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NCT06959121 · ClinicalTrials.gov registry record · NA

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

A NA study of Atrial Fibrillation and Ablation, sponsored by Pulse Biosciences.

Recruiting
Registry status
NA
Development phase
135
Enrollment target
2
Study locations

NCT06959121: Recruiting NA study of Atrial Fibrillation and Ablation, sponsored by Pulse Biosciences.

NCT06959121 is a NA study of Atrial Fibrillation and Ablation that is actively recruiting participants, run by Pulse Biosciences. The registered enrollment target is 135 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06959121, a NA study of Atrial Fibrillation and Ablation, is actively recruiting participants, sponsored by Pulse Biosciences.

RECRUITING
Registry status
NA
Development phase
135 participants
Enrollment target
2
Study locations

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.

Primary Outcome

Freedom from AF/AFL/AT of 30 seconds or greater duration and freedom for use of new or increased dose of previously failed Class I or III antiarrhythmic drugs (AADs) prescribed to treat atrial arrhythmias.

Interventions

  • DEVICE CellFX® nsPFA™ Cardiac Surgery System

Study Locations (2)

California

  • Adventist Heart Institute: Adventist Health St. Helena - St. Helena

Michigan

  • Cardiac Surgery Clinic | Frankel Cardiovascular Center - Ann Arbor

Trial Details

FieldValue
Enrollment Target 135 participants
Start Date 2025-10-23
Est. Completion 2028-12
Phase NA
Pulse Biosciences

10 total trials

What NCT06959121 shows while recruiting

NCT06959121 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (95% lower).

The record links to 4 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which CellFX® nsPFA™ Cardiac Surgery System is the first listed.

NCT06959121 reports a single indexed study location in California, Michigan.

Frequently Asked Questions

What is clinical trial NCT06959121 about?

NCT06959121 is a clinical study titled "CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation". 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.

What is the current status of trial NCT06959121?

This trial is currently recruiting. It is a NA study. The enrollment target is 135 participants. The study started on 2025-10-23. Estimated completion is 2028-12.

What conditions does trial NCT06959121 study?

This clinical trial studies the following conditions: Atrial Fibrillation, Ablation, Maze Procedure, AF.

What interventions are being tested in trial NCT06959121?

The interventions under investigation include: CellFX® nsPFA™ Cardiac Surgery System (DEVICE).

Who is sponsoring clinical trial NCT06959121?

This trial is sponsored by Pulse Biosciences, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06959121 being conducted?

This trial has 2 study locations across California, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Atrial Fibrillation

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06959121's enrollment target sits among peer trials

135 126th of 202 higher than 77 of 202 other Atrial Fibrillation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06959121, the US trial registry maintained by the National Library of Medicine. NCT06959121 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.