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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Circumferential Antral Ablation
Segmental Antral ablation
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • London Health Science Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Circumferential

Segmental

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Procedure time
How long did the procedure take?
Ablation Time
A cumulative measurement of the duration of ablation used during the pulmonary vein isolation procedure.
Fluoroscopy Time
A cumulative measurement of flouroscopy time during the pulmonary vein isolation procedure.
complications
Did the patient experience any complication during the actual pulmonary vein isolation procedure or complication during follow-up related to the procedure?

Full Information

First Posted
June 8, 2010
Last Updated
August 25, 2017
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01260220
Brief Title
Randomized Trial of Segmental Versus Circumferential Antral Ablation in Paroxysmal Atrial Fibrillation
Acronym
CABLE
Official Title
Randomized Trial of Segmental Versus Circumferential Antral Ablation in Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 12, 2009 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
December 31, 2015 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Circumferential
Arm Type
Active Comparator
Arm Description
Completing a complete circle of RF lesions around the left and right pulmonary veins
Arm Title
Segmental
Arm Type
Experimental
Arm Description
Isolating the left and right pulmonary veins through RF lesions with a segmental antral approach.
Intervention Type
Procedure
Intervention Name(s)
Circumferential Antral Ablation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Segmental Antral ablation
Intervention Description
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 Outcome Measure Information:
Title
Freedom from atrial fibrillation
Description
Symptomatic atrial fibrillation recurrence (without anti-arrhythmic med's)
Time Frame
six months
Secondary Outcome Measure Information:
Title
Procedure time
Description
How long did the procedure take?
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)
Title
Ablation Time
Description
A cumulative measurement of the duration of ablation used during the pulmonary vein isolation procedure.
Time Frame
(4-6 hours) Measured during the procedure.
Title
Fluoroscopy Time
Description
A cumulative measurement of flouroscopy time during the pulmonary vein isolation procedure.
Time Frame
(4-6 Hours) Measured during the procedure.
Title
complications
Description
Did the patient experience any complication during the actual pulmonary vein isolation procedure or complication during follow-up related to the procedure?
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorne J Gula, MD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Science Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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