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Procedure

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

Must not have

Contraindication to systemic oral anticoagulation therapy or radiocontrast materials

Active intracardiac thrombus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 and 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had at least two episodes of AF in the last year.

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 or have dye used in medical imaging.

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I have a blood clot in my heart.

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I have ongoing and permanent atrial fibrillation.

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My kidney function is significantly reduced.

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I have had a procedure to correct an abnormal heart rhythm.

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My heart has a thickened wall greater than 1.8 cm.

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My heart condition severely limits my daily activities.

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My heart's pumping ability is significantly reduced.

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I have had surgery or ablation on the left side of my heart.

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I am willing and able to follow all study procedures.

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I have a serious heart valve problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Freedom from atrial fibrillation, atrial flutter or atrial tachycardia

Secondary study objectives

Ablation procedure duration

Atrial fibrillation burden

Emergency room visits or hospitalization due to recurrent AF, AFl or AT

+9 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: 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)

0 / 12Eligibility criteria met