The Field PULSE Study

NCT06452589 | Recruiting FDA Device

• 1 other identifier: CLN-PULSE-PR-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pre-market, first-in-human, pilot, interventional, clinical investigation that aims to evaluate safety and feasibility of the FieldForce™ Ablation system in patients with atrial fibrillation who are indicated for an AF catheter ablation.

Conditions

Atrial Arrhythmias

Keywords

atrial arrhythmia; atrial fibrillation; PFA; Pulse Field Ablation

Outcome Measures

Primary Outcomes (2)

• Incidence of early and late onset adverse events

  Adverse events to evaluate the safety of the FieldForce™ Ablation System will be collected. The incidence of the major safety events will be evaluated.

  30 days and 12 months

• Performance

  To characterize the proportion of subjects who achieved pulmonary vein isolation (PVI) using the FieldForce™ Ablation System

  index procedure and 3 months

Secondary Outcomes (3)

• Device or Procedure Related SAEs

  30 days, 3 months, 6 months and 12 months

• Presence of Atrial Arrhythmias from index procedure through end of study

  6 months and 12 months

• Procedure Time

  Index procedure

Study Arms (1)

Catheter ablation

EXPERIMENTAL

Adult patients with a history of atrial fibrillation or associated atrial arrhythmias and indicated for a catheter ablation.

Device: FieldForce Ablation System

Interventions

FieldForce Ablation System DEVICE

The FieldForce Ablation System is indicated for cardiac electrophysiologic mapping, delivery of diagnostic pacing stimuli, and pulse field ablation of cardiac tissue. When used with the FieldForce Ablation Catheter, the FieldForce System is intended to be used in the right/left atria and/or left/right ventricle to deliver PFA ablation lesions in the selected areas of the chamber.

Also known as: Pulse Field Ablation

Catheter ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed patient informed consent form (ICF).
• Female and male patients aged ≥ 18 and ≤ 80.
• Documented atrial fibrillation via an electrocardiogram (must be at least 30 seconds) within one year of enrollment.
• Indicated for a first-time catheter ablation for atrial fibrillation or associated atrial arrhythmias (European guidelines).

You may not qualify if:

• Body Mass Index \> 40.
• Ineligible for ablation (including but not limited to known left atrial thrombus).
• AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible/non-cardiac causes.
• Previous endocardial/epicardial ablation or surgery for AF.
• NYHA Class IV.
• Left atrial appendage device or occlusion within 180 days.
• Atrial or ventricular septal defect closure.
• Atrial myxoma.
• The presence of inferior vena cava embolic protection filter devices.
• Significant or symptomatic untreated hypotension, bradycardia, or chronotropic incompetence.
• History of hemodynamically severe valvular disease. Severity should be assessed using echocardiography, according to AHA and European guidelines.
• Diagnosis of pacemaker dependance.
• Uncontrolled abnormal bleeding and/or clotting disorder.
• Contraindication to systemic or oral anticoagulation.
• Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment of therapy, or confound data or its interpretation, including but not limited to solid organ or hematologic transplant, or currently being evaluated for an organ transplant.

Sponsors & Collaborators

• Field Medical: lead

Study Sites (1)

Na Homolce Hospital

Prague, 150 00, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Irreversible Electroporation Therapy

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electroporation Therapies; Therapeutics; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Central Study Contacts

Steven R Mickelsen, MD

CONTACT

319 333-8236; mickelsen@fieldmedicalinc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective single arm safety and feasibility study.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CZ (1)