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New heart device targets dangerous rhythms in first human test

NCT ID NCT06203262

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

34 people

The number who actually took part.

Started

Apr 2024

Finished

Nov 2025

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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

  • IKEM

    Prague, Czechia

  • Na Homolce Hospital

    Prague, 150 00, Czechia

More trials for these conditions

Other studies related to the condition(s) this trial covers.