Catheter Ablation for Atrial Fibrillation
(AWARE Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byGirish Nair, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ottawa Heart Institute Research Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?Atrial fibrillation (AF) is an abnormal heart rhythm in which the top chambers of the heart beat very fast. AF catheter ablation is a known technique to convert heart rhythm from AF to normal rhythm. The technique sends out electrical energy through a catheter (long thin round solid tubes) to destroy the heart tissues in a focused area where AF is starting. This technique is practiced at many hospitals, including the Heart Institute, and is not experimental. The AWARE study will compare two techniques of AF catheter ablation: 1. Ablation of tissues in wide circular bands around the opening of the pulmonary veins (bring blood back from lungs) in the left upper chamber of the heart. A medicine called adenosine will be given to unmask any incompletely ablated area. Additional ablations will be given if required. This is standard procedure. 2. Same as above but adenosine will not be used. Instead, additional ablation of a second circular band of tissues around the opening of the pulmonary veins will be given. This additional ablation is not standard procedure and is considered experimental. The Investigators are testing if adding more ablation sites will help maintain normal heart rhythm and reduce the rate of return to AF. The study will compare the occurrence of medical events and complications between the two groups. Identical supplies and equipment used in both techniques have been approved by Health Canada. Adenosine is currently approved by Health Canada for the treatment and diagnosis of arrhythmias. 396 participants from study sites across Canada will be randomly assigned "similar to flipping a coin" to treatment group 1 or group 2. After the ablation, participants will have study follow-up at 3, 6 and 12 months. All participant's will be followed for a minimum of 12 months.

Eligibility Criteria

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

At least one episode of AF documented on 12-lead ECG, Holter monitor or Loop recorder.

I am 18 years old or older.

I have AFib that doesn't respond to or can't take certain heart rhythm medicines.

+1 more

Exclusion Criteria

You have had a bad reaction to adenosine in the past.

Subjects that are pregnant

I cannot take blood thinners due to a bad reaction or other reasons.

+6 more

Participant Groups

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.

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