The Field PULSE Study

NCT ID: NCT06452589

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2026-06-30

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.

Detailed Description

Atrial fibrillation (AF) is a cardiac rhythm disorder characterized by irregular and often abnormally fast contractions of the atrial cardiomyocytes resulting in various symptoms, including palpitations, dizziness, shortness of breath and tiredness.

AF is the most common sustained cardiac arrhythmia, having a prevalence of about ≈2% in the general population. AF can be associated with increased morbidity and mortality in patients with cardiovascular disease, and increased risk of stroke in general population.

Catheter ablation for the treatment of AF is primarily performed with radiofrequency (RF) or cryoballoon (CB) catheters to achieve anatomic pulmonary vein isolation (PVI). However, the technical challenges of achieving effective PVI and recognized risks of complications are two most important factors driving the need for replacing thermal ablation technologies like RF and CB.

Pulsed field ablation (PFA) is a non-thermal ablation technology which uses high voltage pulsed electrical fields to ablate tissues. This destabilizes cell membranes by forming irreversible nanoscale pores and leakage of cell contents, culminating in cell death. Several clinical studies have demonstrated that PFA can achieve pulmonary vein isolation with minimal collateral damage in a time-efficient manner.

The FieldForce™ Ablation System utilizes PFA with an innovative electrode technology called FieldBending™ designed to improve safety, tolerability, and efficacy for focal deflectable catheters used for the treatment of AF.

Conditions

Atrial Arrhythmias

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Catheter ablation

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

Group Type: EXPERIMENTAL

FieldForce Ablation System

Intervention Type: 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.

Interventions

FieldForce Ablation System

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.

Intervention Type: DEVICE

Other Intervention Names

Pulse Field Ablation

Eligibility Criteria

Inclusion Criteria

1. Signed patient informed consent form (ICF).

2. Female and male patients aged ≥ 18 and ≤ 80.

3. Documented atrial fibrillation via an electrocardiogram (must be at least 30 seconds) within one year of enrollment.

4. Indicated for a first-time catheter ablation for atrial fibrillation or associated atrial arrhythmias (European guidelines).

Exclusion Criteria

1. Body Mass Index > 40.

2. Ineligible for ablation (including but not limited to known left atrial thrombus).

3. AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible/non-cardiac causes.

4. Previous endocardial/epicardial ablation or surgery for AF.

5. NYHA Class IV.

6. Left atrial appendage device or occlusion within 180 days.

7. Atrial or ventricular septal defect closure.

8. Atrial myxoma.

9. The presence of inferior vena cava embolic protection filter devices.

10. Significant or symptomatic untreated hypotension, bradycardia, or chronotropic incompetence.

11. History of hemodynamically severe valvular disease. Severity should be assessed using echocardiography, according to AHA and European guidelines.

12. Diagnosis of pacemaker dependance.

13. Uncontrolled abnormal bleeding and/or clotting disorder.

14. Contraindication to systemic or oral anticoagulation.

15. 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.

16. History of severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea which may interfere with the assessment of the therapy.

17. Active malignancy.

18. Uncontrolled clinically significant infection.

19. Life expectancy is less than one year.

20. Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the study requirements.

21. Any of the following within 3 months of enrollment: myocardial infarction, unstable angina, percutaneous coronary intervention, heart surgery (coronary artery bypass grafting/atriotomy), stroke or transient ischemic attack (TIA);

22. Participation in another investigational study that would interfere with this study.

23. Patient is not able to understand the nature of this study or is unwilling or unable to attend the study procedures.

24. Women who are of childbearing age and not on a reliable form of birth control.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Field Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Na Homolce Hospital

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Steven R Mickelsen, MD

Role: CONTACT

mickelsen@fieldmedicalinc.com

319 333-8236

Facility Contacts

Stepan Kralovec

Role: primary

Other Identifiers

CLN-PULSE-PR-01

Identifier Type: -

Identifier Source: org_study_id