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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CellFX nano-pFA 360 Endocardial Ablation Catheter System
DeviceThe CellFX nano-PFA 360 Endocardial Ablation Catheter System includes the nano-pFA 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 for the treatment of arrhythmias, including atrial fibrillation. The nano-PFA 360 Catheter ablates cardiac tissue using nonthermal nano-second pulses of electrical energy. Nanosecond Pulsed Field Ablation (nsPFA or nano-PFA) 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 ability of the cell and internal organelles to maintain cellular homeostasis by creating nanopores in lipid membranes, ultimately leading to regulated cell death (RCD).
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: CellFX nano-PFA Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of primary safety major adverse events (MAEs)
The primary safety endpoint includes major adverse events (MAEs) specifically related to the device or ablation procedure for the following * Asymptomatic Cerebral Embolism * Arterioesophageal Fistula * Bleeding Requiring Transfusion * Cardiac Perforation/Tamponade * Death * Esophageal Injury Resulting in Perforation * Myocardial Infarction * Pericarditis Requiring Intervention or Hospitalization * Phrenic Nerve Injury/Diaphragmatic Paralysis * Pulmonary Edema/Respiratory Insufficiency * Pulmonary Vein Stenosis (≥70% diameter reduction) * Stroke or Transient Ischemic Attack * Vagal Nerve Injury Resulting in Esophageal Dysmotility or Gastroparesis * Vascular Access Complication Requiring Intervention
Time frame
Within 30 days post-ablation procedure2
Proportion of participants achieving acute procedural success.
Acute procedural success is achieving entrance block of the pulmonary veins
Time frame
Immediately post-ablation procedureSecondary outcomes
1
Proportion of participants reporting one or more significant adverse events (SAEs)
Safety related to the reporting one or more SAEs for each follow-up interval as described. * Atrio-esophageal fistula (up to 3-month visit) * Pulmonary Vein (PV) stenosis (up to 3-month visit) * Subjects presenting with Primary SAEs up to the 12-month post- procedure follow-up * Subjects presenting with any AEs or SAEs up to the 12-month post- procedure follow-up
Time frame
Within 12 months post-ablation procedure2
Proportion of participants achieving long-term technical success
Long-term technical success is defined as electrical isolation of the pulmonary veins (PVI) assessed during an electroanatomical mapping procedure.
Time frame
Within 3 months post-ablation procedure3
Proportion of participants achieving treatment success
Treatment success is defined by freedom from the following failures: 1. Recurrence of atrial fibrillation, atrial flutter, atrial tachycardia (AF/AFL/AT) as evidenced by episodes ≥ 30 secs on transtelephonic monitoring (TTM), Holter monitoring, or continuously 12-lead electrocardiogram (ECG) 2. Cardioversion for atrial fibrillation (AF) /atrial flutter (AFL) / atrial tachycardia (AT) 3. Repeat ablation failure 4. Antiarrhythmic Drugs (AADs) failure 5. Surgical treatment for AF/AFL/AT after the index procedure
Time frame
Within 12 months post-ablation procedureSponsors and contacts
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Source ClinicalTrials.gov