Personalized Catheter Ablation for Atrial Fibrillation
(AWARE-2 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

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 a heart rhythm disturbance that affects over a million people in North America. AF can cause strokes, heart failure, poor quality of life and may lead to premature death. Catheter ablation has been shown to be superior to medications for symptoms, prevention of stroke and heart failure. AF recurrence is a problem after catheter ablation. Our research has found that in most cases AF recurrence occurs because the catheter procedure was ineffective. The objective of our clinical trial is to find out if a new method of performing the catheter procedure will be more effective in preventing AF recurrence compared to the current standard of care ablation procedure. Subjects will be randomly allocated to undergo either the standard of care ablation, or the novel patient tailored ablation. The novel method aims to understand the unique factors responsible for AF in each individual and uses this information to perform a patient-tailored catheter ablation procedure. This is expected to improve the results of AF ablation. The effectiveness and safety of the ablation procedure will be specifically evaluated in women to understand the effect of sex on AF ablation.

Eligibility Criteria

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.

Inclusion Criteria

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.

Subjects must be able to provide informed consent

+1 more

Exclusion 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.

+19 more

Participant Groups

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.

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)