NCT02150902

Brief Summary

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. 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
6mo left

Started Mar 2015

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Mar 2015Nov 2026

First Submitted

Initial submission to the registry

May 27, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

11.8 years

First QC Date

May 27, 2014

Last Update Submit

April 29, 2026

Conditions

Atrial Fibrillation

Keywords

Catheter ablation for atrial fibrillationtreatment for atrial fibrillationcomparison of catheter ablation techniques for atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Time to First Recurrence of any ECG documented AF, AFl or AT

    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 Outcomes (8)

  • The need for repeat catheter ablation procedure

    days 91 and 364 after catheter ablation

  • ECG documented AF

    during the first 90 days after catheter ablation

  • emergency department visits or hospitalizations

    from randomization to day 364

  • procedure related complications

    from ablation to day 364

  • Quality of Life measurement using (EQ-5 and Canadian Cardiovascular Society-Severity of AF scales)

    from randomization to day 364

  • +3 more secondary outcomes

Study Arms (2)

Augmented- WACA

EXPERIMENTAL

Augmented- wide area circumferential catheter ablation for atrial fibrillation

Procedure: Augmented- wide area circumferential ablation procedure

WACA

ACTIVE COMPARATOR

Wide area circumferential catheter ablation procedure for atrial fibrillation

Procedure: Wide area circumferential catheter ablation

Interventions

Wide area circumferential catheter ablationPROCEDURE

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.

Also known as: WACA
WACA
Augmented- wide area circumferential ablation procedurePROCEDURE

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.

Also known as: Augmented WACA
Augmented- WACA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • 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
  • At least one episode of AF documented on 12-lead ECG, Holter monitor or Loop recorder.
  • Subjects must be able to provide informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Calgary-Foothills Campus

Calgary, Alberta, T2N 4Z6, Canada

Location

Victoria Cardiac Arrhythmia Trials Inc.

Victoria, British Columbia, V8T 1Z4, Canada

Location

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St. Michael"s Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital-University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Location

CIUSSSNIM-Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Quebec

Québec, Quebec, G1V 4G5, Canada

Location

Centre hospitalier universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (2)

  • Nair GM, Birnie DH, Nery PB, Redpath CJ, Sarrazin JF, Roux JF, Parkash R, Bernier M, Sterns LD, Sapp J, Novak P, Veenhuyzen G, Morillo CA, Singh SM, Sadek MM, Golian M, Klein A, Sturmer M, Chauhan VS, Angaran P, Green MS, Bernick J, Wells GA, Essebag V. Standard vs Augmented Ablation of Paroxysmal Atrial Fibrillation for Reduction of Atrial Fibrillation Recurrence: The AWARE Randomized Clinical Trial. JAMA Cardiol. 2023 May 1;8(5):475-483. doi: 10.1001/jamacardio.2023.0212.

    PMID: 36947030DERIVED

  • Nair GM, Birnie DH, Wells GA, Nery PB, Redpath CJ, Sarrazin JF, Roux JF, Parkash R, Bernier M, Sterns LD, Novak P, Veenhuyzen G, Morillo CA, Singh SM, Sturmer M, Chauhan VS, Angaran P, Essebag V. Augmented wide area circumferential catheter ablation for reduction of atrial fibrillation recurrence (AWARE) trial: Design and rationale. Am Heart J. 2022 Jun;248:1-12. doi: 10.1016/j.ahj.2022.02.009. Epub 2022 Feb 24.

    PMID: 35219715DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Girish Nair, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2014

First Posted

May 30, 2014

Study Start

March 1, 2015

Primary Completion (Estimated)

November 27, 2026

Study Completion (Estimated)

November 27, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

CA(11)