Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence (NCT02150902)
AUGMENTED WIDE AREA CIRCUMFERENTIAL CATHETER ABLATION FOR REDUCTION OF ATRIAL FIBRILLATION RECURRENCE - A RANDOMIZED CLINICAL TRIAL (The AWARE Trial)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Calgary-Foothills Campus — Calgary, Alberta
Age range: 18 Years
🧪 Interventions in This Study
- Wide area circumferential catheter ablation (PROCEDURE)
- Augmented- wide area circumferential ablation procedure (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- University of Calgary-Foothills Campus — Calgary, Alberta
- Victoria Cardiac Arrhythmia Trials Inc. — Victoria, British Columbia
- QE II Health Sciences Centre — Halifax, Nova Scotia
- University of Ottawa Heart Institute — Ottawa, Ontario
- St. Michael"s Hospital — Toronto, Ontario
- Toronto General Hospital-University Health Network — Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario
- McGill University Health Center — Montreal, Quebec
- CIUSSSNIM-Hopital du Sacre-Coeur de Montreal — Montreal, Quebec
- Institut universitaire de cardiologie et de pneumologie de Quebec — Québec, Quebec
- Centre hospitalier universitaire de Sherbrooke (CHUS) — Sherbrooke, Quebec
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Atrial Fibrillation
- CHAMPION-AF Clinical Trial — Birmingham, Alabama
- Reversal of Atrial Substrate to Prevent Atrial — Calgary, Alberta
- Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients — Rochester, New York
- REView of ProcEdural FactoRs and Outcomes After Atrial Fibrillation Ablation With Active Esophageal COOLing: A Sub-Study of the REAL AF Registry — Chandler, Arizona
- Targeting Risk Interventions and Metformin for Atrial Fibrillation (TRIM-AF) — Cleveland, Ohio
- Liraglutide Effect in Atrial Fibrillation — Miami, Florida
Explore by condition: All Atrial Fibrillation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.