RF Ablation for Atrial Fibrillation

Recruiting at 11 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)

325 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

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 data supports the effectiveness of the treatment EPi-Sense Guided Coagulation System for atrial fibrillation?

The Convergent Procedure, which involves epicardial and endocardial ablation, has shown a success rate of 80% in treating persistent atrial fibrillation, suggesting that similar epicardial ablation techniques like the EPi-Sense Guided Coagulation System may also be effective. ^{1 2 3 4 5}

Is RF Ablation for Atrial Fibrillation generally safe for humans?

The research articles provided do not contain specific safety data for RF Ablation for Atrial Fibrillation or the related devices mentioned. ^{1 3 4 6 7}

How is the EPi-Sense Guided Coagulation System treatment for atrial fibrillation different from other treatments?

The EPi-Sense Guided Coagulation System is unique because it involves a minimally invasive surgical procedure that uses a suction support adapter to ensure effective contact between the ablation probe and the heart tissue, aiming for thorough coagulation. This approach is different from standard catheter-based ablation techniques and can be used as a stand-alone procedure or in combination with other cardiac surgeries. ^{3 4 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Epicardial electrical isolation of the right atrial appendage on the beating heart with an infrared coagulator. [2016]

2. England pubmed.ncbi.nlm.nih.gov

A biophysical model of atrial fibrillation ablation: what can a surgeon learn from a computer model? [2008]

3. United States pubmed.ncbi.nlm.nih.gov

A new instrument of suction support adapter system for epicardial radiofrequency ablation. [2010]

4. England pubmed.ncbi.nlm.nih.gov

Epicardial box lesion using bipolar biparietal radiofrequency and multimodality scar evaluation-a case series. [2022]

5. England 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. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Analysis of catheter contact force during atrial fibrillation ablation using the robotic navigation system: results from a randomized study. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Simultaneous assessment of contact pressure and local electrical coupling index using robotic navigation. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

[Surgical atrial fibrillation ablation therapy and postoperative monitoring]. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Atricure bipolar radiofrequency clamp for intraoperative ablation of atrial fibrillation. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Impact of respiration gating on image integration guided atrial fibrillation ablation. [2021]