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

NCT06959121 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

CellFX® nsPFA™ Cardiac Surgery System

Participants will receive cardiac ablation with the CellFX® nsPFA™ Cardiac Clamp

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Pulse Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Matthew A. Romano, MD · University of Michigan, Cardiac Surgery Clinic | Frankel Cardiovascular Center

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
2025-10-23
Primary Completion
2027-04-30
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

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 NCT06959121 on ClinicalTrials.gov