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NCT06128174 · ClinicalTrials.gov registry record · NA
LS-PersAFone: Pulsed Field Ablation for Long-Standing Persistent Atrial Fibrillation
A NA study, sponsored by Vivek Reddy.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT06128174 is a NA study that has completed, run by Vivek Reddy. The registered enrollment target is 20 participants.
The verdict
NCT06128174, a NA study, has completed, sponsored by Vivek Reddy.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Farawave PFA catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-01-23 |
| Est. Completion | 2025-12-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06128174
The ClinicalTrials.gov registry entry for NCT06128174 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vivek Reddy, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Farawave PFA catheter is the first listed.
NCT06128174 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06128174 about?
NCT06128174 is a clinical study titled "LS-PersAFone: Pulsed Field Ablation for Long-Standing Persistent Atrial Fibrillation". 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...
What is the current status of trial NCT06128174?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2024-01-23. Estimated completion is 2025-12-08.
What interventions are being tested in trial NCT06128174?
The interventions under investigation include: Farawave PFA catheter (DEVICE).
Who is sponsoring clinical trial NCT06128174?
This trial is sponsored by Vivek Reddy, which has 20 total clinical trials registered on ClinicalTrials.gov.
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