Ann Arbor, MINCT06959121Now EnrollingIRB Ready

Atrial Fibrillation Clinical Trial in Ann Arbor, MI

Access cutting-edge atrial fibrillation treatment through this clinical trial at a research site in Ann Arbor. Study-provided care at no cost to qualified participants.

Sponsored by Pulse Biosciences, Inc.

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Expert Care in Ann Arbor

Access atrial fibrillation specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related atrial fibrillation treatment provided free

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Check if you qualify for this atrial fibrillation clinical trial in Ann Arbor, MI

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Ann Arbor

    Convenient for MI residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Ann Arbor site if eligible
  4. 4Begin participation

About This Atrial Fibrillation Study in Ann Arbor

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.

Sponsor: Pulse Biosciences, Inc.

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Ann Arbor?

Yes, this clinical trial (NCT06959121) has an active research site in Ann Arbor, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Atrial Fibrillation Treatment Options in Ann Arbor, MI

If you're searching for atrial fibrillation treatment options in Ann Arbor, MI, this clinical trial (NCT06959121) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Ann Arbor research site is actively enrolling participants for this clinical trial. You'll receive care from experienced atrial fibrillation specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all atrial fibrillation clinical trials near you to find additional studies recruiting in your area.

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