Testing PVI-PLUS ARM, INTERVENTIONAL ARM for atrial fibrillation
Official title: Randomized Controlled Trial- Ablation Strategy for Paroxysmal Atrial Fibrillation - Trigger and Substrate Guided Wide Area Radiofrequency Ablation Compared to Pulsed Field Ablation Pulmonary Vein Isolation
AWARE-2 - Randomized Controlled Trial Ablation Strategy for Paroxysmal Atrial Fibrillation - Trigger and Substrate Guided Wide Area Radiofrequency Ablation Compared to Pulsed Field Ablation Pulmonary Vein Isolation
Interventions
PVI-ONLY, CONTROL ARM
PULSED FIELD ABLATION (PFA) PVI-ONLY STRATEGY: CONTROL ARM
PVI-PLUS ARM, INTERVENTIONAL ARM
RADIOFREQUENCY CATHETER ABLATION (RFA) PVI-PLUS : INTERVENTION ARM
Canadian Sites (2)
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for32 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥18 years on the date of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → for the trial.
- +Subjects must have paroxysmal AF with at least one episode of AF over the past 12 months (patients on antiarrhythmic medications do not need to satisfy this criterion).
- +At least one episode of AF documented on 12-lead ECG, Holter monitor, Trans-telephonic monitor (TTM) or Loop Recorder.
- +Subjects must be able to provide informed consent.
Exclusion
- −Persistent and permanent AF.
- −History of previous catheter or surgical ablation for AF, AFl, AT, Atrioventricular Nodal Reentrant Tachycardia (AVNRT), Atrioventricular Reentrant Tachycardia (AVRT).
- −Documented AVNRT, AVRT, AT or Atrial Flutter prior to enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in the trial.
- −Previous pulmonary vein stenosis or pulmonary vein stent.
- −Pre-existing hemi-diaphragmatic paralysis.
- −Active intracardiac thrombus.
- −Contraindication to systemic oral anticoagulation therapy
- −Current immunosuppressant therapy (corticosteroids, biologic immunomodulators; such patients may be considered if they can safely discontinue immunosuppressants for three months prior to and for three months following catheter ablation).
- −Left ventricular ejection fraction \<35%.
- −NYHA Class 4 heart failure.
- −Hypertrophic cardiomyopathy
- −Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation).
- −Patients with mechanical mitral prosthetic valves
- −Known adverse reactionAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → to adenosine.
- −Chronic Kidney Disease ≥ Stage 4.
- −Significant congenital heart disease (including atrial septal defects or pulmonary vein abnormalities; however, subjects with patent foramen ovale will not be excluded).
- −Cerebral ischemic event (stroke or transient ischemic attack) in the six months prior to consenting for the trial.
- −History of thromboembolic events in the 6 months preceding enrollment.
- −Currently participating or anticipated to participate in interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical trials of drug, device or biologic agents that could affect the results of this trial.
- −Primary pulmonary hypertension
- −Rheumatic heart disease
- −Thrombocytosis, thrombocytopenia and other hypercoagulable states
- −Active systemic infection
- −Patients with life expectancy less than 12 months.
- −Unwilling or unable to comply fully with study procedures and follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
- −Pregnant subjects.
- −Previous left atrial (LA) ablation or LA surgery.
- −Reversible causes of AF (e.g., uncontrolled hyperthyroidism, within six months of cardiac surgery).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: PVI-ONLY, CONTROL ARMControl groupThe group a new treatment is measured against.Read more →, PVI-PLUS ARMArmOne of the groups in a study, each receiving something different.Read more →, INTERVENTIONALInterventional studyA study where participants are given something to see what happens.Read more → ARM.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 556 people.
The study is currently expected to finish around March 2030.
The main measurement is taken over: 61 to 730 days after ablation.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia — measured over 61 to 730 days after ablation.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04823299 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About PVI-ONLY, CONTROL ARMProcedure
PULSED FIELD ABLATION (PFA) PVI-ONLY STRATEGY: CONTROL ARM
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About PVI-PLUS ARM, INTERVENTIONAL ARMProcedure
RADIOFREQUENCY CATHETER ABLATION (RFA) PVI-PLUS : INTERVENTION ARM
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 61 to 730 days after ablation.
The study as a whole is currently expected to finish around 2030-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 556 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Ottawa, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Atrial fibrillation (AF) is a common heart rhythm disorder affecting over a million people in North America and is associated with serious complications including stroke, heart failure, reduced quality of life, and premature death. Catheter ablation has been shown to be more effective than medications for controlling symptoms and reducing the risk of these complications; however, recurrence of AF after ablation remains a significant challenge, often due to incomplete or ineffective initial procedures. This clinical trial aims to determine whether a novel, patient-tailored ablation strategy can improve outcomes compared to the current standard-of-care approach. Participants will be randomly assigned to undergo either standard pulmonary vein isolation or a more individualized ablation procedure that identifies and targets patient-specific sources of AF. All participants will undergo the ablation procedure, receive continuous heart rhythm monitoring, and be followed over time to assess recurrence and safety outcomes.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.