NCT02150902Active, not recruiting
Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence
AUGMENTED WIDE AREA CIRCUMFERENTIAL CATHETER ABLATION FOR REDUCTION OF ATRIAL FIBRILLATION RECURRENCE - A RANDOMIZED CLINICAL TRIAL (The AWARE Trial)
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 411 (actual)
- First submitted
- 27 May 2014
- Start date
- 1 Mar 2015
- Primary completion date
- 27 Nov 2026
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Diseases
- Atrial fibrillation
- NCT number
- NCT02150902
What you commit to
- Study type: Interventional
- Participants enrolled: 411
- From 1 Mar 2015 to the primary completion date, 27 Nov 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous catheter or surgical ablation for AF
Other illness
- Subjects with contraindication to systemic oral anticoagulation therapy, including a history of Heparin Induced Thrombocytopenia
- Subjects with significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation)
- Subjects with congenital heart disease
Other
- Subjects with persistent or permanent AF
- Presence of known intracardiac thrombus
- Subjects with reversible causes of AF
- Subjects with known adverse reaction to adenosine
- Subjects that are pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Calgary Foothills Campus Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| QE II Health Sciences Centre Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| CIUSSSNIM-Hopital du Sacre-Coeur de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill University Health Center Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Institut universitaire de cardiologie et de pneumologie de Québec Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Centre hospitalier universitaire de Sherbrooke (CHUS) Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| Toronto General Hospital, University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Victoria Cardiac Arrhythmia Trials, Inc. Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.