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Personalized Catheter Ablation for Atrial Fibrillation (AWARE-2 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
Subjects must have Paroxysmal AF with at least two episodes of AF over the past 12 months; Early Persistent AF- at least two episodes of AF
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 months
Awards & highlights
AWARE-2 Trial Summary
This trial is testing a new method of performing a catheter ablation procedure to treat atrial fibrillation (AF). The new procedure is tailored to each individual patient, and the trial will evaluate whether it is more effective than the current standard of care in preventing AF recurrence. The trial will specifically evaluate the effectiveness and safety of the ablation procedure in women.
Who is the study for?
This trial is for adults who've had at least two episodes of a heart rhythm issue called Atrial Fibrillation in the past year. They must be able to consent and have no severe kidney disease, life expectancy under one year, or conditions like significant valve disease. Pregnant individuals or those with certain heart procedures or diseases are excluded.Check my eligibility
What is being tested?
The study compares two ways to treat Atrial Fibrillation: the standard ablation procedure versus a new patient-tailored method that uses individual-specific information to prevent AF recurrence. Participants will be randomly assigned to either treatment group.See study design
What are the potential side effects?
Potential side effects from the ablation procedures may include discomfort at the catheter insertion site, bleeding, heart tissue damage, blood vessel complications, and risks associated with anesthesia.
AWARE-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least two episodes of AF in the last year.
AWARE-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia
Secondary outcome measures
Ablation procedure duration
Atrial fibrillation burden
Emergency room visits or hospitalization due to recurrent AF, AFl or AT
+9 moreAWARE-2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RF based WACA ± EP testing guided ablation of non-PV triggers of AF and low voltage area ablationExperimental Treatment1 Intervention
Radiofrequency wide area circumferential ablation (WACA) ± electrophysiological testing guided ablation of non-pulmonary vein triggers of AF and low voltage area ablation
Group II: Cryoballoon ablationActive Control1 Intervention
Cryoballoon Pulmonary Vein Isolation-Wide area circumferential ablation (WACA)
Find a Location
Who is running the clinical trial?
University of British ColumbiaOTHER
1,419 Previous Clinical Trials
2,466,778 Total Patients Enrolled
9 Trials studying Atrial Fibrillation
1,434 Patients Enrolled for Atrial Fibrillation
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,046 Total Patients Enrolled
23 Trials studying Atrial Fibrillation
6,301 Patients Enrolled for Atrial Fibrillation
McGill UniversityOTHER
395 Previous Clinical Trials
998,987 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You already have paralysis in one side of your diaphragm.You have been diagnosed with certain heart rhythm problems before joining the trial.I do not have major birth-related heart issues, except for a patent foramen ovale.I cannot take blood thinners or have dye used in medical imaging.My atrial fibrillation isn't caused by conditions like untreated thyroid issues or recent heart surgery.I have a blood clot in my heart.I have ongoing and permanent atrial fibrillation.My kidney function is significantly reduced.I have had a procedure to correct an abnormal heart rhythm.I am on immunosuppressants but can stop them for 3 months before and after a procedure.My heart has a thickened wall greater than 1.8 cm.My heart condition severely limits my daily activities.I have had a stroke or a mini-stroke in the last 6 months.You have had a specific type of irregular heart rhythm confirmed by different heart monitoring tests.I have had at least two episodes of AF in the last year.My heart's pumping ability is significantly reduced.You have had a condition called pulmonary vein stenosis or have had a stent in one of your pulmonary veins in the past.You have experienced a bad reaction to adenosine in the past.I have had surgery or ablation on the left side of my heart.You are not expected to live for more than one year.I am willing and able to follow all study procedures.I am 18 years old or older.I have a serious heart valve problem.
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.
Research Study Groups:
This trial has the following groups:- Group 1: RF based WACA ± EP testing guided ablation of non-PV triggers of AF and low voltage area ablation
- Group 2: Cryoballoon ablation
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can members of the public now participate in this experiment?
"Unfortunately, enrollments for this trial have been closed. According to the information present on clinicaltrials.gov, it was first posted on July 1st 2022 and most recently updated in March 23rd 2022. Nevertheless, there are 478 other medical studies actively recruiting participants at this time."
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