CellFX nsPFA cardiac surgery clamp for atrial fibrillation during heart operations

Pulse Biosciences' CellFX nsPFA Cardiac Surgery Clamp System for the Treatment of Atrial Fibrillation During Concomitant Cardiac Surgery

We will test a nanosecond pulsed field ablation (nsPFA) clamp used during heart surgery to see if it reduces atrial fibrillation in adults having other cardiac procedures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Pulse Biosciences, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (St. Helena, California and 1 other locations)
• Trial ID: NCT06959121 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, non-randomized single-arm study enrolling adults with paroxysmal or persistent/longstanding persistent atrial fibrillation who are scheduled for concomitant cardiac surgery. The CellFX nsPFA Cardiac Surgery System will be used to create left and right pulmonary vein isolation and left atrial posterior wall isolation via epicardial-only or combined epicardial/endocardial lesions, together with left atrial appendage exclusion or removal. The primary effectiveness endpoint is freedom from AF/AFL/AT episodes longer than 30 seconds and freedom from new or increased Class I/III antiarrhythmic drugs after a 90-day blanking period through six months, adjudicated by a core lab. The primary safety endpoint is the incidence of acute major adverse events (death, stroke, MI, TIA, or major bleeding) within 30 days.

Who should consider this trial

Good fit: Adults 18–85 with documented paroxysmal or persistent/longstanding persistent atrial fibrillation who are scheduled for non-emergent cardiac surgery on cardiopulmonary bypass (for example valve repair/replacement or CABG) and can provide informed consent and complete follow-up are ideal candidates.

Not a fit: Patients who are not having concomitant cardiac surgery, who require emergent procedures, who have contraindications to the device or anticoagulation, or who fall outside the enrollment age/arrhythmia criteria are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the nsPFA clamp could enable effective, targeted atrial ablation during routine cardiac surgery with potentially less collateral thermal injury and improved short-term freedom from atrial arrhythmias.

How similar studies have performed: Catheter-based pulsed field ablation has shown promising early results for pulmonary vein isolation, but the use of epicardial nsPFA clamps during open cardiac surgery is relatively novel with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

* 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
* Left ventricular ejection fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)
* Subject has a life expectancy of at least 5 years
* Subject currently lives within a reasonable commuting distance of the investigational site and plans to remain geographically stable through 12 month follow up

Exclusion Criteria:

* 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
* Prior cardiac surgery including prior cardiac surgical ablation
* Left Atrial diameter ≥ 6cm
* Wolff-Parkinson-White syndrome or other Supra-Ventricular Arrhythmia, Atrioventricular (AV) nodal reentry
* Documented history of persistent or long standing persistent atrial fibrillation longer than 10 years
* Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or atrial septal defect repair/PFO and ascending aorta
* Prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation)
* Subjects that are on an AAD for ventricular arrhythmia.
* STS Predicted Risk of Mortality (STS PROM) of 10 or higher
* Class III or IV New York Heart Association (NYHA) heart failure symptoms
* Prior history of stroke within 6 months
* Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment
* Need for emergent cardiac surgery (per sit-to-stand (STS) test definition)
* Known carotid artery stenosis greater than 80%
* Current diagnosis of active systemic infection
* Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
* Renal failure requiring dialysis or hepatic failure (significant liver dysfunction with markedly significant elevation of liver enzymes, such as cirrhosis with decompensation, portal hypertension, or a history of hepatic failure)
* A known drug and/or alcohol addiction
* Mental impairment or other conditions that may not allow the subject to understand the nature, significance, and scope of the study
* Pregnancy or desire to get pregnant within 12 months of the study treatment
* Preoperative need for an intra-aortic balloon pump or intravenous inotropes
* Subjects who have been treated with thoracic radiation
* Subjects in current chemotherapy
* Subjects on long-term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases)
* Subjects with known hypertrophic obstructive cardiomyopathy
* Subjects with known cold agglutinin
* Subject has a contraindication to anticoagulation (e.g., a bleeding or clotting disorder such as Idiopathic Thrombocytopenic Purpura (ITP))
* Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
* Body mass index \> 45 kg/m2
* Any diagnosed connective tissue disorder
* Severe Chronic Obstructive Pulmonary Disease (COPD) per sit-to-stand (STS) test definition
* Use of any other investigational drug, therapy, or device within 30 days before enrollment or concurrent participation in another research study

Where this trial is running

St. Helena, California and 1 other locations

• Adventist Heart Institute: Adventist Health St. Helena — St. Helena, California, United States (Recruiting)
• Cardiac Surgery Clinic | Frankel Cardiovascular Center — Ann Arbor, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: Matthew A. Romano, MD — University of Michigan, Cardiac Surgery Clinic | Frankel Cardiovascular Center
• Study coordinator: Shweta Kalpa, MD

Conditions Atrial Fibrillation; Maze Procedure; AF; Ablation; nsPFA