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

Part of paid clinical trials in St. Helena, California.

Sponsor
Pulse Biosciences, Inc.
Study ID
NCT06959121
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • CellFX® nsPFA™ Cardiac Surgery System — DEVICE
    Participants will receive cardiac ablation with the CellFX® nsPFA™ Cardiac Clamp

Study Details

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.

Key Dates

Start date
Oct 23, 2025
Status verified
Jan 2026
Primary completion
Apr 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
135 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Freedom from atrial fibrillation/atrial flutter/atrial tachycardia [ Time Frame: 3-months through 6 months post-index procedure ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Adventist Heart Institute: Adventist Health St. HelenaSt. HelenaCalifornia94574
Aaron M Kime, MD
707-963-7200
Cardiac Surgery Clinic | Frankel Cardiovascular CenterAnn ArborMichigan48109
Matthew A Romano, MD
888-287-1082

Find similar trials in St. Helena, CA

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Adventist Heart Institute: Adventist Health St. Helena· St. Helena, CACardiac Surgery Clinic | Frankel Cardiovascular Center· Ann Arbor, MI

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