Your session is about to expire
← Back to Search
Procedure
Catheter Ablation for Atrial Fibrillation (STARAF3 Trial)
N/A
Recruiting
Led By Atul Verma, Dr.
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients whose AF has been refractory to at least one antiarrhythmic drug
Patients undergoing first-time ablation procedure for AF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12-18 months
Awards & highlights
STARAF3 Trial Summary
This trial will compare the efficacy of three different ablation strategies for treating atrial fibrillation.
Who is the study for?
This trial is for adults over 18 with persistent atrial fibrillation (AF) lasting more than 3 months but less than three years, who have symptoms like palpitations or shortness of breath. They must have tried at least one antiarrhythmic drug without success and be willing to consent to the study. People can't join if they're pregnant, have paroxysmal AF, a low stroke risk score (CHA2DS2-VASc score of 0), an episode shorter than 3 months or longer than 3 years, or a very large left atrium.Check my eligibility
What is being tested?
The study compares three ablation techniques for treating persistent AF: isolating the pulmonary vein area alone (PVAI), PVAI plus targeting 'drivers' that may cause AF, and PVAI plus isolation of the heart's posterior wall. All methods use advanced catheter technology with cooling tips and sensors.See study design
What are the potential side effects?
Ablation procedures might lead to complications such as bleeding or bruising at the catheter insertion site, damage to blood vessels or heart tissue, arrhythmias during recovery, pericarditis (inflammation around the heart), and rarely more serious risks like stroke.
STARAF3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My atrial fibrillation didn't improve with at least one medication.
Select...
I am having my first ablation procedure for atrial fibrillation.
STARAF3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-12-18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12-18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM).
Secondary outcome measures
Change in AF burden post-ablation procedure (% of time in AF)
Correlation of acute AF termination on long-term procedural outcome
Each of the above success measures stratified by CHA2DS2-VASc score
+17 moreSTARAF3 Trial Design
3Treatment groups
Active Control
Group I: PV antral isolation plus ablation of driversActive Control1 Intervention
PV antral isolation plus ablation of drivers (PVAI+drivers)
Group II: PV antral isolation plus isolation of posterior wallActive Control1 Intervention
PV antral isolation plus isolation of LA posterior wall (PVAI+Box)
Group III: PV antral isolation alone (PVAI)Active Control1 Intervention
PV antral isolation alone (PVAI)
Find a Location
Who is running the clinical trial?
Montreal Heart InstituteOTHER
120 Previous Clinical Trials
68,204 Total Patients Enrolled
8 Trials studying Atrial Fibrillation
5,196 Patients Enrolled for Atrial Fibrillation
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
446 Previous Clinical Trials
159,111 Total Patients Enrolled
Atul Verma, Dr.Principal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
2 Previous Clinical Trials
696 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
696 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My AFib episodes don't last more than 7 days.My atrial fibrillation didn't improve with at least one medication.I am having my first ablation procedure for atrial fibrillation.Your left atrial diameter is larger than 60 mm when seen from a certain position.I have felt symptoms of AF, like palpitations or shortness of breath, in the last 5 years.I have had atrial fibrillation episodes lasting more than 3 years.I have had atrial fibrillation continuously for more than 3 months but less than 3 years.Doctors will not try to correct my irregular heartbeat.You must have been diagnosed with atrial fibrillation (AF) using specific heart monitoring tests within the last 2 years.My heart has been irregularly beating for less than 3 months.I am 18 years old or older.My atrial fibrillation is due to a treatable cause.I cannot take blood thinners or heparin due to health reasons.Your CHA2DS2-VASc score is 0.
Research Study Groups:
This trial has the following groups:- Group 1: PV antral isolation plus ablation of drivers
- Group 2: PV antral isolation plus isolation of posterior wall
- Group 3: PV antral isolation alone (PVAI)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are more participants currently being enrolled in this research project?
"Affirmative. Concerning this clinical trial, the information on clinicialtrials.gov states that it is actively recruiting patients; first posted on June 1st 2021 and recently updated on June 13th 2022. A total of 600 participants are required from a single medical facility."
Answered by AI
How many individuals are participating in this experiment?
"Affirmative. According to the information accessed from clinicaltrials.gov, this study is actively recruiting participants with 600 individuals being sought after at a single site since its initial post on June 1st 2021 and last edit taking place June 13th 2022."
Answered by AI
Recent research and studies
Popular Categories
Share this study with friends
Copy Link
Messenger