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

Lawson Health Research Institute

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: Circumferential Antral Ablation; Procedure: Segmental Antral ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT01260220

R-09-489

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Circumferential

Active Comparator group

Description:

Completing a complete circle of RF lesions around the left and right pulmonary veins

Treatment:

Procedure: Circumferential Antral Ablation

Segmental

Experimental group

Description:

Isolating the left and right pulmonary veins through RF lesions with a segmental antral approach.

Treatment:

Procedure: Segmental Antral ablation