Scar-related Monomorphic Sustained VTNCT07794215
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
A study testing 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 people with Scar-related Monomorphic Sustained VT, run by Field Medical.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Scar-related Monomorphic Sustained VT
- What is being tested?
- System is an investigational catheter-based device designed to deliver pulsed field ablation energy to cardiac tissue for the treatment of sustained monomorphic VT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed patient informed consent form (ICF).
- Female and male patients aged ≥ 18 and ≤ 85 years.
- Implantable Cardioverter-Defibrillator (ICD) implanted ≥ 180 days prior to enrollment.
- 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)
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- 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)
- Left ventricular ejection fraction (LVEF) ≥ 20% confirmed by echocardiography or comparable imaging techniques within 180 days prior to enrollment or during baseline evaluation.
Who cannot join
- Subjects will be excluded if ANY of the following apply:
- VT secondary to reversible causes (e.g. electrolyte abnormalities, drug or alcohol-induced arrhythmia or non-cardiac cause).
- VT ablation within 14 days prior to enrollment.
- Greater than three (3) VT ablations within one (1) year prior to enrollment.
- Ventricular fibrillation (VF), polymorphic VT or Torsades de Pointes (TdP) as primary clinical arrhythmia.
- Bundle branch reentry (BBR), Idiopathic, Para-Hisian or Fascicular VT.
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- 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
- Acute myocardial infarction ≤ 90 days prior to enrollment.
- 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.
- Implanted with a ventricular assist device (VAD).
- Severe mitral or aortic regurgitation or stenosis evaluated by echo or comparable technique.
- Presence of an aortic or mitral mechanical valve.
- New York Heart Association (NYHA) Class IV heart failure.
- Uncontrolled abnormal bleeding and/or clotting disorder.
- Contraindication to systemic or oral anticoagulation.
- 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).
- Ineligible for ablation according to physician judgement (including but not limited to hemodynamically unstable, prior interatrial patch, Amplatzer, etc.).
- 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.
- Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea at the time of enrollment.
- Body Mass Index ≥ 40.
- Chronic renal insufficiency of estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
- Active malignancy.
- Active systemic infection.
- Life expectancy is less than one year.
- Prohibitively distorted cardiac anatomy due to congenital heart disease.
- Participation in another investigational study that may interfere with the procedure outcomes for this study unless pre-approved by sponsor.
- Unable to understand the nature of this study or is unwilling or unable to attend all the study visits.
- Pregnancy or planned pregnancy, lactating or any women of childbearing potential who is not on a reliable form of birth control.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)
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
- Conditions
- Scar-related Monomorphic Sustained VT
- Being tested
- System is an investigational catheter-based device designed to deliver pulsed field ablation energy to cardiac tissue for the treatment of sustained monomorphic VT
- Keywords
- Pulsed Field Ablation for Ventricular Tachycardia, Cardiac ablation of VT, Ischemic cardiomyopathy, Non-Ischemic cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
System is an investigational catheter-based device designed to deliver pulsed field ablation energy to cardiac tissue for the treatment of sustained monomorphic VTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Field Force Pulsed Fiel Ablation | Experimental | Participants will undergo ventricular tachycardia ablation using the Field Force Pulsed Field Ablation System during the index procedure. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: As applicable within 7 days or 90 days after the index ablation procedure
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
Measured: 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
Measured: 6 months post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar-related Monomorphic Sustained VTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Field Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute, MedNet Solutions
- Responsible party
- Sponsor
- Investigators
- Vivek Reddy, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794215
- Sponsor's protocol ID
- CLN-00011
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07794215
- Acronym / sponsor ID
- CLN-00011
- Conditions
- Scar-related Monomorphic Sustained VT
- Keywords
- Pulsed Field Ablation for Ventricular Tachycardia, Cardiac ablation of VT, Ischemic cardiomyopathy, Non-Ischemic cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Field MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute, MedNet Solutions
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Field Force Pulsed Fiel Ablation | Experimental | Device: System is an investigational catheter-based device designed to deliver pulsed field ablation energy to cardiac tissue for the treatment of sustained monomorphic VTParticipants will undergo ventricular tachycardia ablation using the Field Force Pulsed Field Ablation System during the index procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed patient informed consent form (ICF).
- Female and male patients aged ≥ 18 and ≤ 85 years.
- Implantable Cardioverter-Defibrillator (ICD) implanted ≥ 180 days prior to enrollment.
- Clinically Indicated for ventricular tachycardia (VT) ablation by 2019 guidelines:
- Sustained scar-related monomorphic ventricular tachycardia (MMVT):
Key exclusion criteria (34 listed)
- VT secondary to reversible causes (e.g. electrolyte abnormalities, drug or alcohol-induced arrhythmia or non-cardiac cause).
- VT ablation within 14 days prior to enrollment.
- Greater than three (3) VT ablations within one (1) year prior to enrollment.
- Ventricular fibrillation (VF), polymorphic VT or Torsades de Pointes (TdP) as primary clinical arrhythmia.
- Bundle branch reentry (BBR), Idiopathic, Para-Hisian or Fascicular VT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| System is an investigational catheter-based device designed to deliver pulsed field ablation energy to cardiac tissue for the treatment of sustained monomorphic VTThe 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. | Device | Field Force Pulsed Fiel Ablation |
Primary outcome
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)
Time frame: As applicable within 7 days or 90 days after the index ablation procedure
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
Primary Effectiveness: Freedom from recurrence of sustained monomorphic VT
Time frame: Through 6 months most the index ablation procedure
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
1 secondary outcome
Secondary Effectiveness Endpoint: Percentage of patients with reduced ventricular tachycardia burden
Time frame: 6 months post index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Scar-related Monomorphic Sustained VT
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vivek Reddy, MD principal investigator
MOUNT SINAI HOSPITAL
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Scar-related Monomorphic Sustained VT, run by Field Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippa Hill (+1 (909)-287-9659, hill@fieldmedicalinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: As applicable within 7 days or 90 days after the index ablation procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.