CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation

NCT ID: NCT06355063

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

This study is a prospective, multicenter, single arm, non-randomized, feasibility study. Adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box. All subjects will return to the hospital between 60-120 days post-surgical ablation procedure to undergo a cardiac electrophysiology study with electroanatomical mapping to assess electrical isolation of the pulmonary veins and left atrial posterior wall

Conditions

Atrial Fibrillation; Surgery; Ablation of Atrial Fibrillation; Clamp Study

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CellFX nsPFA Treatment Arm

Adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box using the CellFX® nsPFA™ Cardiac Surgery System.

Group Type: EXPERIMENTAL

CellFX® nsPFA™ Cardiac Surgery System

Intervention Type: 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.

Interventions

CellFX® nsPFA™ Cardiac Surgery System

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.

Intervention Type: DEVICE

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 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
• 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

Exclusion Criteria

• 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
• Prior cardiac surgery (Redo)
• Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, Atrioventricular (AV) nodal reentry
• Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or atrial septal defect repair.
• Prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation)
• Class IV New York Heart Association (NYHA) heart failure symptoms
• Prior history of cerebrovascular accident or TIA within 6 months or at any time if there is residual neurological deficit
• Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment
• Need for emergent cardiac surgery (i.e., cardiogenic shock)
• 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
• A known drug and/or alcohol addiction
• Mental impairment or other conditions which 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
• History of abnormal bleeding and/or clotting disorder
• Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin)
• Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
• Body mass index > 40 kg/m2
• Use of any other investigational drug, therapy, or device within 30 days prior to enrollment or concurrent participation in another research study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avania

INDUSTRY

Sponsor Role: collaborator

Pulse Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rich Nuccitelli, PhD

Role: STUDY_DIRECTOR

Pulse Biosciences, Inc.

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Academic Medical Center

Amsterdam, , Netherlands

Site Status: ACTIVE_NOT_RECRUITING

Catharina Hospital

Eindhoven, , Netherlands

Site Status: RECRUITING

Maastricht University Medical Center+ (MUMC+)

Maastricht, , Netherlands

Site Status: ACTIVE_NOT_RECRUITING

St. Antonius Hospital

Nieuwegein, , Netherlands

Site Status: RECRUITING

State Medical Institute of the Ministry of Interior Affairs and Administration

Warsaw, , Poland

Site Status: RECRUITING

Countries

Austria; Netherlands; Poland

Central Contacts

William A. Knape

Role: CONTACT

bknape@pulsebiosciences.com

+1 (919) 757-2033

Aleksandra Kurek

Role: CONTACT

aleksandra.kurek@pulsebiosciences.com

+44 745 6655949

Facility Contacts

Prof. Marek Ehrlich, M.D., Ph.D

Role: primary

N.J. (Niels) Verberkmoes, MD

Role: primary

Prof. Dr. Piotr Suwalski, M.D. Ph.D

Role: primary

Other Identifiers

NCT06355063

Identifier Type: OTHER

Identifier Source: secondary_id

NP-PCF-037

Identifier Type: -

Identifier Source: org_study_id