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OpenTrials
Completed

NCT Number: NCT01260220

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

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Science Centre

London, Ontario, N6A 5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Circumferential Antral Ablation

Procedure

The goal is to complete ablation in all segments around the pulmonary veins until a circle of ablation lesions is created in the antrum with at least 30 seconds of ablation, 25W on the posterior surface, 30W on the anterior surface at each site, and change in the local electrogram. Entry and Exit block will be confirmed in each vein. The left superior pulmonary vein and left inferior pulmonary vein will be isolated with one circle, and the right superior and right inferior pulmonary veins will be isolated with one circle.

Segmental Antral ablation

Procedure

If the patient is in atrial fibrillation, ablation will begin in the segment with the highest frequency signals in the pulmonary vein antrum. If the patient is in sinus rhythm, mapping and ablation will occur during coronary sinus pacing. Segments with the earliest signals in the Lasso catheter will be targeted, and reassessed after each ablation lesion. This will continue in a segmental fashion on the antrum until pulmonary vein isolation is achieved. Lasso should be moved between veins between lesions to assess the earliest electrogram. Entry and exit block will be confirmed at each vein.

Primary outcomes

  1. Freedom from atrial fibrillation

    Time frame: six months

    Symptomatic atrial fibrillation recurrence (without anti-arrhythmic med's)

Secondary outcomes

  1. Procedure time

    Time frame: (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?

  2. Ablation Time

    Time frame: (4-6 hours) Measured during the procedure.

    A cumulative measurement of the duration of ablation used during the pulmonary vein isolation procedure.

  3. Fluoroscopy Time

    Time frame: (4-6 Hours) Measured during the procedure.

    A cumulative measurement of flouroscopy time during the pulmonary vein isolation procedure.

  4. complications

    Time frame: 6 months

    Did the patient experience any complication during the actual pulmonary vein isolation procedure or complication during follow-up related to the procedure?

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Acronym: CABLE

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Dec 15, 2010
Registry last updated
Aug 28, 2017

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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