FARAPULSE Ablation for Atrial Fibrillation

(ADVANTAGE AF Trial)

Recruiting at 57 trial locations

Overseen By Thomas Stoltz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must be taking: Anticoagulants

Must not be taking: Phosphodiesterase inhibitors

Disqualifiers: Heart failure, Hypertension, Diabetes, Obesity, others

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

Compensation: Varies

Number of Visits: 26

669 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a device that uses electrical pulses to treat patients with persistent atrial fibrillation who do not respond to drugs. The device works by creating small scars in the heart to block abnormal electrical signals and restore normal rhythm.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must have been on anticoagulation therapy for at least 4 weeks before the procedure, and you cannot use phosphodiesterase inhibitors within 24 hours of the ablation procedure.

What data supports the effectiveness of the FARAPULSE Ablation System treatment for atrial fibrillation?

Ablation treatments for atrial fibrillation (AF) have shown success in reducing AF burden, which means less time spent in AF, leading to improved quality of life. Success rates for ablation in paroxysmal AF are reported at 60-70% after a single procedure and up to 80% after multiple procedures, indicating that ablation is more effective than drug-based treatments. ^{1 2 3 4 5}

Is the FARAPULSE Ablation System safe for humans?

The safety of catheter ablation for atrial fibrillation, including systems like FARAPULSE, has been studied, showing that while it is generally safe, there are potential complications. Safety profiles have improved over time with advancements in technology and experience. ^{6 7 8 9 10}

How is the FARAPULSE Ablation System treatment different from other atrial fibrillation treatments?

The FARAPULSE Ablation System is unique because it uses a non-thermal method to treat atrial fibrillation, unlike traditional treatments that often use heat-based techniques like radiofrequency or cryoablation. This novel approach may reduce the risk of damage to surrounding tissues during the procedure. ^{11 12 13 14 15}

Research Team

Vivek Reddy, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

This trial is for adults with symptomatic, drug-resistant persistent atrial fibrillation (AF) that's been continuous for more than 7 days but less than a year. Participants must have tried at least one antiarrhythmic drug without success and be able to attend all study-related tests. Exclusions include secondary AF due to reversible causes, severe heart conditions, certain pre-existing medical devices or implants, recent stroke or bleeding events, pregnancy, uncontrolled health issues like diabetes or sleep apnea, and those currently in other conflicting studies.

Inclusion Criteria

I have persistent AF that's resistant to at least one heart rhythm medication.

I am at least 18 years old or meet the age requirement by local law.

I am willing and able to give my consent for treatment.

Exclusion Criteria

If you have a LUX-Dx device that was put in more than 6 months ago and is expected to last less than 1 year, you cannot participate.

I cannot have a device implanted under my skin for health reasons.

I have severe lung disease or need extra oxygen.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pulsed Field Ablation (Phase 1)

Participants undergo the FARAPULSE Pulsed Field Ablation procedure to treat persistent atrial fibrillation

1 day

1 visit (in-person)

Follow-up (Phase 1)

Participants are monitored for safety events and chronic success of the procedure

12 months

Multiple visits over 12 months

Pulsed Field Ablation (Phase 2)

Participants undergo a second phase of the FARAPULSE Pulsed Field Ablation procedure

1 day

1 visit (in-person)

Follow-up (Phase 2)

Participants are monitored for safety events and chronic success of the procedure

12 months

Multiple visits over 12 months

Treatment Details

Interventions

• FARAPULSE Ablation System

Trial Overview The ADVANTAGE AF Study is testing the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System as a treatment option for people with persistent AF who haven't responded well to drugs. It's an open-label study where all participants receive the same intervention using this new ablation system designed specifically for their condition.

Participant Groups

Group I: Pulsed Field Ablation (Phase 2) Experimental Treatment 1 Intervention

PHASE 2 only

Group II: Pulsed Field Ablation (Phase 1) Experimental Treatment 1 Intervention

PHASE 1 only

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

In a study of 1,011 patients undergoing pulmonary vein radiofrequency catheter ablation for atrial fibrillation, the overall complication rate was 3.9%, indicating a relatively low incidence of early complications associated with this procedure.

No procedure-related deaths occurred, and while some complications like peripheral vascular issues and cardiac tamponade were noted, they were generally manageable, suggesting that the procedure is safe, especially compared to earlier years of AF ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. Bertaglia, E., Zoppo, F., Tondo, C., et al.[2016]

The safety and effectiveness of catheter ablation for atrial fibrillation (AF) in routine clinical practice, especially for patients with persistent and long-standing AF, remain uncertain despite positive results from clinical trials.

To address these concerns, a national registry for AF ablation procedures, known as the Safety of Atrial Fibrillation Ablation Registry Initiative, was proposed to monitor outcomes and improve the understanding of this treatment's safety and efficacy in diverse clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: a Cardiac Safety Research Consortium "Incubator" Think Tank. Al-Khatib, SM., Calkins, H., Eloff, BC., et al.[2010]

The first successful cryoablation procedure using a new device was performed on a patient with severe mitral valve insufficiency and paroxysmal atrial fibrillation, indicating a promising advancement in treatment options.

This new device addresses serious complications associated with existing surgical ablation tools, suggesting improved safety and efficacy for patients undergoing atrial fibrillation treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new cryoablation device for surgical therapy of atrial fibrillation. Christiansen, S., Autschbach, R.[2016]

The Cardioblate surgical ablation system utilizes saline-irrigated radiofrequency energy to create electrically isolating lines in atrial tissue, which is crucial for treating atrial fibrillation effectively.

This system provides a comprehensive approach to surgical ablation, showing promising results when compared to other energy sources and traditional methods like the Cox-Maze procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardioblate surgical ablation system. Wahba, A.[2009]

References

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

Catheter Ablation of Long Standing Persistent Atrial Fibrillation: Lessons Learned. [2020]

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

Clinical outcome after radiofrequency catheter ablation of focal atrial fibrillation triggers. [2019]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

The Importance of Arrhythmia Burden for Outcomes and Management Related to Catheter Ablation of Atrial Fibrillation. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Long-term success after catheter ablation of atrial fibrillation]. [2023]

5. Japan pubmed.ncbi.nlm.nih.gov

Long-term benefits following catheter ablation of atrial fibrillation. [2019]

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

Temporal trends in safety and complication rates of catheter ablation for atrial fibrillation. [2022]

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

Population-Based Evaluation of Major Adverse Events After Catheter Ablation for Atrial Fibrillation. [2019]

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

Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. [2016]

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

Planning the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a Collaborative Pan-Stakeholder Critical Path Registry Model: a Cardiac Safety Research Consortium "Incubator" Think Tank. [2010]

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

Developing the Safety of Atrial Fibrillation Ablation Registry Initiative (SAFARI) as a collaborative pan-stakeholder critical path registry model: a Cardiac Safety Research Consortium "Incubator" Think Tank. [2010]

11. Italy pubmed.ncbi.nlm.nih.gov

A new cryoablation device for surgical therapy of atrial fibrillation. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Cardioblate surgical ablation system. [2009]

13. Japan pubmed.ncbi.nlm.nih.gov

Catheter ablation therapy for atrial fibrillation: current advancements in strategies. [2019]

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

Elimination of focal atrial fibrillation with a single radiofrequency ablation: use of a basket catheter in a pulmonary vein for computerized activation sequence mapping. [2019]

15. England pubmed.ncbi.nlm.nih.gov

Cryoballoon vs. open irrigated radiofrequency ablation for paroxysmal atrial fibrillation: long-term FreezeAF outcomes. [2022]