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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01260220
First received: June 8, 2010
Last updated: December 13, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention
Paroxysmal Atrial Fibrillation
 Procedure: Circumferential Antral Ablation
Procedure: Segmental Antral ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Segmental Versus Circumferential Antral Ablation in Paroxysmal Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Freedom from atrial fibrillation [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    Symptomatic atrial fibrillation recurrence (without anti-arrhythmic med's)


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    How long did the procedure take?

  • Ablation Time [ Time Frame: (4-6 hours) Measured during the procedure. ] [ Designated as safety issue: Yes ]
    A cumulative measurement of the duration of ablation used during the pulmonary vein isolation procedure.

  • Fluoroscopy Time [ Time Frame: (4-6 Hours) Measured during the procedure. ] [ Designated as safety issue: Yes ]
    A cumulative measurement of flouroscopy time during the pulmonary vein isolation procedure.

  • complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Did the patient experience any complication during the actual pulmonary vein isolation procedure or complication during follow-up related to the procedure?


Estimated Enrollment: 120
Study Start Date: November 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Circumferential
Completing a complete circle of RF lesions around the left and right pulmonary veins
 Procedure: Circumferential Antral Ablation
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.
Experimental: Segmental
Isolating the left and right pulmonary veins through RF lesions with a segmental antral approach.
 Procedure: Segmental Antral ablation
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260220

Contacts
Contact: Lorne J Gula, MD, MSc 519-663-3746 lgula@uwo.ca
Contact: Ellie C Hogg, BSc 519-685-8500 ext 32490 ellie.hogg@lhsc.on.ca

Locations
Canada, Ontario
London Health Science Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Lorne J Gula, MD, MSc     519-663-3746     lgula@uwo.ca    
Contact: Ellie Hogg, BSc     519-685-8500 ext 32490     ellie.hogg@lhsc.on.ca    
Sub-Investigator: Allan Skanes, MD,FRCPC            
Sub-Investigator: Peter Leong-Sit, MD,FRCPC            
Sub-Investigator: Raymond Sy, MD,FRCPC            
Sub-Investigator: Cathy Bently, BScN            
Sub-Investigator: Ellie Hogg, BSc            
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Lorne J Gula, MD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Dr. Lorne J. Gula, Assistant Professor of Medicine, Cardiology, London Health Science Centre
ClinicalTrials.gov Identifier: NCT01260220     History of Changes
Other Study ID Numbers: R-09-489
Study First Received: June 8, 2010
Last Updated: December 13, 2010
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013