Can a new ablation technique quiet dangerous heart rhythms?
NCT ID NCT07794215
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 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 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Scar-related monomorphic sustained VT are added.
By submitting, you agree to our Terms of use
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.