Ablation treatment for ventricular arrhythmias using the FieldForce™ system

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

This study is testing a new treatment using the FieldForce™ system to see if it can safely help people with ventricular arrhythmias, like ventricular tachycardia and frequent PVCs, feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Field Medical (industry)
• Locations: 2 sites (Prague and 1 other locations)
• Trial ID: NCT06203262 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and feasibility of the FieldForce™ Ablation system in treating patients with ventricular arrhythmias, specifically focusing on two groups: those with ventricular tachycardia (VT) and those with frequent premature ventricular complexes (PVCs). The study aims to address the limitations of current treatments, such as antiarrhythmic drugs and implantable cardioverter defibrillators, by utilizing pulsed field ablation, a novel non-thermal method that uses high-voltage electrical impulses to target arrhythmias. Participants will be monitored for safety and efficacy, with the goal of improving treatment outcomes for these conditions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with documented ventricular tachycardia or frequent premature ventricular complexes who meet specific clinical guidelines for catheter ablation.

Not a fit: Patients who are pacemaker dependent, have a body mass index over 40, or are deemed ineligible for ablation by their physician may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and safer treatment option for patients suffering from ventricular arrhythmias.

How similar studies have performed: While catheter ablation has shown success in treating arrhythmias, the specific use of pulsed field ablation is a novel approach that has not been extensively tested in this context.

Eligibility criteria

INCLUSION:

1. Signed patient informed consent form (ICF).
2. Female and male participants between 18 and 80 years.
3. For VCAS-I group, patients with VT meeting class II-a/b indications in European guideline for catheter ablation, with a clinical VT event detected by an implanted ICD
4. For VCAS-II group, patients with frequent premature ventricular complexes (PVCs) meeting class II-a/b indications based on European guidelines for catheter ablation.
5. For VCAS-II, documentation of frequent PVCs by 24 hours Holter with \>15% PVC burden for asymptomatic patients and \>5% PVC burden for symptomatic patients within the last 60 days.

EXCLUSION:

1. Body Mass Index \> 40.
2. Pacemaker dependence.
3. Ineligible for ablation according to Physician judgement (including but not limited to known to have protruding left ventricular thrombus or have implanted mechanical aortic and mitral valves).
4. Recent MI (less than 90 days) or another reversible cause of VT (e.g., electrolyte abnormalities, drug-induced arrhythmia).
5. The presence of inferior vena cava embolic protection filter devices.
6. Recent cardiac surgery (less than 2 months)
7. NYHA Class IV.
8. Hemodynamically severe valvular disease that precludes ablation. Severity will be evaluated by using echocardiography, according to AHA and European guidelines.
9. Uncontrolled abnormal bleeding and/or clotting disorder.
10. Contraindication to systemic or oral anticoagulation.
11. Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or 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.
12. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea.
13. Chronic renal insufficiency of eGFR\< 30 mL/min/1.73 m2.
14. Active malignancy
15. Untreated clinically significant infection.
16. Life expectancy is less than one year.
17. Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the study requirements.
18. Prohibitively distorted cardiac anatomy due to congenital heart disease.
19. Had a recent percutaneous coronary intervention (\<1 month).
20. Participation in another investigational study or treatment with any investigational drug within the previous 30 days that would interfere with this study.
21. Patient is not able to understand the nature of this study or is unwilling or unable to attend the study procedures.
22. Pregnancy or breastfeeding

Where this trial is running

Prague and 1 other locations

• Na Homolce Hospital — Prague, Czechia (RECRUITING)
• IKEM — Prague, Czechia (RECRUITING)

Study contacts

• Study coordinator: Steven R Mickelsen, MD

Conditions: Ventricular Tachyarrhythmia, Ventricular Arrythmia, PVC - Premature Ventricular Complex, PVC - Premature Ventricular Contraction, Ventricular Tachycardia, ventricular tachycardia, VT, premature ventricular contractions