AtriCure Devices for Atrial Fibrillation

(TRAC-AF Trial)

Recruiting at 31 trial locations

Overseen By Joey Stimler, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AtriCure, Inc.

Disqualifiers: Concurrent trial, Local governance

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

10000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of certain AtriCure devices for individuals undergoing heart procedures to treat atrial fibrillation (AF), a condition characterized by irregular heartbeats. The goal is to collect real-world data on the safety and effectiveness of these devices during cardiac ablation, which targets and destroys small areas of heart tissue causing the irregular beats. Individuals scheduled for or who have undergone cardiac ablation with an AtriCure device qualify, but the trial also includes those treated with other therapies for comparison. Participants must provide informed consent to join the study. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants the opportunity to contribute to the validation of a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

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 these AtriCure devices are safe for cardiac ablation?

Research has shown that ablation treatments, such as cryoballoon and radiofrequency ablation, have generally been safe in past studies. One study found both methods had low complication rates during the procedure. Specifically, cryoballoon ablation presented a 50% lower risk of requiring a procedure to remove fluid around the heart compared to radiofrequency ablation.

Additionally, a large analysis found serious side effects were rare for both methods, with the risk of major problems being less than 1% for each type of ablation. This suggests that most patients tolerate these treatments well.

Overall, the evidence indicates that ablation treatments are relatively safe options for managing certain heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ablation as a treatment for atrial fibrillation (AF) because it directly targets the heart tissue responsible for irregular heartbeats. Unlike standard treatments such as medication or electrical cardioversion that aim to control symptoms, ablation offers a more permanent solution by destroying the small area of the heart causing the arrhythmia. This approach can lead to a significant reduction in symptoms and potentially eliminate the need for ongoing medication. By focusing on the root cause rather than just managing symptoms, ablation represents a promising advancement in AF treatment.

What evidence suggests that AtriCure devices are effective for cardiac ablation?

Research has shown that ablation effectively treats atrial fibrillation (AF), a condition where the heart sometimes beats irregularly. After the final ablation procedure, the likelihood of treatment failure is low—about 1.76% per year for those with paroxysmal AF, where the irregular heartbeat comes and goes. One study found that 92% of patients remained free from AF five years after their ablation. Another study reported that 64% of patients with paroxysmal AF were free from irregular heartbeats three years after treatment. Overall, ablation provides good long-term results for many people with AF. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

I am scheduled for or have had a cardiac ablation.

I am willing to sign the consent form.

I am 18 years old or older and can legally consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ablation procedures using AtriCure devices

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Long-term monitoring

Collect patient data on Atrial Fibrillation burden after the ablation procedure

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Ablation

Ablation is already approved in European Union, United States, Canada, Japan, China for the following indications:

Approved in European Union as Ablation Therapy for:

• Atrial Fibrillation
• Ventricular Tachycardia
• Other cardiac arrhythmias

Approved in United States as Ablation Therapy for:

• Atrial Fibrillation
• Ventricular Tachycardia
• Other cardiac arrhythmias
• Cancer treatment (e.g., liver, lung, kidney)

Approved in Canada as Ablation Therapy for:

• Atrial Fibrillation
• Ventricular Tachycardia
• Other cardiac arrhythmias

Approved in Japan as Ablation Therapy for:

• Atrial Fibrillation
• Ventricular Tachycardia

Approved in China as Ablation Therapy for:

• Atrial Fibrillation
• Ventricular Tachycardia

Who Is Running the Clinical Trial?

AtriCure, Inc.

Lead Sponsor

Trials

43

Recruited

22,800+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5901816/

Radiofrequency Ablation versus Cryoablation in the Treatment ...

Our meta-analysis suggests that cryoballoon ablation provides comparable benefits with regard to freedom from atrial fibrillation at medium-term follow-up.

2.

eurjmedres.biomedcentral.com

eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02911-x

Cryoballoon versus radiofrequency ablation for persistent ...

This study aimed to systematically evaluate the efficacy and safety of cryoballoon (CB) and radiofrequency (RF) ablation in the treatment of persistent AF.

3.

heartrhythmjournal.com

heartrhythmjournal.com/article/S1547-5271(23)00128-5/fulltext

Very long term outcomes of atrial fibrillation ablation

After final ablation, for years 2 to 15, the failure rate was 1.76%/yr for PAF, 2.04%/yr for PeAF, and 2.60%/yr for LsAF. There are 371 patients ...

4.

nature.com

nature.com/articles/s41598-025-90920-5

Long-term outcomes of cryoballoon versus robotic ...

Overall, 92% of patients (184/200) completed their follow-up at 5 years after a single AF ablation procedure, including 93 patients in the RMN ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405500X18308892

Long-Term Outcomes After Ablation for Paroxysmal Atrial ...

PVI using the CB2 was an effective treatment for patients with pAF, with freedom from all atrial arrhythmias of 64% at 36 months.

6.

heartrhythmjournal.com

heartrhythmjournal.com/article/S1547-5271(25)00193-6/fulltext

In-hospital safety of cryoballoon and radiofrequency ...

RF and CB ablation had low overall procedural complication rates, with CB ablation showing a 50% reduced risk of pericardiocentesis. Centers ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40401921/

A Meta-Analysis of Randomized Controlled Trials

This meta-analysis aims to compare the efficacy and safety outcomes of cryoballoon ablation (CBA) and radiofrequency ablation (RFA) in patients with persistent ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1547527124023725

Pulsed-field vs cryoballoon vs radiofrequency ablation ...

The purpose of this study was to compare the procedural and long-term outcomes in patients with persistent AF undergoing PVI using PFA, CBA, or RFA.

9.

academic.oup.com

academic.oup.com/europace/article/27/8/euaf157/8243885

Pulsed field ablation compared to thermal ablation techniques ...

Methods ; In-hospital outcomes. Serious adverse events ; Serious adverse events, 210 (0.7%), 343 (1.1%) ; In-hospital mortality, 20 (0.1%), 22 (0.1 ...