Atrial Fibrillation Trial, Recruiting NCT06355063 Sponsor: Pulse Biosciences, Inc. Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT06355063
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People between 18 and 85 years of age
  • People who are willing and able to give informed consent and attend all required follow-up visits
  • People who have a confirmed diagnosis of atrial fibrillation (an irregular heart rhythm) within the past year, supported by a heart tracing or monitoring record
  • People who are already scheduled for planned (non-emergency) open-heart surgery using a heart-lung bypass machine, for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, repair of an enlarged section of the main artery from the heart, or coronary artery bypass surgery
  • People whose heart pumping strength is at least 30%, as measured by a heart scan or procedure done within the past 60 days
  • People with a life expectancy of at least 5 years

Who may not be able to join:

  • People who have an implanted electronic heart device (such as a pacemaker, defibrillator, or a device attached to the left side of the heart)
  • People who already have an artificial heart valve
  • People whose only heart condition is atrial fibrillation, with no separate need for bypass or valve surgery
  • People who have previously had a surgical Maze procedure (a specific heart rhythm operation)
  • People who have had previous heart surgery
  • People with certain other heart rhythm conditions, such as Wolff-Parkinson-White syndrome or related electrical pathway disorders
  • People who need surgery for reasons other than bypass, heart valve, or a hole-in-the-heart repair
  • People who have previously had a procedure involving instruments used inside the left chamber of the heart (such as a prior ablation)
  • People with the most severe category of heart failure symptoms (confirm with trial site)
  • People who have had a stroke or mini-stroke within the past 6 months, or at any time if lasting nerve or brain damage remains
  • People who have had a heart attack with a specific type of ECG change (ST-elevation) within the past 6 weeks
  • People who need emergency heart surgery
  • People with a known narrowing of the neck arteries greater than 80%
  • People with a currently active infection in the body
  • People with severe blockage of arteries in the limbs that causes pain with very little physical activity
  • People with kidney failure requiring dialysis, or serious liver failure
  • People with a known addiction to alcohol or drugs
  • People with a mental health condition or other reason that may prevent them from understanding what the study involves
  • People who are pregnant or who plan to become pregnant within 12 months of the study treatment
  • People who need heart-support devices or certain heart-strengthening medicines through a drip before surgery
  • People who have previously received radiation treatment to the chest area
  • People who are currently receiving chemotherapy
  • People on long-term steroid tablets or injections (not including occasional use of steroid inhalers for breathing conditions)
  • People with a known condition called hypertrophic obstructive cardiomyopathy (a thickening of the heart muscle that blocks blood flow)
  • People with a known condition called cold agglutinin (where the immune system reacts to cold temperatures in a way that affects the blood)
  • People with a history of abnormal bleeding or clotting problems
  • People who are unable to take blood-thinning medications such as heparin, dabigatran, apixaban, or warfarin
  • People who have had an organ or blood cell transplant, or who are currently being assessed for one
  • People with a body mass index (a measure of body weight relative to height) above 40
  • People who have taken part in another research study or used another experimental treatment or device within the past 30 days

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Rich Nuccitelli, PhD, Pulse Biosciences, Inc.

Phone: +1 (919) 757-2033

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Pulse Biosciences, Inc.
Registry
ClinicalTrials.gov
Start date
31 July 2024
Est. completion
31 December 2026

Where this trial is recruiting

🇦🇹 Austria 🇳🇱 Netherlands 🇵🇱 Poland

Primary endpoints

Rate of acute major adverse events (MAEs); Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial box

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov