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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CellFX nsPFA Cardiac Catheter System
DeviceThe CellFX nsPFA Cardiac Catheter System includes the nsPFA 360 Endocardial Ablation Catheter, CellFX Console, switcher box/adapter, and sensing cable. The System is a proprietary endocardial catheter system designed for use in cardiac electrophysiology procedures to treat arrhythmias, including atrial fibrillation. The nano-PFA 360 Catheter ablates cardiac tissue using nonthermal nanosecond pulses of electrical energy. nsPFA is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of high-amplitude electrical energy to tissue via bipolar electrodes. The pulses disrupt the cell's and internal organelles' ability to maintain cellular homeostasis by creating nanopores in lipid membranes, ultimately leading to regulated cell death (RCD).
Treatment groups
215 Participants
are divided into 1 treatment groupGroup A: nsPFA Cardiac Catheter System Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with freedom from primary safety endpoint
The primary safety endpoint is freedom from a primary safety endpoint for the following: * Cerebrovascular accident/Stroke * Thromboembolism * Myocardial infarction * Severe Pericarditis (requiring intervention) * Transient ischemic attack * Vagal nerve injury resulting in esophageal dysmotility or gastroparesis * Major vascular access complications * Bleeding * Pulmonary edema * Heart Block * Permanent Phrenic Nerve paralysis * Device or Procedure-related Death * CellFX System-related or PFA procedure-related cardiovascular and/or pulmonary adverse event that prolongs or requires hospitalization for more than 48 hours, excluding recurrent atrial fibrillation/atrial flutter/atrial tachycardia (AF/AFL/AT) * Cardiac tamponade/perforation * Significant acute kidney injury secondary to hemolysis * Pulmonary vein stenosis * Esophageal perforating complications
Time frame
Within 7 days, 30 days, and 6 months post-ablation procedure2
Proportion of participants achieving freedom from treatment failure.
Acute procedural failure is defined as the inability to isolate all targeted pulmonary veins (PV) (minimally assessed for entrance block and, where assessable, exit block) during the index procedure or PV ablation using a non-study device in the left atrium
Time frame
6 months post-ablationSecondary outcomes
1
Proportion of participants achieving acute procedural success
Acute Procedural Success: Ability to isolate all pulmonary veins and no ablation using a non-study device in the left atrium.
Time frame
Immediately post-ablation procedureSponsors and contacts
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Source ClinicalTrials.gov