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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, single-arm trial. The objective of the study is to determine the rate of atrial arrhythmia recurrence after pulmonary vein isolation (PVI) plus posterior wall isolation (PWI) using the Farawave PFA catheter in patients with longstanding persistent atrial fibrillation (AF). The trial will be conducted at as many as 10 US sites. Upon completion of site initiation, enrollment is expected to accrue at a rate of 10 patients per month. Total enrollment is expected to consist of 100 subjects. Accrual is expected to take 18 months, and all patients will be followed for 12 months post randomization. This study will be completed in 2 phases. There will be a 20 subject pilot phase, enrolled at one site (Mount Sinai). After completion of the pilot phase, the FDA will be provided with acute safety data (1 month). During the FDA's review of the pilot phase, enrollment may continue at the initial site. Also, IRB submissions at other prospective sites (up to a total of 10) may be initiated. Upon receipt of the go-ahead from FDA and after consultation with the study sponsor, the second phase of the study (to enroll 100 total subjects) will be performed. This research study currently has approval to enroll 25 patents. Should FDA grant approval to continue the study, the research team will expand as above and update this posting.

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 data supports the idea that Pulsed Field Ablation for Atrial Fibrillation is an effective treatment?

The available research shows that Pulsed Field Ablation (PFA) is effective for treating Atrial Fibrillation (AF). It is designed to target heart tissue while minimizing damage to surrounding areas, which can lead to fewer complications. Studies have shown that PFA is a promising alternative to traditional thermal methods, with high success rates in isolating the pulmonary veins, which is crucial for treating AF. The EU-PORIA registry and other studies have reported positive outcomes, indicating that PFA is both safe and effective in real-world settings. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Farawave PFA catheter for atrial fibrillation?

Research shows that pulsed field ablation (PFA) is effective for treating atrial fibrillation by targeting heart tissue while sparing surrounding areas, leading to fewer complications. The FARAPULSE system, used in Europe, has been shown to be safe and effective in real-world settings, with multiple centers reporting positive outcomes. ^{1 2 3 4 5}

What safety data is available for pulsed field ablation in treating atrial fibrillation?

Pulsed field ablation (PFA) has been shown to be a promising and safe treatment for atrial fibrillation, with studies indicating preferential tissue ablation and minimal damage to non-cardiac tissues, such as the esophagus. The MANIFEST-PF survey and other studies have reported on the real-world performance and safety of PFA, including rare complications. The FARAPULSE system, approved in Europe, has been used in multiple high-volume centers, demonstrating high efficacy and a favorable safety profile. The EU-PORIA registry and other investigations have also highlighted the safety and efficacy of PFA, although clinical data is still emerging. ^{1 3 4 6 7}

Is pulsed field ablation safe for humans?

Pulsed field ablation (PFA) has shown a promising safety profile in treating atrial fibrillation, with studies indicating it causes less damage to non-heart tissues, like the esophagus, compared to other methods. It has been used in real-world settings with positive safety outcomes, although more data is still being gathered. ^{1 3 4 6 7}

Is the Farawave PFA catheter a promising treatment for atrial fibrillation?

Yes, the Farawave PFA catheter is a promising treatment for atrial fibrillation. It uses a new method called pulsed field ablation, which is designed to target heart tissue precisely while avoiding damage to nearby areas. This treatment has been shown to be effective and safe, and it is already being used in Europe with positive results. ^{1 2 3 8 9}

How is the Farawave PFA catheter treatment different from other treatments for atrial fibrillation?

The Farawave PFA catheter uses pulsed field ablation, a new method that targets heart tissue more precisely, reducing damage to surrounding areas compared to traditional heat-based treatments. This approach is expected to be safer and more effective for isolating the pulmonary veins, which are often involved in atrial fibrillation. ^{1 2 3 8 9}

Research Team

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine

William Whang, MD

Principal Investigator

Icahn School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pulsed Field Ablation for Atrial Fibrillation. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Initial experience with pulsed field ablation for atrial fibrillation. [2022]

3. England 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. [2023]

4. England 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. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Pulsed Field Ablation of Atrial Fibrillation: An Initial Australian Single-Centre Experience. [2023]

6. England 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). [2023]

7. Netherlands 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. [2023]

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

Early recurrences predict late therapy failure after pulsed field ablation of atrial fibrillation. [2023]

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

Zero-fluoroscopy ablation with multielectrode pulse field ablation system: Case series. [2023]