Catheter Ablation for Atrial Fibrillation
(AWARE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two methods of performing catheter ablation to treat atrial fibrillation (AF), a condition where the heart beats irregularly and too fast. The researchers aim to determine if adding extra ablation (destroying small areas of heart tissue) helps maintain a normal heart rhythm and reduces AF episodes. Participants will be divided into two groups: one will receive a standard procedure called wide area circumferential catheter ablation, while the other will undergo an experimental procedure known as the augmented-wide area circumferential ablation. Individuals who have experienced troublesome AF episodes and have not found relief from certain medications might be suitable for this study. Researchers will monitor participants for at least a year to track progress and any side effects. As an unphased trial, this study offers participants the chance to explore innovative treatment options that could improve their heart health.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, since participants must have AF that is not controlled by certain medications or cannot tolerate them, you might need to discuss your current medications with the study team.
What prior data suggests that these catheter ablation techniques are safe for atrial fibrillation?
Research shows that catheter ablation for atrial fibrillation (AF) is generally well-tolerated. One study found that serious complications from AF ablation have decreased over time, suggesting the procedure is becoming safer as techniques improve.
Earlier studies have examined the safety and effectiveness of augmented-wide area circumferential ablation, comparing this new approach to the standard method. The results showed that both methods work well, and the new technique does not significantly increase risks.
Adenosine, used in the standard ablation procedure, is already approved for treating and diagnosing irregular heartbeats, indicating its well-established safety. Both procedures in the trial use equipment and supplies approved by Health Canada, further supporting their safety.12345Why are researchers excited about this trial?
Researchers are excited about the catheter ablation techniques being explored for atrial fibrillation because they offer potentially enhanced precision and effectiveness. The augmented-wide area circumferential ablation (WACA) is distinctive because it expands the treatment area, potentially leading to more comprehensive targeting of the heart tissue responsible for irregular heartbeats. Unlike the standard wide area circumferential catheter ablation, which is already a common procedure, the augmented approach aims to improve outcomes by reducing the likelihood of arrhythmia recurrence. This could mean fewer repeat procedures and better long-term results for patients.
What evidence suggests that this trial's treatments could be effective for atrial fibrillation?
Research has shown that catheter ablation effectively treats atrial fibrillation (AF), a condition where the heart beats irregularly. This procedure uses a thin tube to deliver electrical energy to specific heart areas, destroying the tissue causing the irregular heartbeat. The usual technique involves creating a circular line around the pulmonary veins to restore a normal heart rhythm. Studies have found that with current methods, about 33% to 40% of patients may experience AF recurrence within a year. In this trial, one group will receive the standard wide area circumferential catheter ablation (WACA), while another group will receive an augmented version of this procedure. The new experimental approach adds an extra line of ablation without using the drug adenosine to see if it lowers the chance of AF recurrence. However, previous studies showed that this additional ablation does not significantly reduce AF recurrence compared to the standard method.12467
Who Is on the Research Team?
Girish Nair, MD
Principal Investigator
Ottawa Heart Institute Research Corporation
Are You a Good Fit for This Trial?
This trial is for adults over 18 with symptomatic Paroxysmal Atrial Fibrillation (AF) that's not responding to certain medications, or those who can't tolerate or prefer not to use these drugs. Participants must have had at least one AF episode confirmed by ECG and be able to consent. It excludes individuals with reversible causes of AF, significant heart valve disease, known clots in the heart, pregnancy, adverse reactions to adenosine, persistent/permanent AF, previous ablations for AF or those who can't take blood thinners.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo wide area circumferential catheter ablation (WACA) with or without augmented ablation lesions
Blinding Period
Atrial tachyarrhythmias occurring during this period will be documented but not considered treatment failures
Follow-up
Participants are monitored for safety and effectiveness after treatment with follow-up visits at 3, 6, and 12 months
What Are the Treatments Tested in This Trial?
Interventions
- Augmented-wide area circumferential ablation procedure
- Wide area circumferential catheter ablation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Heart Institute Research Corporation
Lead Sponsor