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Not yet recruitingNCT07794215Updated Oct 15, 2026

Pivotal Study to Evaluate Catheter Ablation in Patients With Scar-Related Monomorphic Sustained VT in the Ventricular Ectopy and Reduction in Tachycardia Ablation Studies Program VERITAS SCAR VT

An interventional study of System is an investigational catheter-based device designed to deliver pulsed field ablation energy to cardiac tissue for the treatment of sustained monomorphic VT in Scar-related Monomorphic Sustained VT, sponsored by Field Medical. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Field Medical · Not applicable, Interventional, and Treatment

Updated Oct 15, 2026Title changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The VERITAS VT Study is a prospective, multicenter, international, single-arm clinical investigation designed to evaluate the safety and effectiveness of the FieldForce™ Pulsed Field Ablation System for the treatment of sustained monomorphic ventricular tachycardia (VT). Eligible patients undergoing catheter ablation for VT will receive treatment with the investigational pulsed field ablation system according to the study protocol.

The study will assess acute and chronic outcomes including major adverse events, freedom from recurrent ventricular tachycardia, need for antiarrhythmic drug escalation, repeat ablation procedures, and other clinically relevant outcomes through 180 days following the index ablation procedure.

Read the detailed description

Ventricular tachycardia remains a significant source of morbidity and mortality among patients with structural heart disease. Although catheter ablation is an established therapeutic option, long-term recurrence rates remain substantial and procedural challenges continue to exist.

The VERITAS VT Study is a prospective, multicenter, single-arm clinical investigation evaluating the safety and effectiveness of the Field Force Pulsed Field Ablation System in subjects with sustained monomorphic ventricular tachycardia. Eligible participants will undergo mapping and ablation using the Field Force Pulsed Field Ablation System during the index procedure. Subjects will be followed for 180 days after the index procedure to assess safety and effectiveness outcomes.

The primary safety objective is to evaluate the incidence of device- and procedure-related major adverse events. The primary effectiveness objective is to evaluate freedom from recurrence of sustained monomorphic ventricular tachycardia through 180 days following the index ablation procedure

02

Conditions studied

  • Scar-related Monomorphic Sustained VT

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Keywords

  • Pulsed Field Ablation for Ventricular Tachycardia
  • Cardiac ablation of VT
  • Ischemic cardiomyopathy
  • Non-Ischemic cardiomyopathy
03

In context

Cicatrix

611 studies on the registry are indexed under Cicatrix; 114 are open to participants now.

This study's planned enrollment of 180 is above the median of 40 across 512 interventional studies indexed under Cicatrix.

Browse Cicatrix studies →

Lead sponsor

Field Medical is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed patient 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
    • to, 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. (LVEF) ≥ 20% confirmed by echocardiography or comparable imaging techniques within 180 days prior to enrollment or during baseline evaluation.

Exclusion criteria

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. (NYHA) Class IV heart failure.
  13. Uncontrolled abnormal bleeding and/or clotting disorder.
  14. 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. ≥ 40.
  20. Chronic renal insufficiency of estimated (eGFR) \< 30 mL/min/1.73 m2.
  21. Active .
  22. Active systemic infection.
  23. is less than one year.
  24. Prohibitively distorted cardiac anatomy due to congenital heart disease.
  25. Participation in another 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 who is not on a reliable form of .
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Field Force Pulsed Fiel Ablation

    Participants will undergo ventricular tachycardia ablation using the Field Force Pulsed Field Ablation System during the index procedure.

    Device: System is an investigational catheter-based device designed to deliver pulsed field ablation energy to cardiac tissue for the treatment of sustained monomorphic VT

Interventions

  • DeviceSystem is an investigational catheter-based device designed to deliver pulsed field ablation energy to cardiac tissue for the treatment of sustained monomorphic VT

    The Field Force Pulsed Field Ablation System is an investigational device that delivers non-thermal pulsed electric field energy through a catheter-based platform to ablate targeted cardiac tissue. The system is intended for use during catheter ablation procedures in patients with sustained monomorphic ventricular tachycardia (VT) to treat tissue involved in the initiation and maintenance of the arrhythmia.

06

What researchers measure

Primary outcomes

  1. Primary Safety Endpoint - Freedom from casual or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure. (Or within 90 days for esophageal events (fistula/perforation)

    A pre-defined list of device - or procedure-related MAEs, as adjudicated by the Clinical Events Committee (CEC), occurring within 7 days after the index ablation procedure (or within 3 months after the index ablation procedure for any esophago-pericardial fistula/esophageal perforation) will be considered a primary safety event

    Time frame: As applicable within 7 days or 90 days after the index ablation procedure

  2. Primary Effectiveness: Freedom from recurrence of sustained monomorphic VT

    Freedom from recurrence of sustained monomorphic VT (MMVT) in the absence of new or increased dose of Class I or III antiarrhythmic drugs (AAD) for any ventricular arrhythmia through 6 months after the index ablation procedure

    Time frame: Through 6 months most the index ablation procedure

Secondary outcomes

  1. Secondary Effectiveness Endpoint: Percentage of patients with reduced ventricular tachycardia burden

    Percentage of patients with reduced ventricular tachycardia burden

    Time frame: 6 months post index procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Title
This Study Will Evaluate if the Field Force Pulsed Field Ablation System is Safe and Effective for Treating Sustained Monomorphic Ventricular Tachycardia, a Potentially Serious Fast Heart Rhythm of the Heart. The Treatment Uses Short Pulses of Energy to Target and Destroy the Heart Tissue Causing VT→Pivotal Study to Evaluate Catheter Ablation in Patients With Scar-Related Monomorphic Sustained VT in the Ventricular Ectopy and Reduction in Tachycardia Ablation Studies Program VERITAS SCAR VT
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Title This Study Will Evaluate if the Field Force Pulsed Field Ablation System is Safe and Effective for Treating Sustained Monomorphic Ventricular Tachycardia, a Potentially Serious Fast Heart Rhythm of the Heart. The Treatment Uses Short Pulses of Energy to Target and Destroy the Heart Tissue Causing VT→Pivotal Study to Evaluate Catheter Ablation in Patients With Scar-Related Monomorphic Sustained VT in the Ventricular Ectopy and Reduction in Tachycardia Ablation Studies Program VERITAS SCAR VT
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07794215
Lead sponsor
Field Medical
Collaborators
Duke Clinical Research Institute, MedNet Solutions
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Dec 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Oct 15, 2026

Study contacts

Philippa Hill
Contact
hill@fieldmedicalinc.com
+1 (909)-287-9659
Vivek Reddy, MD
principal investigator · MOUNT SINAI HOSPITAL

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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