NCT06355063 CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
| NCT ID | NCT06355063 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pulse Biosciences, Inc. |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-07-31 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Rich Nuccitelli, PhD
STUDY DIRECTOR
Pulse Biosciences, Inc.
Frequently Asked Questions
Who can join the NCT06355063 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06355063 currently recruiting?
Yes, NCT06355063 is actively recruiting participants. Contact the research team at bknape@pulsebiosciences.com for enrollment information.
Where is the NCT06355063 trial being conducted?
This trial is being conducted at Vienna, Austria, Amsterdam, Netherlands, Eindhoven, Netherlands, Maastricht, Netherlands and 2 additional locations.
Who is sponsoring the NCT06355063 clinical trial?
NCT06355063 is sponsored by Pulse Biosciences, Inc.. The principal investigator is Rich Nuccitelli, PhD at Pulse Biosciences, Inc.. The trial plans to enroll 30 participants.
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