New heart device targets dangerous rhythms in first human test
NCT ID NCT06203262
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tested a new device called the FieldForce™ Ablation System in 34 people with ventricular arrhythmias (dangerous heart rhythms). The device uses pulsed electric fields to destroy the small areas of heart tissue causing the problem. The main goal was to see if the procedure is safe and feasible, with a secondary focus on reducing the burden of arrhythmias.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FieldForce™ Ablation System (pulsed field ablation device)
- What this could lead to
- If successful, this could provide a new, safer way to destroy abnormal heart tissue causing dangerous heart rhythms, potentially reducing symptoms and improving quality of life.
- What could go wrong
- This is a very early, first-in-human study with only 34 people. The device may not work as well as existing methods, and there are risks from the procedure itself, such as bleeding or damage to the heart.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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34 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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IKEM
Prague, Czechia
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Na Homolce Hospital
Prague, 150 00, Czechia
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Other studies related to the condition(s) this trial covers.
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