Clinical trial NCT06959121: CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation
Official title: Randomized Controlled Trial of Pulse Biosciences' CellFX® Nanosecond Pulsed Field Ablation Cardiac Surgery Clamp System for Treatment of Atrial Fibrillation During Concomitant Cardiac Surgery Compared to a Control Arm Not Receiving Ablation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Maze Procedure
AF
Ablation
Lead sponsor: Pulse Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-06
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-Arm Study.
Primary purpose: TREATMENT

Brief summary: The primary objective of this RCT 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.

Detailed description: The study design is a prospective, multicenter, two-arm, randomized, controlled study. Adult subjects who are clinically indicated will either undergo a concomitant cardiac surgical procedure with ablation (of left and right pulmonary veins as well as roof and floor lesions to form a box) with left atrial appendage removal OR undergo a concomitant cardiac surgical procedure with left atrial appendage removal and no ablation.

Subjects will be randomized in a 2:1 ratio (treatment: control). Stratification at the time of randomization will occur based on site, AF type (Paroxysmal, Non-Paroxysmal) and Cardiac Surgical Procedure (involving mitral valve/no mitral valve involvement).

The study's primary endpoint will be assessed by a blinded core lab 6 months after the ablation procedure. Subjects are blinded until they reach the 6-month follow-up visit.

The primary safety endpoint is the incidence of acute major adverse events (MAEs), which includes death, stroke, myocardial infarction (MI), transient ischemic attack (TIA), or excessive bleeding (Bleeding Academic Research Consortium (BARC) 3b, 4, or 5) within 30 days post-concomitant surgical procedure. These events may be related to either the cardiac surgical procedure or the ablation procedure. An independent Clinical Events Committee (CEC) will review and adjudicate all MAE events.

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 atrial fibrillation 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

Primary outcomes:
measure: Freedom from atrial fibrillation/atrial flutter/atrial tachycardia
timeFrame: 3-months through 6 months post-index procedure
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Within 30 days post-concomitant surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: