Evaluating a new ablation system for treating atrial fibrillation

A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate Safety and Feasibility of the FieldForce™ Ablation System in Patients With Atrial Fibrillation

This study is testing a new ablation system for people with atrial fibrillation to see if it can safely and effectively treat their condition using a different method that may cause less damage to surrounding tissues.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Field Medical (Industry-sponsored)
• Locations: 1 site (Prague)
• Trial ID: NCT06452589 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to assess the safety and feasibility of the FieldForce™ Ablation system in patients with atrial fibrillation who require catheter ablation. The study focuses on pulsed field ablation (PFA), a non-thermal technology that uses high voltage pulsed electrical fields to ablate cardiac tissues, potentially offering a safer and more effective alternative to traditional thermal ablation methods. Participants will undergo the procedure to determine the system's effectiveness in achieving pulmonary vein isolation while minimizing collateral damage. The study is designed as a first-in-human pilot investigation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with documented atrial fibrillation who are indicated for first-time catheter ablation.

Not a fit: Patients with a body mass index over 40 or those ineligible for ablation due to other medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with atrial fibrillation.

How similar studies have performed: Previous studies have shown promise for pulsed field ablation technologies, indicating potential for success in this novel approach.

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.

Where this trial is running

Prague

• Na Homolce Hospital — Prague, Czechia (Recruiting)

Study contacts

• Study coordinator: Steven R Mickelsen, MD

Conditions Atrial Arrhythmias; atrial arrhythmia; atrial fibrillation; PFA; Pulse Field Ablation