Testing Isolator® Synergy™ EnCompass® Ablation for post operative atrial fibrillation
Official title: BoxX-NoAF Clinical Trial
EnCompass Clamp and the AtriClip in Box Lesion and Left Atrial Appendage EXclusion Procedure for the Prevention of New Onset of Atrial Fibrillation
- 2 groups
- Sites in New Westminster, Hamilton and 2 more cities
- Recruiting
Interventions
- Medical device
Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System
Box lesion ablation with the Isolator Synergy EnCompass Clamp System and LAAE using the AtriClip LAA Exclusion System at the time of planned cardiac surgery
Canadian Sites (4)
4 of 4 recruiting
- Recruiting
Royal Columbian Hospital
New Westminster, British Columbia
- Recruiting
Hamilton General Hospital
Hamilton, Ontario
- Recruiting
London Health Sciences Centre, University Hospital
London, Ontario
- Recruiting
Montreal Heart Institute
Montreal, Quebec
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 65 years and CHA2DS2-VASc ≥ 3
- +Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium
Exclusion
- −Known allergy to Nitinol or nickel sensitivity
- −Prior procedure involving opening the pericardium or entering the pericardial space
- −Prior LAA occlusion, exclusionExclusion criteriaThe things that would prevent someone from taking part.Read more →, or removal (surgical or percutaneous)
- −Presence of a permanent pacemaker
- −Infiltrative cardiomyopathies (i.e. amyloidosis)
- −Planned cardiac surgical procedure using non-sternotomy approaches
- −Patients whose planned procedure is a heart transplant or implantation of any long-term ventricular assist devices
- −Presence of ventricular arrhythmia
- −Active endocarditis
- −NYHA Class IV heart failure symptoms
- −Preoperative need for an intra-aortic ballon pump or intravenous inotropes
- −Known medical condition with expected survival of less than 1 year
- −Other comorbidities that in the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion make the subject unsuitable candidate to complete the protocolProtocolThe detailed plan a study must follow.Read more → required intervention or visits
- −Current enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial
- −Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
- −Known severe symptomatic carotid disease
- −Documented history of atrial fibrillation or atrial flutter anytime prior to the cardiac surgery
- −Patients undergoing off-pump surgery
- −Active systemic infection at the time of cardiac surgery requiring antibiotics
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 way to prevent a condition from developing.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA ExclusionExclusion criteriaThe things that would prevent someone from taking part.Read more → System.
Registry label: A: Treatment
Group B receives no study treatment and is followed for comparison.
Registry label: B: Control
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
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.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
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 no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 65 years, with no upper limit given.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
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 960 people.
The study is currently expected to finish around December 2029.
The main measurement is taken over: 30 days post index cardiac surgical procedure.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Primary Effectiveness EndpointEndpointThe specific thing a study measures to answer its question.Read more → — measured over 30 days post index cardiac surgical procedure.
Primary Safety Endpoint — measured over 30 days post index cardiac surgical procedure.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06989775 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 Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion SystemDevice
Box lesion ablation with the Isolator Synergy EnCompass Clamp System and LAAE using the AtriClip LAA Exclusion System at the time of planned cardiac surgery
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment 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 65 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 no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
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 65 years, with no upper limit given.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
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: 30 days post index cardiac surgical procedure.
The study as a whole is currently expected to finish around 2029-12.
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 960 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 10 locations, including: New Westminster, British Columbia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada; Montreal, Quebec, Canada; Ann Arbor, Michigan, United States; Grand Rapids, Michigan, United States, and 4 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Post Operative Atrial Fibrillation (POAF) is the most common complication of cardiac surgery. POAF incidence can exceed 50% depending on the patient baseline characteristics and surgery type. Patients with POAF tend to have worse acute and long-term clinical outcomes. BoxX-NoAF is a randomized trial to evaluate if prophylactic ablation and exclusion of the Left Atrial Appendage at the time of other routine cardiac surgery can reduce the incidence of post operative AF and clinical AF during long term follow up in patients who have not yet developed AF but are at risk.
Other Sites (6)
University of Michigan
Ann Arbor, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Trinity Health
Ypsilanti, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Northwell Health
Manhasset, New York, United States
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States
If this study interests you
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This 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.