NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPulse Biosciences, Inc.
About this trial
The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF).
Eligibility criteria
Qualifiers
Age 18 through 85 years old (or older than 18 if required by local law)
Failure of at least one AAD (class I or III) for AF as evidenced by recurrence of symptomatic AF, or intolerable side effects due to AAD.
Participant is willing and capable of providing Informed Consent
Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by study investigators
Disqualifiers
Left atrial diameter ≥5.5 cm (anteroposterior)
Any cardiac surgery
Myocardial infarction
Percutaneous Coronary Intervention (PCI) / Percutaneous Coronary Intervention (PTCA) or coronary artery stenting
Trial design
Treatments tested in this trial
- CellFX nsPFA Cardiac Catheter System
Treatment groups
215 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov