversible causes
• Pregnancy
• atriotomy scar (typically, MV or TV repair/replacement, ASD surgery, transplants)(CABG are okay)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Circumferential	Circumferential Antral Ablation	Completing a complete circle of RF lesions around the left and right pulmonary veins
Segmental	Segmental Antral ablation	Isolating the left and right pulmonary veins through RF lesions with a segmental antral approach.

Primary Outcome Measures

Name	Time	Method
Freedom from atrial fibrillation	six months	Symptomatic atrial fibrillation recurrence (without anti-arrhythmic med's)

Secondary Outcome Measures

Name	Time	Method
Procedure time	(4-6) hours From the time patient is draped to the time electrophysiology catheters are removed from the body (same day in the electrophysiology lab)	How long did the procedure take?
Ablation Time	(4-6 hours) Measured during the procedure.	A cumulative measurement of the duration of ablation used during the pulmonary vein isolation procedure.
Fluoroscopy Time	(4-6 Hours) Measured during the procedure.	A cumulative measurement of flouroscopy time during the pulmonary vein isolation procedure.
complications	6 months	Did the patient experience any complication during the actual pulmonary vein isolation procedure or complication during follow-up related to the procedure?

Trial Locations

Locations (1)

London Health Science Centre; 🇨🇦 London, Ontario, Canada