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Procedure
Augmented- wide area circumferential ablation procedure for Atrial Fibrillation (AWARE Trial)
N/A
Waitlist Available
Led By Girish Nair, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of the ablation procedure
Awards & highlights
AWARE Trial Summary
This trial is comparing two techniques of AF catheter ablation to see if adding more ablation sites will help maintain normal heart rhythm and reduce the rate of return to AF.
Who is the study for?
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.Check my eligibility
What is being tested?
The study compares two catheter ablation techniques for treating abnormal heart rhythm due to AF: standard wide area circumferential ablation using adenosine and an experimental approach adding extra ablation without adenosine. The goal is to see if more ablation reduces recurrence of AF. Participants are randomly assigned into two groups and followed up at 3, 6 and 12 months post-procedure.See study design
What are the potential side effects?
Potential side effects include complications from catheter insertion like bleeding or infection; damage to the heart tissue causing other arrhythmias; reactions related to adenosine such as chest pain or shortness of breath; and risks associated with additional tissue destruction in the experimental group.
AWARE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
AWARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of the ablation procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of the ablation procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to First Recurrence of any ECG documented AF, AFl or AT
Secondary outcome measures
ECG documented AF
Health Economic Analysis
Quality of Life measurement using (EQ-5 and Canadian Cardiovascular Society-Severity of AF scales)
+5 moreAWARE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Augmented- WACAExperimental Treatment1 Intervention
Augmented- wide area circumferential catheter ablation for atrial fibrillation
Group II: WACAActive Control1 Intervention
Wide area circumferential catheter ablation procedure for atrial fibrillation
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Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,025 Total Patients Enrolled
23 Trials studying Atrial Fibrillation
6,280 Patients Enrolled for Atrial Fibrillation
Girish Nair, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
3 Previous Clinical Trials
630 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
590 Patients Enrolled for Atrial Fibrillation
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction to adenosine in the past.I am 18 years old or older.I cannot take blood thinners due to a bad reaction or other reasons.I have AFib that doesn't respond to or can't take certain heart rhythm medicines.I have ongoing or permanent atrial fibrillation.I have had a procedure to treat atrial fibrillation.My atrial fibrillation can be treated or reversed.You were born with a heart condition.I have a serious heart valve problem.
Research Study Groups:
This trial has the following groups:- Group 1: Augmented- WACA
- Group 2: WACA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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