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CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation

NCT06355063 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-12

No results posted yet for this study

Summary

This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure.

Conditions

Interventions

DEVICE

CellFX® nsPFA™ Cardiac Surgery System

Adult patients presenting to the investigational center that are to undergo non-emergent concomitant cardiac surgical procedure(s), scheduled to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, ascending aortic aneurysms, or coronary artery bypass procedures with history of documented atrial fibrillation within one year prior to enrollment will be evaluated for eligibility and participation in the study.

Sponsors & Collaborators

  • Pulse Biosciences, Inc.

    lead INDUSTRY

  • Avania

    collaborator INDUSTRY

Principal Investigators

  • Rich Nuccitelli, PhD · Pulse Biosciences, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • Austria
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06355063 on ClinicalTrials.gov