CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPulse Biosciences, Inc.
About this trial
The primary objective of this Pivotal study is to demonstrate the safety and effectiveness of the Pulse Biosciences nsPFA™ Cardiac Surgery System in treating atrial fibrillation during concomitant cardiac surgical procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must be between 18 and 85 years of age
Subject is willing and capable of providing Informed Consent to undergo study procedures which include the potential for surgical AF ablation, and completion of follow-up visits as specified in the clinical study protocol
Subject has history of documented paroxysmal atrial fibrillation (AF that is intermittent and terminates within ≤ 7 days of onset) or persistent/longstanding persistent atrial fibrillation (AF that is continuous and sustains for > 7 days and requires intervention) within one year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor or telemetry strip from the study hospital or an outside physician
Subject is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery via sternotomy for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Ascending aortic aneurysms, Atrial Septal Defect (ASD)/Patent Foramen Ovale (PFO) or Coronary artery bypass procedures
Disqualifiers
Subject has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter-defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) or left atrial appendage (LAA) device
Subject has history or known to have LAA clot
Subject has a prosthetic heart valve
Stand- alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
Trial design
Design model
Single group
Treatments tested in this trial
CellFX® nsPFA™ Cardiac Surgery System
DeviceParticipants will receive cardiac ablation with the CellFX® nsPFA™ Cardiac Clamp
Treatment groups
135 Participants
are divided into 1 treatment groupGroup A: CellFX nsPFA ClampExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from atrial fibrillation/atrial flutter/atrial tachycardia
Freedom from AF/AFL/AT of 30 seconds or greater duration and freedom for use of new or increased dose of previously failed Class I or III antiarrhythmic drugs (AADs) prescribed to treat atrial arrhythmias.
Time frame
3-months through 6 months post-index procedure2
Incidence of Treatment-Emergent Adverse Events
Rate of acute major adverse events (MAEs) which includes death, stroke, myocardial infarction (MI), and transient ischemic attack (TIA) or excessive bleeding (Bleeding Academic Research Consortium (BARC) 3b, 4 or 5).
Time frame
Within 30 days post-concomitant surgical procedureSecondary outcomes
1
Acute electrical isolation of the pulmonary veins
Acute electrical isolation of the left and right pulmonary veins and left atrial posterior wall by means of either intraoperative entrance or exit block testing
Time frame
Immediately post-ablation procedure2
Freedom from atrial fibrillation/atrial flutter/atrial tachycardia
Freedom from AF/AFL/AT of 30 seconds and freedom from use of new or increased dose of previously failed Class I or III AADs prescribed to treat atrial arrhythmias
Time frame
Within 12 months post-ablation procedure3
Patient-Reported Outcome Measures (PROMs) for quality of life assessing well-being across physical, mental, and social domains
Quality of Life (QoL) as measured using AFEQT and SF-12 (Physical Component Summary (PCS), Mental Component Summary (MCS) and General Health (GH))
Time frame
6 and 12 months post-ablation procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pulse Biosciences, Inc.
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov