CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPulse Biosciences, Inc.
About this trial
The objective of this study is to demonstrate initial safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with atrial fibrillation.
Eligibility criteria
Qualifiers
Subject must be ≥ 18 and ≤ 75 years of age on the day of enrollment
Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-up visits and tests associated with this clinical study
Subjects with PAF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip
Subjects who have failed at least one antiarrhythmic drug (AAD; class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as shown by recurrent symptomatic AF, or intolerance to the AAD or AV nodal blocking agents
Disqualifiers
Subject has an implantable electronic medical device. (i.e., pacemaker, ICD or CRT) or left atrial appendage device
Subject has a prosthetic heart valve
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
AF episodes lasting > 7 days
Trial design
Treatments tested in this trial
- CellFX nano-pFA 360 Endocardial Ablation Catheter System
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov