CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation

NCT06959121 | Recruiting DMC FDA Device

• 1 other identifier: NP-PCP-041
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Maze Procedure; AF; Ablation; Atrial Fibrillation

Keywords

nsPFA

Outcome Measures

Primary Outcomes (2)

• 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.

  3-months through 6 months post-index procedure

• 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).

  Within 30 days post-concomitant surgical procedure

Secondary Outcomes (3)

• Acute electrical isolation of the pulmonary veins

  Immediately post-ablation procedure

• Freedom from atrial fibrillation/atrial flutter/atrial tachycardia

  Within 12 months post-ablation procedure

• Patient-Reported Outcome Measures (PROMs) for quality of life assessing well-being across physical, mental, and social domains

  6 and 12 months post-ablation procedure

Study Arms (1)

CellFX nsPFA Clamp

EXPERIMENTAL

Adult subjects who are eligible to participate will undergo a concomitant cardiac surgical procedure with nsPFA ablation (of left and right pulmonary veins as well as roof and floor lesions to form a box) and treatment of left atrial appendage.

Device: CellFX® nsPFA™ Cardiac Surgery System

Interventions

CellFX® nsPFA™ Cardiac Surgery System DEVICE

Participants will receive cardiac ablation with the CellFX® nsPFA™ Cardiac Clamp

CellFX nsPFA Clamp

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead
• Avania: collaborator

Study Sites (2)

Adventist Heart Institute: Adventist Health St. Helena

St. Helena, California, 94574, United States

RECRUITING

Cardiac Surgery Clinic | Frankel Cardiovascular Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew A. Romano, MD

  University of Michigan, Cardiac Surgery Clinic | Frankel Cardiovascular Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shweta Kalpa, MD

CONTACT

(800) 543-3695; Shweta.Kalpa@pulsebiosciences.com

William A. Knape

CONTACT

(919) 757-2033; bknape@pulsebiosciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-Arm Study.

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)