Ablation and LAA Exclusion Systems for Atrial Fibrillation

Recruiting at 4 trial locations

Overseen By BoxX-NoAF Trial Inbox

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: AtriCure, Inc.

Disqualifiers: Atrial fibrillation, Pacemaker, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate (during surgery)

960 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding two treatments during heart surgery can reduce the risk of developing atrial fibrillation (AF), a common heart rhythm issue, post-surgery. The first treatment, the Isolator® Synergy™ EnCompass® Ablation System, uses energy to create small scars in the heart to prevent abnormal rhythms. The second treatment, the AtriClip® LAA Exclusion System, blocks a small heart area where blood clots can form. Individuals aged 65 or older, scheduled for heart surgery, and without a history of AF may be suitable candidates for this trial. As an unphased trial, this study allows patients to contribute to innovative research that could enhance heart surgery outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System are safe for use in cardiac surgery?

Research has shown that the Isolator Synergy EnCompass Ablation System and AtriClip LAA Exclusion System are designed to improve heart surgery outcomes by reducing irregular heartbeats post-surgery. Surgeons use these tools to safely create specific patterns on heart tissue, potentially leading to fewer complications.

The AtriClip is already employed to close off the left atrial appendage, a small sac in the heart, which helps lower stroke risk. Using it under direct vision enhances the procedure's safety and effectiveness. Although specific safety data for this trial is unavailable, the devices' existing use for similar purposes suggests they are safe.

Overall, these treatments have been well-tolerated in other applications, making them promising options for reducing post-surgery complications without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Isolator® Synergy™ EnCompass® Ablation System and the AtriClip® LAA Exclusion System because they offer a comprehensive approach to treating atrial fibrillation during cardiac surgery. Unlike standard treatments that focus on medication or standalone procedures, this combination targets both the rhythm disorder with ablation and reduces the risk of stroke by excluding the left atrial appendage. This dual strategy could enhance patient outcomes by tackling two major issues associated with atrial fibrillation in one go, potentially leading to more effective long-term management of the condition.

What evidence suggests that the Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System are effective for reducing post operative atrial fibrillation?

Research has shown that the Isolator Synergy EnCompass Ablation System and AtriClip LAA Exclusion System can help reduce atrial fibrillation (AF) after heart surgery. In this trial, participants in the treatment arm will undergo index cardiac surgery along with Ablation and Left Atrial Appendage Exclusion using the AtriClip. The EnCompass clamp creates a "Box lesion," a specific area that blocks the faulty electrical signals causing AF. The AtriClip closes off the left atrial appendage, a small pouch in the heart linked to AF. Together, these tools aim to lower the chance of AF occurring after surgery. Studies have shown that these methods may improve patient outcomes by reducing the risk of AF and related complications. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

The BoxX-NoAF trial is for patients at risk of developing Atrial Fibrillation (AF) who haven't yet had it but are undergoing routine cardiac surgery. It aims to see if adding two procedures can prevent post-operative AF and reduce long-term AF incidence.

Inclusion Criteria

I am scheduled for heart surgery that involves bypass and opening the outer layer of my heart.

I am 65 or older with a high stroke risk score.

Exclusion Criteria

I have had a procedure to close or remove my left atrial appendage.

I have severe heart failure symptoms.

I have had atrial fibrillation or flutter before heart surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo index cardiac surgery with or without ablation and Left Atrial Appendage Exclusion

Immediate (during surgery)

Post-operative Monitoring

Participants are monitored for the occurrence of post operative atrial fibrillation and other safety endpoints

30 days

Follow-up

Participants are monitored for the occurrence of clinical atrial fibrillation

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System

Trial Overview This study tests whether the Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System can lower the chances of getting AF after other heart surgeries. Patients are randomly chosen to receive these additional treatments or not.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Index cardiac surgery + Ablation + Left Atrial Appendage Exclusion with AtriClip

Group II: Control Active Control 1 Intervention

Index cardiac surgery only

Who Is Running the Clinical Trial?

AtriCure, Inc.

Lead Sponsor

Trials

43

Recruited

22,800+

Citations

1. ir.atricure.com ir.atricure.com/news-releases/news-release-details/atricure-announces-first-patient-treated-boxx-noaf-clinical

AtriCure Announces the First Patient Treated in the BoxX- ... Trial will evaluate the safety and effectiveness of the AtriCure Isolator® Synergy™ EnCompass® clamp and AtriClip® Left Atrial Appendage ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10998969/

Isolator Synergy EnCompass clamp: surgical notes - PMC The EnCompass clamp was uniquely crafted to produce the “Box lesion” with just one application. Utilizing this device could simplify Box lesion creation.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06989775

Study Details | NCT06989775 | BoxX-NoAF Clinical Trial Patients with POAF tend to have worse acute and long-term clinical outcomes. BoxX-NoAF is a randomized trial to evaluate if prophylactic ...

4. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=388461

ANZCTR - Registration The AtriCure Isolator Synergy EnCompass-S Ablation System will be used in one planned surgical procedure per patient, the number intra-procedural of energy ...

5. atricure.com atricure.com/patients-caregivers/clinical-evidence/trials-results

Trials with Results | Atrial Fibrillation Treatment This page contains information about clinical trials that are sponsored by AtriCure, Inc. If you wish to learn more, please visit ClinicalTrials.gov.

6. medicaleconomics.com medicaleconomics.com/view/atricure-launches-first-of-its-kind-clinical-trial-to-prevent-post-operative-atrial-fibrillation

AtriCure launches first-of-its-kind clinical trial to prevent ... The trial will assess the safety and effectiveness of the AtriCure Isolator Synergy EnCompass clamp and AtriClip Left Atrial Appendage Exclusion ...

7. atricure.com atricure.com/healthcare-professionals/therapies/LAAM/atriclip-exclusion-system/atriclip-pro-v-device

AtriClip PRO-V Device | LAA Exclusion System The AtriClip LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization.