Atrial FibrillationSurgeryAblation of Atrial FibrillationClamp Study
Investigational drug(s) / intervention(s)
CellFX® nsPFA™ Cardiac Surgery System
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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 outcome measure(s)
Rate of acute major adverse events (MAEs) — Within 30 days post-ablation procedure Acute major adverse events (MAEs) include, cardiac death, stroke, myocardial infarction, transient ischemic attack, or excessive bleeding.
Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial box — Within 24 hours post-ablation procedure 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.
Trial sites (6)
Facility
City
Region
Status
Medical University of Vienna
Vienna
Austria
Recruiting
Academic Medical Center
Amsterdam
Netherlands
Active Not Recruiting
Catharina Hospital
Eindhoven
Netherlands
Recruiting
Maastricht University Medical Center+ (MUMC+)
Maastricht
Netherlands
Active Not Recruiting
St. Antonius Hospital
Nieuwegein
Netherlands
Recruiting
State Medical Institute of the Ministry of Interior Affairs and Administration
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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