FARAPULSE Ablation for Atrial Fibrillation

(ADVANTAGE AF Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety and effectiveness of the FARAPULSE Ablation System for individuals with persistent atrial fibrillation (AF) that doesn't respond to medication and causes symptoms. It explores a new treatment method for AF using energy pulses to target heart tissue. Participants should have experienced continuous AF for more than a week but less than a year, despite ineffective medications. This trial may suit those with ongoing AF symptoms, such as heart palpitations or shortness of breath, despite medication efforts. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for AF.

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 prior data suggests that the FARAPULSE Ablation System is safe for treating atrial fibrillation?

Research has shown that the FARAPULSE Ablation System is generally safe. In one study, only about 2.1% of patients experienced serious side effects, indicating that major complications were rare. Another large study with over 17,000 patients found that the pulsed field ablation method used in FARAPULSE caused less unintended harm compared to other treatments. This suggests that most patients tolerate the treatment well. While some patients experienced issues like inflammation of the heart lining or a heart attack, these were uncommon. Overall, the FARAPULSE Ablation System appears to be a safe option for treating atrial fibrillation, a condition where the heart beats irregularly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FARAPULSE Ablation System because it offers a new way to treat atrial fibrillation using pulsed electric fields, rather than the traditional heat-based ablation methods like radiofrequency or cryoablation. This technique, known as pulsed field ablation, selectively targets and disrupts the heart tissue responsible for irregular rhythms while potentially minimizing damage to surrounding tissues. This could lead to fewer complications and a quicker recovery for patients. The precision and safety profile of this approach are what make it stand out in the field of atrial fibrillation treatments.

What evidence suggests that the FARAPULSE Ablation System is effective for atrial fibrillation?

Research has shown that the FARAPULSE Ablation System holds promise for treating atrial fibrillation (AF), a type of irregular heartbeat. One study found that 67.7% of people with a persistent form of AF experienced significant improvement after 12 months. Another study reported that 63.5% of patients remained free from AF after one year. For those concerned about recurring heart flutters, a study indicated that 97.2% of participants were free from these episodes. These results suggest that this treatment could be a strong option for people whose AF isn't well-managed by medication. Participants in this trial will join one of two phases, each testing the FARAPULSE Ablation System. ^{1 3 5 6 7}

Who Is on the Research Team?

Vivek Reddy, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

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 willing and able to give my consent for treatment.

I am willing and able to attend all tests at the clinical trial center.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.515

Pulsed Field Ablation for Persistent Atrial Fibrillation Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation ...

2. academic.oup.com academic.oup.com/europace/article/27/9/euaf182/8244658

one-year outcomes of the FARADISE registry | EP Europace The study demonstrates high clinical effectiveness at 12-months: 80.8% in paroxysmal and 67.7% in non-paroxysmal atrial fibrillation (AF) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0735109725059911

Pulsed Field Ablation for Persistent Atrial Fibrillation Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.074485

Pulsed Field Ablation of Persistent Atrial Fibrillation With ... Freedom from recurrent atrial flutter was 97.2%. Detailed analysis of the full insertable cardiac monitor data revealed freedom from AA of ≥30 ...

5. farapulse.com farapulse.com/us/en/home.html

FARAPULSE™ Pulsed Field Ablation (PFA) System Studies have shown that people who have an ablation earlier were more likely to have better symptom control, less AFib over time, and a lower risk of ...

6. nature.com nature.com/articles/s41591-024-03114-3

Safety of pulsed field ablation in more than 17000 patients ... Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with ...

7. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.037959

Does Age Impact Safety and Efficacy During Pulse‐Field ... Using the FARAPULSE system for atrial fibrillation ablation in older patients demonstrated swift, safe, and effective acute outcomes.