Randomized Controlled Trial of Pulse Biosciences' CellFX® Nanosecond Pulsed Field Ablation Cardiac Surgery Clamp System for Treatment of Atrial Fibrillation During Concomitant Cardiac Surgery Compared to a Control Arm Not Receiving Ablation

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Adventist Heart Institute: Adventist Health St. Helena
RECRUITING
St. Helena
Michigan
Cardiac Surgery Clinic | Frankel Cardiovascular Center
RECRUITING
Ann Arbor
Contact Information
Primary
Shweta Kalpa, MD
Shweta.Kalpa@pulsebiosciences.com
(800) 543-3695
Backup
William A. Knape
bknape@pulsebiosciences.com
(919) 757-2033
Time Frame
Start Date: 2025-10-23
Estimated Completion Date: 2028-12
Participants
Target number of participants: 135
Treatments
Experimental: CellFX nsPFA Clamp
Adult subjects who are eligible to participate will undergo a concomitant cardiac surgical procedure with nsPFA ablation (of left and right pulmonary veins as well as roof and floor lesions to form a box) and treatment of left atrial appendage.
Related Therapeutic Areas
Sponsors
Leads: Pulse Biosciences, Inc.
Collaborators: Avania

This content was sourced from clinicaltrials.gov