CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPulse Biosciences, Inc.
About this trial
This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure.
Eligibility criteria
Qualifiers
Subject must be between 18 and 85 years of age
Subject is willing and capable of providing Informed Consent to undergo study procedures which includes surgical AF ablation and completing follow-up visits as specified in the clinical study protocol
Subject has history of documented atrial fibrillation within one year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), holter monitor or telemetry strip
Subject is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Ascending aortic aneurysms, or Coronary artery bypass procedures
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
Stand-alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
Previous surgical Maze procedure
Trial design
Treatments tested in this trial
- CellFX® nsPFA™ Cardiac Surgery System
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Pulse Biosciences, Inc.
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov