Initial Safety and Performance of the CellFX® nsPFA* Cardiac Surgery System for the Treatment of Atrial Fibrillatio

Recruiting

• Conditions: arrythmia; Atrial Fibrillation; 10007521

• Registration Number: NL-OMON56875
• Lead Sponsor: Pulse Biosciences, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Subject must be between 18 and 85 years of age
2. 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
3. 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
4. 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
5. Left ventricular ejection fraction >= 30% (determined by echocardiography or
cardiac catheterization performed within 60 days of enrollment as documented in
patient medical history)
6. Subject has a life expectancy of at least 5 years

Exclusion Criteria

1. Subject has an implantable electronic medical device. (i.e., pacemaker, ICD,
or CRT) or left atrial appendage device
2. Subject has a prosthetic heart valve
3. Stand- alone AF without indication(s) for concomitant Coronary Artery Bypass
Graft (CABG) and/or valve surgery
4. Previous surgical Maze procedure
5. Prior cardiac surgery (Redo)
6. Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia,
Atrioventricular (AV) nodal reentry
7. Subjects requiring surgery other than CABG and/or cardiac valve surgery
and/or atrial septal defect repair
8. Prior history of medical procedure involving instrumentation of the left
atrium (e.g., previous ablation)
9. Class IV New York Heart Association (NYHA) heart failure symptoms
10. Prior history of cerebrovascular accident or TIA within 6 months or at any
time if there is residual neurological deficit
11. Documented ST-segment elevation Myocardial Infarction (MI) within the 6
weeks prior to study enrollment
12. Need for emergent cardiac surgery (i.e., cardiogenic shock)
13. Known carotid artery stenosis greater than 80%
14. Current diagnosis of active systemic infection
15. Severe peripheral arterial occlusive disease defined as claudication with
minimal exertion
16. Renal failure requiring dialysis or hepatic failure
17. A known drug and/or alcohol addiction
18. Mental impairment or other conditions which may not allow the subject to
understand the nature, significance and scope of the study
19. Pregnancy or desire to get pregnant within 12-months of the study treatment
20. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
21. Subjects who have been treated with thoracic radiation
22. Subjects in current chemotherapy
23. Subjects on long term treatment with oral or injected steroids (not
including intermittent use of inhaled steroids for respiratory diseases)
24. Subjects with known hypertrophic obstructive cardiomyopathy
25. Subjects with known cold agglutinin
26. History of abnormal bleeding and/or clotting disorder
27. Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban,
Vitamin K Antagonists such as warfarin)
28. Solid organ or hematologic transplant, or currently being evaluated for an
organ transplant
29. Body mass index > 40 kg/m2
30. Use of any other investigational drug, therapy, or device within 30 days
prior to enrollment or concurrent participation in another research study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary safety endpoint is the rate of acute major adverse events (MAEs) which<br /><br>includes death, stroke, myocardial infarction (MI), and transient ischemic<br /><br>attack (TIA) or excessive bleeding (> 2units of blood and surgical<br /><br>intervention) within 30 days post-ablation procedure.<br /><br><br /><br>Primary effectiveness is acute electrical isolation of the bilateral pulmonary<br /><br>veins and left atrial Box by means of intraoperative entrance or exit block<br /><br>testing</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>• Subjects presenting with Primary SAEs up to the 12-month post-procedure<br /><br>follow-up<br /><br>• Subjects presenting with any AEs or SAEs up to the 12-month post-procedure<br /><br>follow-up<br /><br><br /><br>Effectiveness<br /><br>• Long-term technical success is defined as confirmation of electrical<br /><br>isolation of the bilateral pulmonary veins and left atrial Box by cardiac<br /><br>electroanatomical mapping at 60-120 days following the index procedure</p><br>