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New treatment option for Atrial Fibrillation
Official title CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation
ClinicalTrials.gov ID: NCT06959121
What this study is testing
- What it's testing
- The primary objective of this Pivotal study is to demonstrate the safety and effectiveness of the Pulse Biosciences nsPFA™ Cardiac Surgery System in treating atrial fibrillation during concomitant cardiac surgical procedures.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Subject must be between 18 and 85 years of age
- Subject is willing and capable of providing Informed Consent to undergo study procedures which include the potential for surgical AF ablation, and...
- Subject has history of documented paroxysmal atrial fibrillation (AF that is intermittent and terminates within ≤ 7 days of onset) or...
- Subject is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery via...
- Left ventricular ejection fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as...
You likely can't join if
- Subject has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter-defibrillator (ICD), or Cardiac Resynchronization...
- Subject has history or known to have LAA clot
- Subject has a prosthetic heart valve
- Stand- alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
- Prior cardiac surgery including prior cardiac surgical ablation
- Left Atrial diameter ≥ 6cm
See the full eligibility 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 include the potential for surgical AF ablation, and completion of follow-up visits as specified in the clinical study...
- Subject has history of documented paroxysmal atrial fibrillation (AF that is intermittent and terminates within ≤ 7 days of onset) or persistent/longstanding persistent atrial fibrillation (AF that is continuous and...
- Subject is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery via sternotomy for one or more of the following: Mitral valve repair or...
- 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
- Subject currently lives within a reasonable commuting distance of the investigational site and plans to remain geographically stable through 12 month follow up
- Subject has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter-defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) or left atrial appendage (LAA) device
- Subject has history or known to have LAA clot
- Subject has a prosthetic heart valve
- Stand- alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
- Prior cardiac surgery including prior cardiac surgical ablation
- Left Atrial diameter ≥ 6cm
- Wolff-Parkinson-White syndrome or other Supra-Ventricular Arrhythmia, Atrioventricular (AV) nodal reentry
- Documented history of persistent or long standing persistent atrial fibrillation longer than 10 years
- people requiring surgery other than CABG and/or cardiac valve surgery and/or atrial septal defect repair/PFO and ascending aorta
- Prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation)
- people that are on an AAD for ventricular arrhythmia.
- STS Predicted Risk of Mortality (STS PROM) of 10 or higher
- Class III or IV New York Heart Association (NYHA) heart failure symptoms
- Prior history of stroke within 6 months
- Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment
- Need for emergent cardiac surgery (per sit-to-stand (STS) test definition)
- 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 (significant liver dysfunction with markedly significant elevation of liver enzymes, such as cirrhosis with decompensation, portal hypertension, or a history of...
- A known drug and/or alcohol addiction
- Mental impairment or other conditions that 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
- people who have been treated with thoracic radiation
- people in current chemotherapy
- people on long-term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases)
- people with known hypertrophic obstructive cardiomyopathy
- people with known cold agglutinin
- Subject has a contraindication to anticoagulation (e.g., a bleeding or clotting disorder such as Idiopathic Thrombocytopenic Purpura (ITP))
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- Body mass index \> 45 kg/m2
- Any diagnosed connective tissue disorder
- Severe Chronic Obstructive Pulmonary Disease (COPD) per sit-to-stand (STS) test definition
- Use of any other investigational drug, therapy, or device within 30 days before enrollment or concurrent participation in another research study
The study team makes the final eligibility decision.
Where it's taking place
- St. Helena, California, United States
- Ann Arbor, Michigan, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St. Helena, California, United States; Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.