CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation

ConditionsAtrial Fibrillation Surgery Ablation of Atrial Fibrillation Clamp Study

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

CellFX® nsPFA™ Cardiac Surgery System
Device
Adult patients presenting to the investigational center that are to undergo non-emergent concomitant cardiac surgical procedure(s), scheduled 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 with history of documented atrial fibrillation within one year prior to enrollment will be evaluated for eligibility and participation in the study.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: CellFX nsPFA Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Rate of acute major adverse events (MAEs)

Acute major adverse events (MAEs) include, cardiac death, stroke, myocardial infarction, transient ischemic attack, or excessive bleeding.

Time frame

Within 30 days post-ablation procedure

Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial box

The ablation procedure includes pulmonary vein isolation and a series of ablation lines to create a "box lesion" on the posterior left atrial free wall. At the conclusion of both the primary and concomitant procedures, exit and/or entrance block will be performed to confirm complete isolation of the pulmonary veins and the left atrial posterior wall.

Time frame

Within 24 hours post-ablation procedure

Secondary outcomes

Proportion of Participants with one or more SAEs

Long-term safety endpoint for the incidence of treatment-emergent adverse events \[Safety and Tolerability\] for subjects having one or more SAEs at each follow-up interval.

Time frame

Up to 12-months post-procedure

Number of Participants with Long-Term Technical Success

Long-term Technical Success of the Pulse Biosciences CellFX® nsPFA™ Cardiac Surgery System is defined as participants having confirmation of electrical isolation of the bilateral pulmonary veins and left atrial box by cardiac electroanatomical mapping 2-6 months post-ablation procedure.

Time frame

60-120 days following the index procedure