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Procedure

Catheter Ablation 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
Must not have
Subjects with contraindication to systemic oral anticoagulation therapy, including a history of Heparin Induced Thrombocytopenia
Subjects with persistent or permanent AF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of the ablation procedure
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take blood thinners due to a bad reaction or other reasons.
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I have ongoing or permanent atrial fibrillation.
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I have had a procedure to treat atrial fibrillation.
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I have a serious heart valve problem.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of the ablation procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of the ablation procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to First Recurrence of any ECG documented AF, AFl or AT
Secondary study objectives
ECG documented AF
Health Economic Analysis
Quality of Life measurement using (EQ-5 and Canadian Cardiovascular Society-Severity of AF scales)
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
196 Previous Clinical Trials
93,286 Total Patients Enrolled
24 Trials studying Atrial Fibrillation
6,635 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

Media Library

Augmented-wide area circumferential ablation procedure (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02150902 — N/A
Atrial Fibrillation Research Study Groups: Augmented- WACA, WACA
Atrial Fibrillation Clinical Trial 2023: Augmented-wide area circumferential ablation procedure Highlights & Side Effects. Trial Name: NCT02150902 — N/A
Augmented-wide area circumferential ablation procedure (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02150902 — N/A
~29 spots leftby Sep 2025
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