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

NCT01260220 | Completed DMC

• 1 other identifier: R-09-489
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial fibrillation

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

  six months

Secondary Outcomes (4)

• 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)

• Ablation Time

  (4-6 hours) Measured during the procedure.

• Fluoroscopy Time

  (4-6 Hours) Measured during the procedure.

• complications

  6 months

Study Arms (2)

Circumferential

ACTIVE COMPARATOR

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

Procedure: Circumferential Antral Ablation

Segmental

EXPERIMENTAL

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

Procedure: Segmental Antral ablation

Interventions

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.

Circumferential

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.

Segmental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

London Health Science Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lorne J Gula, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: December 15, 2010
• Study Start: November 12, 2009
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CA (1)