LS-PersAFone: Pulsed Field Ablation for Long-Standing Persistent Atrial Fibrillation

NCT06128174 | Completed DMC FDA Device

• 1 other identifier: STUDY-23-01039
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Long-standing Persistent AF

Keywords

Long-standing Persistent AF; Persistent Afib greater than 1 year; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of participants with freedom from recurrent atrial arrhythmias

  Number of participants with freedom from recurrent atrial arrhythmias (AF/AT/AFL) (post 3-month blanking), assessed as time to first recurrence. AF/AT/AFL will be defined as an episode of the corresponding arrhythmia that is recorded for review, where the recording contains at least 30 seconds of continuous interpretable signal. An exception is a 12-lead ECG where the arrhythmia occurs during the entire tracing and the continuous interpretable signal is 10 seconds or longer.

  post 3 month blanking period till end of study at 12 months

Secondary Outcomes (1)

• Proportion with post-blanking period AF burden <12% by device interrogation

  end of study at 12 months

Study Arms (1)

Patients with longstanding persistent atrial fibrillation (AF)

EXPERIMENTAL

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

Device: Farawave PFA catheter

Interventions

Farawave PFA catheter DEVICE

The FARAWAVE Pulsed Field Ablation Catheter (FARAWAVE Catheter) is a flexible tube with electrodes at the end, which is inserted through a blood vessel in your groin. The study doctor will use the FARAWAVE Catheter to deliver the pulsed electrical energy to ablate (destroy) the heart tissue. This process is designed to create a scar in the heart tissue, stopping the unwanted electrical signals that cause the atrial fibrillation.

Patients with longstanding persistent atrial fibrillation (AF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Long-standing Persistent AF (\>1 year continuous AF)
• Planned for a first-ever AF ablation procedure
• Left ventricular ejection fraction \>30% (as assessed within 6 months of randomization)

You may not qualify if:

• Prior left atrial ablation or left atrial surgery (including mitral valve surgery)
• Hypertrophic cardiomyopathy
• Major cardiac surgery within 6 months preceding the consent date
• Within 3 months preceding the consent date:
• Stroke, TIA, intracranial bleeding
• Any thromboembolic event
• Carotid stenting or endarterectomy
• Life expectancy less than one year

Sponsors & Collaborators

• Vivek Reddy: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

• William Whang, MD

  Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: EP Division Director, Professor

Model Details: Prospective Multicenter Single-Arm Investigator-Initiated IDE study

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: January 23, 2024
• Primary Completion: November 24, 2025
• Study Completion: December 8, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)