Can a new ablation technique quiet dangerous heart rhythms?

NCT ID NCT07794215

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests a catheter-based device that uses pulsed electric fields to ablate heart tissue causing ventricular tachycardia (VT), a fast and potentially dangerous heart rhythm. The study enrolls adults with scar-related VT who have an implantable defibrillator and are scheduled for ablation. Researchers will track safety and whether the procedure prevents VT recurrence for 180 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
The Field Force Pulsed Field Ablation System, a catheter-based device that delivers non-thermal pulsed electric fields to ablate targeted cardiac tissue
What this could lead to
If it works, this could offer a safer, more effective way to treat scar-related ventricular tachycardia, reducing the need for repeat procedures and antiarrhythmic drugs.
What could go wrong
This is a single-arm study, so there is no comparison group, and the results may not hold up in broader use. The procedure carries risks like any cardiac ablation, including major adverse events.

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

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

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 85 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 Criteria: 1. Signed patient informed consent form (ICF). 2. Female and male patients aged ≥ 18 and ≤ 85 years. 3. Implantable Cardioverter-Defibrillator (ICD) implanted ≥ 180 days prior to enrollment. 4. Clinically Indicated for ventricular tachycardia (VT) ablation by 2019 guidelines: * At least one (1) episode of VT, defined as continuous VT lasting \> 30 seconds or requiring termination due to hemodynamic compromise, detected by an implanted ICD ≤ 180 days prior to enrollment and * Refractory to, contraindicated or intolerant of at least one (1) Class I or III Antiarrhythmic Drug (AAD) 5. Sustained scar-related monomorphic ventricular tachycardia (MMVT): * Objective evidence of ventricular scar confirmed by imaging (magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET), intracardiac echocardiography/ transesophageal echocardiogram (ICE/TEE) and/or electro anatomical mapping (EAM)) Or * Prior myocardial infarction (MI) 6. Left ventricular ejection fraction (LVEF) ≥ 20% confirmed by echocardiography or comparable imaging techniques within 180 days prior to enrollment or during baseline evaluation. Exclusion Criteria: Subjects will be excluded if ANY of the following apply: 1. VT secondary to reversible causes (e.g. electrolyte abnormalities, drug or alcohol-induced arrhythmia or non-cardiac cause). 2. VT ablation within 14 days prior to enrollment. 3. Greater than three (3) VT ablations within one (1) year prior to enrollment. 4. Ventricular fibrillation (VF), polymorphic VT or Torsades de Pointes (TdP) as primary clinical arrhythmia. 5. Bundle branch reentry (BBR), Idiopathic, Para-Hisian or Fascicular VT. 6. For non-ischemic cardiomyopathy (NICM) if the following apply: * Active (within 120 days) inflammatory process (e.g. myocarditis) * Sarcoidosis * Hypertrophic cardiomyopathy (HCM) * Laminopathy (LMNA-related cardiomyopathy) * Brugada syndrome (BrS) * Amyloidosis 7. Acute myocardial infarction ≤ 90 days prior to enrollment. 8. Recent cardiac intervention ≤ 90 days prior to enrollment including but not limited to Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG), lead revision or upgrade, etc. 9. Implanted with a ventricular assist device (VAD). 10. Severe mitral or aortic regurgitation or stenosis evaluated by echo or comparable technique. 11. Presence of an aortic or mitral mechanical valve. 12. New York Heart Association (NYHA) Class IV heart failure. 13. Uncontrolled abnormal bleeding and/or clotting disorder. 14. Contraindication to systemic or oral anticoagulation. 15. Presence of active intracardiac thrombus detected by imaging (pre-procedural via transesophageal echocardiogram (TEE) or transthoracic echocardiogram (TTE), CT, MRI, or intra-procedural via intracardiac echocardiography (ICE). 16. Ineligible for ablation according to physician judgement (including but not limited to hemodynamically unstable, prior interatrial patch, Amplatzer, etc.). 17. 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. 18. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea at the time of enrollment. 19. Body Mass Index ≥ 40. 20. Chronic renal insufficiency of estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2. 21. Active malignancy. 22. Active systemic infection. 23. Life expectancy is less than one year. 24. Prohibitively distorted cardiac anatomy due to congenital heart disease. 25. Participation in another investigational study that may interfere with the procedure outcomes for this study unless pre-approved by sponsor. 26. Unable to understand the nature of this study or is unwilling or unable to attend all the study visits. 27. Pregnancy or planned pregnancy, lactating or any women of childbearing potential who is not on a reliable form of birth control.

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