RF Ablation for Atrial Fibrillation

Not currently recruiting at 22 trial locations

Overseen By Caroline Mazzola

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AtriCure, Inc.

Must be taking: Class I/III AAD

Must not be taking: Anticoagulants, Ventricular arrhythmias

Disqualifiers: Previous cardiac surgery, Renal dysfunction, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 1 day (procedure)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the EPi-Sense Coagulation System, a surgical cardiac ablation device, for individuals with long-term atrial fibrillation (AF) that causes symptoms such as palpitations or shortness of breath. It targets those who have not found success with at least one type of anti-arrhythmic drug. The treatment uses the EPi-Sense system to make small modifications to heart tissue to help control irregular heartbeats. Individuals who have experienced AF for over a year and continue to have symptoms might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for managing persistent AF symptoms.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should be refractory or intolerant to at least one antiarrhythmic drug (AAD), which might imply changes to your current medication regimen.

What prior data suggests that the EPi-Sense Guided Coagulation System is safe for treating atrial fibrillation?

Research has shown that the EPi-Sense Guided Coagulation System is safe for patients with long-standing persistent atrial fibrillation (AF), a type of irregular heartbeat. One study found this system both safe and effective for patients who have been difficult to treat in the past. However, like any medical procedure, side effects can occur. Some reported issues include fluid around the lungs in about 7.6% of cases, along with a few instances of sudden kidney problems and new heart failure. Despite these, the FDA has approved the device, indicating thorough safety checks. Prospective trial participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for atrial fibrillation, which often involve traditional catheter ablation or medications, the EPi-Sense Guided Coagulation System offers a unique hybrid approach. This treatment combines both epicardial and endocardial techniques to create lesions that isolate the pulmonary veins, critical for preventing abnormal heart rhythms. What sets it apart is the minimally invasive access through trans-diaphragmatic or sub-xyphoid methods, avoiding chest incisions. Researchers are excited about this technique because it aims to improve precision and outcomes while reducing recovery time and potential complications associated with more invasive procedures.

What evidence suggests that the EPi-Sense Guided Coagulation System is effective for treating atrial fibrillation?

Research has shown that the EPi-Sense Guided Coagulation System, which participants in this trial will receive, effectively treats long-lasting atrial fibrillation (AF), a type of irregular heartbeat. In one study, about 75% of patients using this system were free from AF symptoms after one year. Another study found that this treatment significantly reduced AF episodes and helped maintain stable heart rhythms. The system employs a technique called hybrid ablation, targeting the heart tissue causing the irregular beats. The FDA has approved this method, deeming it safe and effective for managing AF. Overall, evidence suggests it can benefit those dealing with persistent AF. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-79 with symptomatic long-standing persistent atrial fibrillation, who haven't responded to certain antiarrhythmic drugs. Participants must have a life expectancy over a year and a left atrium size ≤ 6.0 cm. Exclusions include pregnancy, severe heart failure, treatment for ventricular arrhythmias, recent participation in other trials, cognitive impairment affecting consent ability, and various medical conditions that could interfere with the study or are risks due to the procedure.

Inclusion Criteria

Life expectancy > 12 months

Provides written informed consent

Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography [TTE] with parasternal 4 chamber view or equivalent imaging modality

Exclusion Criteria

I have Barrett's esophagus.

Pregnant or planning to become pregnant during study

Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Hybrid Convergent procedure using the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation.

1 day (procedure)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including evaluation of freedom from AF/AT/AFL and incidence of adverse events.

12 months

Multiple visits (in-person and virtual) over 12 months

Long-term Follow-up

Participants' long-term outcomes are assessed, including quality of life and freedom from AF/AT/AFL over 3 years.

3 years

What Are the Treatments Tested in This Trial?

Interventions

• EPi-Sense Guided Coagulation System

Trial Overview The CONVERGE PAS study tests the EPi-Sense® Guided Coagulation System's effectiveness and safety when used commercially on patients with long-standing persistent AF who don't respond well to standard treatments. It involves epicardial and endocardial radiofrequency ablation—a technique using heat energy to destroy problematic heart tissue causing irregular rhythms.

How Is the Trial Designed?

Group I: Hybrid Convergent Experimental Treatment 1 Intervention

Once the procedure intra-op exclusion conditions have been evaluated, the Epicardial linear lesions will be created endoscopically using the EPi-Sense®-Guided Coagulation System or EPi-Sense ST™ Coagulation System throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. An endocardial ablation catheter will be used to complete the isolation of the pulmonary veins and create a cavotricuspid lesion to prevent typical atrial flutter. Posterior and other linear lesions such as a roof lesion and mitral valve isthmus lesion will not be created during the endocardial component of the convergent procedure. Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi-Sense®- Guided Coagulation System or EPi-Sense ST™ Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation.

EPi-Sense Guided Coagulation System is already approved in United States for the following indications:

Approved in United States as EPi-Sense Guided Coagulation System for:

• Symptomatic long-standing persistent atrial fibrillation in patients who are refractory or intolerant to at least one Class I and/or III antiarrhythmic drug (AAD)

Who Is Running the Clinical Trial?

AtriCure, Inc.

Lead Sponsor

Trials

43

Recruited

22,800+

Published Research Related to This Trial

In a study of 15 patients undergoing atrial fibrillation ablation, successful pulmonary vein isolation was linked to a significant decrease in the electrical coupling index (ECI), indicating effective tissue contact during the procedure.

The ECI values dropped by an average of 32.2% during radiofrequency delivery and 25.4% immediately after, suggesting that monitoring ECI can serve as a reliable marker for assessing lesion efficacy in AF ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous assessment of contact pressure and local electrical coupling index using robotic navigation. Dello Russo, A., Fassini, G., Casella, M., et al.[2021]

The Convergent Procedure, which combines epicardial and endocardial ablation techniques, has demonstrated an 80% success rate in treating persistent and longstanding persistent atrial fibrillation (AF) in approximately 100 patients over 2 years, indicating its efficacy as a treatment option.

This procedure is particularly beneficial for patients with underlying structural heart disease, as it addresses the complexities of their condition and should be considered a first-line treatment for those with limited options for managing their AF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Convergent Procedure - A Standardised and Anatomic Approach Addresses the Clinical and Economic Unmet Needs of the Persistent Atrial Fibrillation Population. McKinnie, J.[2020]

In a study of 80 patients with atrial fibrillation, the use of the Sensei X™ robotic navigation system during pulmonary vein isolation procedures resulted in significantly higher contact force on the pulmonary veins compared to procedures without the system.

Patients who underwent ablation with the Sensei X™ RNS experienced a higher rate of freedom from AF recurrence after one year (90% vs. 65%) and reduced fluoroscopy time, indicating both efficacy and safety benefits of using the robotic system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of catheter contact force during atrial fibrillation ablation using the robotic navigation system: results from a randomized study. Dello Russo, A., Fassini, G., Conti, S., et al.[2018]

The Medtronic Cardioblate Gemini-S Irrigated RF Surgical Ablation System effectively creates permanent transmural scars in patients with therapy-refractory persistent atrial fibrillation, as confirmed by acute endocardial validation and multimodal imaging.

In a small study of three patients, two experienced recurrence of atrial arrhythmias after two years, but the ablation scars remained intact, indicating that the mechanism of recurrence was not related to the areas targeted by the ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epicardial box lesion using bipolar biparietal radiofrequency and multimodality scar evaluation-a case series. Bijvoet, GP., Chaldoupi, SM., Bidar, E., et al.[2022]

Surgical ablation therapy for atrial fibrillation is recommended for both symptomatic and asymptomatic patients at low risk, especially after catheter ablation has failed, highlighting its role as a viable treatment option.

Minimally invasive surgical techniques combined with interdisciplinary collaboration between cardiologists and surgeons can lead to high success rates in treating atrial fibrillation, while implantable loop recorders provide continuous heart rhythm monitoring for better patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical atrial fibrillation ablation therapy and postoperative monitoring]. Hanke, T., Sievers, HH.[2021]

The suction support adapter significantly improved the effectiveness of epicardial ablation on a beating heart, achieving deeper and narrower coagulation compared to using the ablation probe alone, as demonstrated in a study with 12 pigs.

All cases using the adapter resulted in successful electrical isolation of the atrial wall, while only one case without the adapter achieved this, indicating that the device enhances the safety and reliability of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new instrument of suction support adapter system for epicardial radiofrequency ablation. Kadoya, S., Watanabe, G., Koshida, Y., et al.[2010]

The Atricure bipolar radiofrequency system was evaluated in 120 patients for the intraoperative treatment of atrial fibrillation (AF), demonstrating no device-related complications, which highlights its safety in clinical use.

The system effectively creates transmural lesions for pulmonary vein isolation, although careful application is crucial to avoid incomplete isolation due to tissue folding, which can be resolved with reapplication of the clamp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atricure bipolar radiofrequency clamp for intraoperative ablation of atrial fibrillation. Gillinov, AM., McCarthy, PM.[2019]

A systematic study using a biophysical model of human atria found that certain ablation line patterns for treating atrial fibrillation can achieve high success rates, with up to 90-100% conversion rates when combining lines from both the right and left atria.

The study identified that a single closed line for pulmonary vein isolation yielded a 55% success rate, while the inclusion of a left isthmus line was crucial in preventing uncommon left atrial flutter, suggesting that fewer lines can still be effective compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A biophysical model of atrial fibrillation ablation: what can a surgeon learn from a computer model? Ruchat, P., Virag, N., Dang, L., et al.[2008]

The use of an infrared coagulator on the beating heart during a coronary artery bypass graft procedure successfully restored sinus rhythm in a patient with atrial fibrillation.

Postoperative electrophysiologic studies confirmed that the infrared coagulator created a bidirectional block in the right atrial appendage, suggesting its potential to enhance the epicardial Maze procedure for treating atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epicardial electrical isolation of the right atrial appendage on the beating heart with an infrared coagulator. Kubota, H., Sudo, K., Takamoto, S., et al.[2016]

In a study of 140 patients undergoing catheter ablation for atrial fibrillation, the use of a respiratory gating module significantly reduced total procedure times and fluoroscopy times, enhancing the efficiency of the procedure.

The respiratory gating also led to shorter ablation times without increasing the duration of RF applications or mapping times, suggesting it improves the overall effectiveness of the ablation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of respiration gating on image integration guided atrial fibrillation ablation. Özcan, EE., Szeplaki, G., Tahin, T., et al.[2021]

Citations

1. atricure.com atricure.com/healthcare-professionals/therapies/hybrid-af-therapy/clinical-data

Hybrid AF Therapy Clinical Data | CONVERGE Trial Results This prospective, single site, observational post-market study evaluated atrial fibrillation (AF)-free survival at 12 months and at 3 years among long-standing ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01984346?term=AREA%5BNCTIdSearch%5D(NCT01984346)&rank=1

Epi/Endo Ablation For Treatment of Persistent Atrial ... The objective of this randomized pivotal study is to evaluate the safety and efficacy of the AtriCure EPi-Sense®-AF Guided Coagulation System with VisiTrax® for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9463711/

Hybrid Convergent ablation for atrial fibrillation Given emerging evidence on the safety and effectiveness of Hybrid Convergent ablation and recent FDA approval of the EPi-Sense Guided Coagulation System ( ...

4. atricure.com atricure.com/sites/default/files/pdf-doc/PM-US-0053D-0625-G_EPi-Sense_One-Pager.pdf

Hybrid AF™ Therapy EPi-Sense® Ablation Device EPi-Sense RF Technology combined with Hybrid AF Therapy, is the only ablation system proven safe and effective for the treatment of long-standing persistent ...

5. annalscts.com annalscts.com/article/view/17078/html

Hybrid strategies for stand-alone surgical ablation of atrial ... This narrative review aims to discuss the rationale behind the concept of hybrid ablation for the treatment of AF regarding different available strategies.

6. wiley.authorea.com wiley.authorea.com/users/435260/articles/538410/download_latex

Adverse events related to Atricure EPi-Sense Coagulation ... Pleural effusion was reported in 6 (7.6%) device related AE. 2 events (2.5%) each of acute renal failure, new onset heart failure, atrial fibrillation with ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666501822001118

Hybrid Convergent ablation for atrial fibrillation Given emerging evidence on the safety and effectiveness of Hybrid Convergent ablation and recent FDA approval of the EPi-Sense Guided Coagulation System ( ...

8. fda.gov fda.gov/medical-devices/recently-approved-devices/epi-senser-guided-coagulation-system-p200002

EPi-Sense® Guided Coagulation System – P200002 In a clinical study, doctors treated 38 people with long-standing persistent atrial fibrillation using this device. The heart rhythm was ...