Clinical trial NCT06355063: CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
Official title: Initial Safety and Performance of the CellFX® nsPFA™ Cardiac Surgery System for the Treatment of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Surgery
Keywords: CellFX
nsPFA Cardiac Surgery System
Lead sponsor: Pulse Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-09
Enrollment: 30
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: This study is a prospective, multicenter, single arm, non-randomized, feasibility study.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Rate of acute major adverse events (MAEs)
timeFrame: Within 30 days post-ablation procedure
measure: Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial box
timeFrame: Within 24 hours post-ablation procedure
Secondary outcomes:
measure: Proportion of Participants with one or more SAEs
timeFrame: Up to 12-months post-procedure
measure: Number of Participants with Long-Term Technical Success
timeFrame: 60-120 days following the index procedure
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+ (MUMC+)
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
affiliation: Pulse Biosciences, Inc.
name: Rich Nuccitelli, PhD
role: STUDY_DIRECTOR
References: