Ablation for Atrial Fibrillation
(COAST-AF RCT Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen byPablo Nery, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ottawa Heart Institute Research Corporation

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?A multicentre, parallel group, two arm, single-blinded randomized clinical trial, assessing the efficacy of a patient-tailored catheter ablation (CA) strategy guided by atrial scar mapping in addition to pulmonary vein isolation (PVI) when compared to PVI alone in patients with persistent atrial fibrillation (AF).

Eligibility Criteria

This trial is for adults over 18 with symptomatic persistent atrial fibrillation (AF) that's lasted beyond 3 months, as confirmed by ECG or other heart monitors. They must need a catheter ablation for AF and have a certain risk score (DR-FLASH >=4). People can't join if they've had previous ablations, have reversible AF causes, clotting in the heart, severe valve disease, are pregnant/breastfeeding, or can't take blood thinners.

Inclusion Criteria

You have ongoing symptoms from atrial fibrillation and need a catheter ablation procedure for it.

You have had a specific type of irregular heartbeat that lasted for more than 3 months, which was confirmed by different heart monitoring tests within the past 36 months.

Your DR-FLASH score is 4 or higher.

+2 more

Exclusion Criteria

You have had a procedure called catheter ablation for atrial fibrillation or left atrial flutter in the past.

You have had surgery to treat atrial fibrillation in the past.

You have a blood clot inside your heart.

+6 more

Participant Groups

The study tests whether adding atrial scar mapping to the usual pulmonary vein isolation (PVI) improves treatment outcomes in persistent AF patients. Participants will be randomly assigned to receive either just PVI or PVI plus tailored catheter ablation based on their specific heart scar patterns.

2Treatment groups

Experimental Treatment

Active Control

Group I: Pulmonary Vein Isolation and scar ablationExperimental Treatment1 Intervention

Wide area circumferential catheter ablation for pulmonary vein isolation and scar ablation

Group II: Pulmonary Vein IsolationActive Control1 Intervention

Wide area circumferential catheter ablation for pulmonary vein isolation

Catheter ablation is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Catheter ablation for: