Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence (AWARE)

April 29, 2026 updated by: Ottawa Heart Institute Research Corporation

AUGMENTED WIDE AREA CIRCUMFERENTIAL CATHETER ABLATION FOR REDUCTION OF ATRIAL FIBRILLATION RECURRENCE - A RANDOMIZED CLINICAL TRIAL (The AWARE Trial)

Atrial fibrillation (AF) is an abnormal heart rhythm in which the top chambers of the heart beat very fast. AF catheter ablation is a known technique to convert heart rhythm from AF to normal rhythm. The technique sends out electrical energy through a catheter (long thin round solid tubes) to destroy the heart tissues in a focused area where AF is starting. This technique is practiced at many hospitals, including the Heart Institute, and is not experimental.

The AWARE study will compare two techniques of AF catheter ablation:

  1. Ablation of tissues in wide circular bands around the opening of the pulmonary veins (bring blood back from lungs) in the left upper chamber of the heart. A medicine called adenosine will be given to unmask any incompletely ablated area. Additional ablations will be given if required. This is standard procedure.
  2. Same as above but adenosine will not be used. Instead, additional ablation of a second circular band of tissues around the opening of the pulmonary veins will be given. This additional ablation is not standard procedure and is considered experimental.

The Investigators are testing if adding more ablation sites will help maintain normal heart rhythm and reduce the rate of return to AF. The study will compare the occurrence of medical events and complications between the two groups.

Identical supplies and equipment used in both techniques have been approved by Health Canada. Adenosine is currently approved by Health Canada for the treatment and diagnosis of arrhythmias.

396 participants from study sites across Canada will be randomly assigned "similar to flipping a coin" to treatment group 1 or group 2.

After the ablation, participants will have study follow-up at 3, 6 and 12 months. All participant's will be followed for a minimum of 12 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Clinical relevance:

The problem of PV reconnection and recurrent AF after catheter ablation for paroxysmal AF is one of the important challenges faced by treating physicians.

Rationale:

The understanding of the role contact force plays in adequate lesion formation during catheter ablation and the fact that this may reduce pulmonary vein (PV) reconnection and AF recurrence is an exciting advance in the field of catheter ablation for AF. A few small clinical trials have demonstrated the safety and feasibility of contact force guided catheter ablation in reducing PV reconnection and AF recurrence. There is a clear need for well designed and adequately powered clinical trials to evaluate the effectiveness of this new strategy. The investigators have developed a novel "augmented" CF guided augmented ablation strategy and will test this against the current clinical gold standard ablation technique.

Objective:

Using contact force (CF) technology, our intention is to evaluate an "augmented- wide area circumferential catheter ablation strategy" that could potentially reduce the incidence of pulmonary vein reconnection and AF recurrence after catheter ablation in patients with paroxysmal AF.

Hypothesis:

In patients with symptomatic paroxysmal AF an augmented-wide area circumferential catheter ablation strategy will result in fewer electrocardiographically documented atrial arrhythmias (AF, atrial flutter and atrial tachycardia) recurrences compared to conventional wide-area catheter ablation.

All subjects in the control arm of the trial will undergo wide area circumferential catheter ablation (WACA; lesions delivered 1-2 cm away from the pulmonary vein ostium) around all four pulmonary veins to the endpoint of electrical isolation (demonstrated by entry and exit block using differential pacing). Catheter ablation will be performed using CF and VISITAG guidance (average CF >10g, Force time integral (FTI) > 500 g-sec and minimum ablation duration >10 sec). Dormant PV conduction will be tested using adenosine, after completion of the lesion set, and additional lesions will be delivered to eliminate dormant PV conduction.

In the experimental arm of the trial all subjects will undergo WACA as described above; however without adenosine testing. In addition these subjects will receive "augmented" ablation lesions, guided by CF feedback, on the outer aspect of the first WACA lesion set. Our hypothesis is that this "belts and suspender" strategy of redundant, CF guided antral ablation lesions will result in a wider band of irreversible atrial muscle and cardiac autonomic ganglionated-plexi damage. It is our expectation that the augmented WACA strategy will result in more durable PV isolation and thereby significantly reduce AF recurrence.

Trial Design:

This trial is a multicentre, prospective, randomized, blinded endpoint trial (PROBE) design. Subjects who satisfy the inclusion and exclusion criteria will be enrolled in the clinical trial. Subjects will be randomized (1:1) to either the control arm (WACA only) or the experimental arm (augmented- WACA). Patients randomized to the experimental arm will go on to have augmented-WACA. The first 90 days after catheter ablation will be considered a "blanking-period" and atrial tachyarrhythmias (AF, Atrial Flutter [AFl] or Atrial Tachycardia [AT]) occurring during this period will be documented. However, these will not be considered treatment failures. Patient accrual will occur over a 24-month period and each subject will have a minimum follow-up period of 12 months. The total duration of the trial will be 36-months (24 months for accrual and a minimum of 12 months of follow up for each subject). Patients will be followed at 3, 6, and 12 months, with 14 day continuous ambulatory ECG monitoring done at each follow up visit. A total of three questionnaires will be administered throughout the study, each at a specific time point. The Quality of Life (EQ-5D) and CCS-Severity of AF scale will be completed together, prior to ablation and at the final follow-up visit. The patient satisfaction score will be completed at the final follow-up visit. All participants will be followed for a minimum of 12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
411

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary-Foothills Campus
    • British Columbia
      • Victoria, British Columbia, Canada, V8T 1Z4
        • Victoria Cardiac Arrhythmia Trials Inc.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QE II Health Sciences Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael"s Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital-University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Center
      • Montreal, Quebec, Canada, H4J 1C5
        • CIUSSSNIM-Hopital du Sacre-Coeur de Montreal
      • Québec, Quebec, Canada, G1V 4G5
        • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre hospitalier universitaire de Sherbrooke (CHUS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years
  2. Subjects must have symptomatic Paroxysmal AF that is refractory to at least one class I or Class III antiarrhythmic medication OR be intolerant of antiarrhythmic medications OR prefer not to trial antiarrhythmic medications
  3. At least one episode of AF documented on 12-lead ECG, Holter monitor or Loop recorder.
  4. Subjects must be able to provide informed consent

Exclusion Criteria:

  1. Subjects with persistent or permanent AF
  2. History of previous catheter or surgical ablation for AF
  3. Presence of known intracardiac thrombus
  4. Subjects with contraindication to systemic oral anticoagulation therapy, including a history of Heparin Induced Thrombocytopenia
  5. Subjects with reversible causes of AF
  6. Subjects with significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation)
  7. Subjects with known adverse reaction to adenosine
  8. Subjects with congenital heart disease
  9. Subjects that are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Augmented- WACA
Augmented- wide area circumferential catheter ablation for atrial fibrillation
Procedure: Augmented- wide area circumferential ablation procedure
Subjects in this group will have WACA performed as described for WACA. Following completion of the WACA procedure a second set of circumferential ablation lesions will be delivered around the first set of ablation lesions. The ablation catheter tip will be positioned at each of the ablation lesions along the first WACA line and then moved away (from the PV ostia) until healthy, non ablated tissue is recorded from the catheter tip. Energy will be delivered using CF and FTI data as described previously. Once the first WACA ablation line has been completely duplicated the procedure will be deemed complete. In case PV isolation is not achieved after the first WACA lesion set repeat electrophysiologic testing will be performed to determine whether the augmented-WACA procedure was successful in achieving PV isolation.
Other Names:
  • Augmented WACA
Active Comparator: WACA
Wide area circumferential catheter ablation procedure for atrial fibrillation
Procedure: Wide area circumferential catheter ablation
All subjects in the control arm of the trial will undergo wide area circumferential catheter ablation (WACA; lesions delivered 1-2 cm away from the pulmonary vein ostium) around all four pulmonary veins to the endpoint of electrical isolation (demonstrated by entry and exit block using differential pacing). Catheter ablation will be performed using contact force (CF) and electroanatomical mapping system guidance (average CF >10g, FTI > 500 g-sec and minimum ablation duration >10 sec). Dormant pulmonary vein conduction will be tested using adenosine, after completion of the lesion set, and additional lesions will be delivered to eliminate dormant PV conduction.
Other Names:
  • WACA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to First Recurrence of any ECG documented AF, AFl or AT
Time Frame: between days 91 and 364 after catheter ablation
Time to first recurrence of any ECG documented AF, AFl or AT (symptomatic or asymptomatic) occurring between days 91 and 364 after catheter ablation in the absence of Class I or III antiarrhythmic drug therapy.
between days 91 and 364 after catheter ablation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ECG documented AF
Time Frame: during the first 90 days after catheter ablation
Incidence of any ECG documented AF (symptomatic or asymptomatic) during the first 90 days after catheter ablation
during the first 90 days after catheter ablation
emergency department visits or hospitalizations
Time Frame: from randomization to day 364
The need for emergency department visits or hospitalizations
from randomization to day 364
procedure related complications
Time Frame: from ablation to day 364
Composite safety endpoints- procedure related complications (Stroke, PV stenosis, Pericarditis, Cardiac perforation, Atrio-esophageal fistula, Major bleeding) and/or death.
from ablation to day 364
Total procedure duration
Time Frame: day of the ablation procedure
total ablation procedure duration in minutes
day of the ablation procedure
Total radiation exposure during the procedure
Time Frame: day of the ablation procedure
Dose area product in McGy.cm2 and cumulative skin dose in mGv
day of the ablation procedure
Health Economic Analysis
Time Frame: from randomization to day 364
Health care related costs
from randomization to day 364
The need for repeat catheter ablation procedure
Time Frame: days 91 and 364 after catheter ablation
The need for repeat catheter ablation procedure because of documented recurrence of symptomatic AF, AFl or AT
days 91 and 364 after catheter ablation
Quality of Life measurement using (EQ-5 and Canadian Cardiovascular Society-Severity of AF scales)
Time Frame: from randomization to day 364
Quality of Life (EQ-5 and Canadian Cardiovascular Society-Severity of AF scales)
from randomization to day 364

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Heart Institute Research Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Girish Nair, MD, Ottawa Heart Institute Research Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRIS 2771
  • 201610PJT-376677 (Other Grant/Funding Number: CIHR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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