CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Initial Safety and Performance of the CellFX® nsPFA™ Cardiac Surgery System for the Treatment of Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06355063
• Other study ID #: NP-PCF-037
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: April 2024
• Source: Pulse Biosciences, Inc.
• Contact: William A. Knape
• Phone: +1 (919) 757-2033
• Email: bknape[@]pulsebiosciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subject must be between 22 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Surgery

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	St. Antonius Hospital	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
Pulse Biosciences, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of acute major adverse events (MAEs)	Acute major adverse events (MAEs) include, cardiac death, stroke, myocardial infarction, transient ischemic attack, or excessive bleeding.	Within 30 days post-ablation procedure
Primary	Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial free wall.	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.	Within 24 hours post-ablation procedure
Secondary	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.	Up to 12-months post-procedure
Secondary	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 by cardiac electroanatomical mapping 2-6 months post-ablation procedure.	60-120 days following the index procedure