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Procedure

Pulsed Field Ablation for Atrial Fibrillation (LS-PersAFone Trial)

N/A
Recruiting
Led By Vivek Reddy, MD
Research Sponsored by Vivek Reddy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years
Long-standing Persistent AF (>1 year continuous AF)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study at 12 months
Awards & highlights

LS-PersAFone Trial Summary

This trial will look at how well a Farawave PFA catheter works to reduce atrial arrhythmia recurrence after pulmonary vein isolation (PVI) & posterior wall isolation (PWI) in patients with longstanding persistent atrial fibrillation (AF). 25 patients enrolled, up to 100 expected across 10 US sites over 18 months.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of the Farawave PFA catheter aren't detailed here, similar procedures may include risks like bleeding at the catheter site, heart tissue damage, vein inflammation or narrowing, irregular heartbeats, and other complications related to heart ablations.

LS-PersAFone Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have had atrial fibrillation for more than a year without stopping.
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I am scheduled for my first AF (atrial fibrillation) ablation.

LS-PersAFone Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post 3 month blanking period till end of study at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and post 3 month blanking period till end of study at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with freedom from recurrent atrial arrhythmias
Secondary outcome measures
Proportion with post-blanking period AF burden <12% by device interrogation

LS-PersAFone Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with longstanding persistent atrial fibrillation (AF)Experimental Treatment1 Intervention
All subjects will undergo Pulmonary vein isolation (PVI) and Posterior wall isolation (PWI) with the Farapulse catheter.

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Who is running the clinical trial?

Vivek ReddyLead Sponsor
20 Previous Clinical Trials
5,331 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
1,050 Patients Enrolled for Atrial Fibrillation
Vivek Reddy, MDPrincipal InvestigatorIcahn School of Medicine
33 Previous Clinical Trials
11,271 Total Patients Enrolled
18 Trials studying Atrial Fibrillation
5,837 Patients Enrolled for Atrial Fibrillation
William Whang, MDPrincipal InvestigatorIcahn School of Medicine
2 Previous Clinical Trials
24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for participants in this trial?

"According to the data hosted on clinicaltrials.gov, it appears that this specific medical trial is not presently recruiting patients; however, there are 507 other studies actively accepting participants right now. Initially posted in November 1st 2023 and last edited on the 7th of that same month, this research project is currently inactive."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
LS-PersAFone: Pulsed Field Ablation for Long-Standing Persistent Atrial Fibrillation
Vivek Reddy 2024. "LS-PersAFone: Pulsed Field Ablation for Long-Standing Persistent Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06128174.
~17 spots leftby Jun 2025
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