nsPFA Cardiac Surgery for Atrial Fibrillation

CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation

Recruiting N/A Interventional Study
Atrial Fibrillation Maze Procedure AF Ablation
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 out Wolff-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.

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About This Trial

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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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…
Contacts

Shweta Kalpa, MD

(800) 543-3695

Shweta.Kalpa@pulsebiosciences.com

CONTACT