Pulsed Field Ablation for Atrial Fibrillation

(LS-PersAFone Trial)

Overseen By William Whang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vivek Reddy

Disqualifiers: Prior atrial ablation, Hypertrophic cardiomyopathy, Major cardiac surgery, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, the Farawave PFA catheter (a device used for ablation), for individuals with longstanding persistent atrial fibrillation, a type of irregular heartbeat lasting over a year. The goal is to determine if this treatment can reduce the recurrence of atrial arrhythmias (abnormal heart rhythms) after a procedure called pulmonary vein and posterior wall isolation. The trial seeks participants who have never undergone an ablation procedure for AF and have a left ventricular ejection fraction above 30%. This is an opportunity to contribute to research that could enhance the management of this heart condition. As an unphased trial, it offers a unique chance to participate in pioneering research that could significantly improve heart health management.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

Will I have to stop taking my current medications?

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 the Farawave PFA catheter is safe for atrial fibrillation treatment?

Research has shown that the Farawave PFA catheter, used to treat atrial fibrillation (AF), offers promising safety results. In one study, only 2.3% of patients experienced safety issues, including side effects like inflammation of the heart's lining and heart attacks. Another study found that serious problems, such as fluid build-up around the heart, strokes, or hospitalizations for heart failure, were rare.

Long-term studies also found that major issues, like fluid build-up around the heart or brief strokes, occurred in only about 1.1% of patients. Notably, these studies reported no cases of sudden narrowing of the arteries or narrowing of the pulmonary vein.

Overall, the Farawave PFA catheter appears well-tolerated by most patients, with serious side effects being uncommon. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Farawave PFA catheter is unique because it uses pulsed field ablation (PFA), a novel approach that precisely targets heart tissue without causing thermal damage, unlike traditional radiofrequency or cryoablation methods. Researchers are excited because PFA can potentially reduce procedure time and minimize complications, offering a safer and more efficient treatment for patients with longstanding persistent atrial fibrillation. This non-thermal technique could lead to better patient outcomes and a quicker recovery, setting it apart from current standard treatments.

What evidence suggests that the Farawave PFA catheter is effective for atrial fibrillation?

Research has shown that the Farawave PFA catheter, which participants in this trial will receive, holds promise for treating atrial fibrillation (AF). In one study, 63.5% of patients did not experience irregular heartbeats a year after treatment, indicating that more than half did not have a return of AF during that period. The treatment uses pulsed electric fields to target heart tissue, potentially reducing AF symptoms. Early results suggest it could be a safe and effective option for those with ongoing AF. ^{1 2 3 5 6}

Who Is on the Research Team?

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine

William Whang, MD

Principal Investigator

Icahn School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with long-standing persistent atrial fibrillation (AF) lasting more than a year, who are planning their first AF ablation procedure and have a left ventricular ejection fraction above 30%. It's not for those with prior heart surgeries, recent major cardiac events or procedures, or life expectancy under one year.

Inclusion Criteria

I am older than 18 years.

Your heart's pumping function is good, with an ejection fraction of more than 30% as checked within the last 6 months.

I have had atrial fibrillation for more than a year without stopping.

Exclusion Criteria

I have had a procedure to open my carotid artery.

You are not expected to live for more than one year.

I have not had major heart surgery in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Phase

20 subjects enrolled at one site to assess acute safety data

1 month

Main Treatment Phase

Pulmonary vein isolation (PVI) and Posterior wall isolation (PWI) using the Farawave PFA catheter

18 months for enrollment

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Farawave PFA catheter

Trial Overview

The study tests the Farawave PFA catheter's effectiveness in preventing atrial arrhythmia recurrence after isolating pulmonary veins and the posterior wall in patients. The trial will enroll up to 100 participants across multiple US sites and includes an initial pilot phase followed by FDA review.

How Is the Trial Designed?

Group I: Patients with longstanding persistent atrial fibrillation (AF) Experimental Treatment 1 Intervention

All subjects will undergo Pulmonary vein isolation (PVI) and Posterior wall isolation (PWI) with the Farapulse catheter.

Farawave PFA catheter is already approved in United States, European Union for the following indications:

Approved in United States as Farawave PFA catheter for:

• Paroxysmal atrial fibrillation (AFib)
• Long-standing persistent atrial fibrillation (AF)

Approved in European Union as Farawave PFA catheter for:

• Paroxysmal atrial fibrillation (AFib)

Who Is Running the Clinical Trial?

Vivek Reddy

Lead Sponsor

Trials

23

Recruited

5,700+

Published Research Related to This Trial

Pulsed field ablation (PFA) for pulmonary vein isolation in atrial fibrillation shows a high single-procedure success rate of 74% for arrhythmia-free survival at a median follow-up of 365 days, indicating its efficacy in treating AF.

The procedure has a favorable safety profile with major complications occurring in only 1.7% of cases, and median procedure times were relatively short at 58 minutes, suggesting PFA is a safe and efficient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUropean real-world outcomes with Pulsed field ablatiOn in patients with symptomatic atRIAl fibrillation: lessons from the multi-centre EU-PORIA registry. Schmidt, B., Bordignon, S., Neven, K., et al.[2023]

Pulsed field ablation (PFA) for atrial fibrillation (AF) was performed safely in 97 patients, with a high success rate of 100% in isolating pulmonary veins and an 87% freedom from atrial arrhythmias at 180 days follow-up.

The procedure had a median time of 74 minutes and low complication rates, with only 2% experiencing pseudoaneurysm complications, and no serious adverse events like stroke or pulmonary vein stenosis, indicating PFA's potential as an effective alternative to traditional ablation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed Field Ablation of Atrial Fibrillation: An Initial Australian Single-Centre Experience. Lee, XW., Freeman, BM., Gunthorpe, NG., et al.[2023]

Pulsed field ablation (PFA) demonstrated a 100% success rate in isolating pulmonary veins in 23 patients, with significantly larger acute antral lesions compared to cryoballoon (CB) ablation, indicating its potential efficacy in treating atrial fibrillation.

While PFA showed no major complications like phrenic nerve injury or bleeding, one patient experienced a stroke, highlighting the need for further studies to assess long-term safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed field ablation for pulmonary vein isolation: real-world experience and characterization of the antral lesion size compared with cryoballoon ablation. Blockhaus, C., Guelker, JE., Feyen, L., et al.[2023]

In a study of 100 patients with symptomatic atrial fibrillation, the pulsed field ablation (PFA) catheter demonstrated effective pulmonary vein isolation (PVI) in all cases, confirming its efficacy in treating AF.

The procedure was found to be safe, with only two cases of bleeding at the access site reported, and it was quick to learn, showing no significant difference in procedure times between senior and junior operators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with pulsed field ablation for atrial fibrillation. Magni, FT., Mulder, BA., Groenveld, HF., et al.[2022]

Pulsed field ablation (PFA) using the CENTAURI System achieved 100% pulmonary vein isolation in 82 patients with atrial fibrillation, demonstrating high efficacy with a first-pass isolation rate of 92.2%.

The study reported a favorable safety profile, with only four serious adverse events, indicating that optimized PFA is a viable and safe treatment option for atrial fibrillation when integrated with existing ablation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed field ablation using focal contact force-sensing catheters for treatment of atrial fibrillation: acute and 90-day invasive remapping results. Anić, A., Phlips, T., Brešković, T., et al.[2023]

In a study involving 1758 patients across 24 clinical centers, pulsed field ablation (PFA) demonstrated a remarkable success rate of 99.9% for pulmonary vein isolation, indicating its high efficacy in treating atrial fibrillation.

The safety profile of PFA was favorable, with no oesophageal complications reported and a low major complication rate of 1.6%, although there were still some serious risks like pericardial tamponade and stroke that need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). Ekanem, E., Reddy, VY., Schmidt, B., et al.[2023]

Pulsed field ablation (PFA) is a new and effective treatment for atrial fibrillation (AF) that selectively targets cardiac tissue, potentially reducing damage to surrounding non-cardiac tissues.

The FARAPULSE ablation system is the first PFA device approved for clinical use in Europe, and early clinical experiences suggest it is both safe and effective for pulmonary vein isolation in patients with AF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed Field Ablation for Atrial Fibrillation. Schaack, D., Schmidt, B., Tohoku, S., et al.[2023]

Pulse field ablation (PFA) is a new, nonthermal method for treating atrial fibrillation that has shown promise in clinical settings.

In a case series of three patients, a zero-fluoroscopy approach using intracardiac echocardiography was successfully implemented, potentially reducing radiation exposure during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zero-fluoroscopy ablation with multielectrode pulse field ablation system: Case series. Rauber, M., Manninger, M., Eberl, AS., et al.[2023]

In a study of 231 patients undergoing pulsed field ablation for atrial fibrillation, 21% experienced early recurrences of atrial tachyarrhythmia, which were found to be an independent predictor of late recurrence of atrial fibrillation or atrial tachycardia.

The study showed a 1-year freedom from atrial fibrillation or atrial tachycardia rate of 74.2%, with significant differences based on the type of atrial fibrillation, indicating that patients with paroxysmal atrial fibrillation had better outcomes than those with persistent atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early recurrences predict late therapy failure after pulsed field ablation of atrial fibrillation. Plank, K., Bordignon, S., Urbanek, L., et al.[2023]

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07130773

Comparative Intra-procedural Evaluation of Farapulse and ...

Our study evaluates whether the FARAWAVE Nav catheter, without pre-ablation CT, allows to reduce fluoroscopy time and total patient radiation ...

3.

bostonscientific.com

bostonscientific.com/content/dam/bostonscientific/ep/farapulse/ADVANTAGE_Clinical_Data_Summary.pdf

ADVANTAGE AF US IDE

FARAWAVE. NAV PFA Catheter was not used in this study. Page 2. Atrial Arrhythmia Burden. TTM and Holter data was used to calculate the AA ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11595090/

Pulsed Field Ablation in Atrial Fibrillation: Initial Experience ...

The primary efficacy endpoint was freedom from atrial arrhythmia recurrence after a 90-day blanking period at 12 months. Safety endpoints ...

5.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf23/P230030C.pdf

FARAWAVE™

Study Conclusion. The ADVENT Trial results constitute valid scientific evidence that gives reasonable assurance of the safety and effectiveness of the FARAPULSE ...

6.

academic.oup.com

academic.oup.com/europace/article/26/3/euae053/7612551

Long-term outcomes of the pentaspline pulsed-field ablation ...

The composite safety endpoint occurred in two patients (1.1%), one tamponade and one transient ischaemic attack. There was no coronary spasm, PV stenosis, or AE ...