No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
135 (estimated)
Sponsor
Pulse Biosciences, Inc. · Industry
Who this trial is looking for
This trial is looking for people between 18 and 85 years old who have atrial fibrillation and are scheduled for heart surgery. Participants will undergo a procedure using the Pulse Biosciences system during their surgery and attend follow-up visits.
Are You a Good Fit for This Trial?
Rules you outWolff-Parkinson-White syndromeSignificant liver dysfunctionSevere peripheral arterial diseaseKnown drug and/or alcohol addictionSevere Chronic Obstructive Pulmonary Disease
You may be able to join if
I am between 18 and 85 years old.
I can provide consent for the study procedures.
I have documented intermittent or persistent atrial fibrillation within the last year.
I am scheduled for a non-emergency heart surgery.
My heart strength (ejection fraction) is 30% or higher.
I expect to live at least 5 more years.
I live close enough to the trial site and will remain in the area for 12 months.
You may not be able to join if
I have an implantable electronic medical device.
I have a history of a blood clot in the left atrium.
I have a prosthetic heart valve.
I have had heart surgery before.
I have a left atrial diameter greater than 6cm.
I have had a stroke in the last 6 months.
I have severe heart failure symptoms.
I am currently pregnant or planning to become pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
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 include the potential for surgical AF ablation, and completion of follow-up visits as specified in the clinical study protocol
* Subj…
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 include the potential for surgical AF ablation, and completion of follow-up visits as specified in the clinical study protocol
* 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 sustains for \> 7 days and requires intervention) within one year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor or telemetry strip from the study hospital or an outside physician
* 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 replacement, Aortic valve repair or replacement, Ascending aortic aneurysms, Atrial Septal Defect (ASD)/Patent Foramen Ovale (PFO) 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
* Subject currently lives within a reasonable commuting distance of the investigational site and plans to remain geographically stable through 12 month follow up
Exclusion Criteria:
* 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
* Subjects 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)
* Subjects 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 hepatic failure)
* 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
* 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
* 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
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