Using CellFX technology to treat atrial fibrillation during cardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study aims to evaluate the safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the pulmonary veins during cardiac surgery. It is a prospective, multicenter, single-arm, non-randomized study involving adult patients who are scheduled for concomitant cardiac surgical procedures. Participants will undergo specific ablation procedures and will return for follow-up assessments to evaluate the electrical isolation of the targeted areas. The study seeks to provide insights into the potential benefits of this innovative technology in managing atrial fibrillation.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical University of Vienna
  Vienna, Austria Recruiting
• Catharina Hospital
  Eindhoven, Netherlands Recruiting
• St. Antonius Hospital
  Nieuwegein, Netherlands Recruiting
• State Medical Institute of the Ministry of Interior Affairs and Administration
  Warsaw, Poland Recruiting
• Academic Medical Center
  Amsterdam, Netherlands Active not recruiting
• Maastricht University Medical Center+ (MUMC+)
  Maastricht, Netherlands Active not recruiting

Study contacts

• Study coordinator: William A. Knape
• Email: bknape@pulsebiosciences.com
• Phone: +1 (919) 757-2033

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.