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Procedure
Ablation for Atrial Fibrillation (COAST-AF RCT Trial)
N/A
Recruiting
Led By Pablo Nery, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months and 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether adding atrial scar mapping to pulmonary vein isolation (PVI) is more effective than PVI alone in treating patients with persistent atrial fibrillation (AF).
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Catheter ablation may cause complications like bleeding at the catheter site, damage to blood vessels or the heart itself; arrhythmias; infection risks; and rarely more serious effects such as stroke.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 months and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months and 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of documented (>30s) AF, atrial flutter or atrial tachycardia occuring from day 91 to 18 months post ablation
Secondary study objectives
AF burden
Composite safety outcome
Incidence of any ECG documented AF with 90 days of ablation
+6 moreAwards & 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: 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Catheter ablation
2016
Completed Phase 4
~1260
Find a Location
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
195 Previous Clinical Trials
92,998 Total Patients Enrolled
24 Trials studying Atrial Fibrillation
6,544 Patients Enrolled for Atrial Fibrillation
Heart and Stroke Foundation of CanadaOTHER
130 Previous Clinical Trials
72,289 Total Patients Enrolled
7 Trials studying Atrial Fibrillation
5,237 Patients Enrolled for Atrial Fibrillation
Pablo Nery, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
2 Previous Clinical Trials
2,000 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
500 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.Treatable reasons for atrial fibrillation.You cannot take medication to prevent blood clots.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.You have a heart condition called hypertrophic cardiomyopathy.You have a serious problem with one of your heart valves.You have another health condition that is expected to significantly shorten your life.
Research Study Groups:
This trial has the following groups:- Group 1: Pulmonary Vein Isolation and scar ablation
- Group 2: Pulmonary Vein Isolation
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.
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