Ventricular TachyarrhythmiaVCASNCT06203262
Ventricular Catheter Ablation Study (VCAS)
A study testing FieldForce™ Ablation System Ventricular Tachycardia and FieldForce™ Ablation System Premature Ventricular Contractions in people with Ventricular Tachyarrhythmia and Ventricular Arrythmia, run by Field Medical at 2 sites in Czechia.
Trial summary
This is a prospective safety and feasibility study to evaluate the safety of the FieldForce™ Ablation system in patients with ventricular arrhythmia divided into two groups: VT (VCAS-I) and frequent premature ventricular complex (VCAS-II). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachyarrhythmia, Ventricular Arrythmia, PVC - Premature Ventricular Complex
- What is being tested?
- FieldForce™ Ablation System Ventricular Tachycardia and FieldForce™ Ablation System Premature Ventricular Contractions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesCzechia
- Study dates
- 12 Apr 2024to 28 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed patient informed consent form (ICF).
- Female and male participants between 18 and 80 years.
- 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
- For VCAS-II group, patients with frequent premature ventricular complexes (PVCs) meeting class II-a/b indications based on European guidelines for catheter ablation.
- 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.
Who cannot join
- Body Mass Index > 40.
- Pacemaker dependence.
- 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).
- Recent MI (less than 90 days) or another reversible cause of VT (e.g., electrolyte abnormalities, drug-induced arrhythmia).
- The presence of inferior vena cava embolic protection filter devices.
- Recent cardiac surgery (less than 2 months)
Show all 22Show fewer
- NYHA Class IV.
- Hemodynamically severe valvular disease that precludes ablation. Severity will be evaluated by using echocardiography, according to AHA and European guidelines.
- Uncontrolled abnormal bleeding and/or clotting disorder.
- Contraindication to systemic or oral anticoagulation.
- 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.
- Chronic renal insufficiency of eGFR< 30 mL/min/1.73 m2.
- Active malignancy
- Untreated clinically significant infection.
- Life expectancy is less than one year.
- Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the study requirements.
- Prohibitively distorted cardiac anatomy due to congenital heart disease.
- Had a recent percutaneous coronary intervention (<1 month).
- Participation in another investigational study or treatment with any investigational drug within the previous 30 days that would interfere with this study.
- Patient is not able to understand the nature of this study or is unwilling or unable to attend the study procedures.
- Pregnancy or breastfeeding
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate Safety and Feasibility of the FieldForce™ Ablation System in Symptomatic Patients With Ventricular Arrhythmia
This is a prospective safety and feasibility study to evaluate the safety of the FieldForce™ Ablation system in patients with ventricular arrhythmia divided into two groups: VT (VCAS-I) and frequent premature ventricular complex (VCAS-II).
Read the detailed description
Summary:
Ventricular arrythmias are common but often undertreated. The most effective pharmacologic management and implantable devices are used to treat deadly arrythmias like ventricular tachycardia (VT) and ventricular fibrillation (VF). However, the efficacy of antiarrhythmic drugs (AADs) has been proven to be low, and implantable cardioverter defibrillators (ICDs) treat VT but do not prevent it. Prospective trials demonstrate that VT ablation is by far the most effective therapy for ventricular tachycardia and in some cases it is curative. Despite overwhelming evidence that catheter ablation is superior, there are many technical barriers that prevent widespread application of this therapy. Furthermore, non-fatal ventricular arrythmias such as premature ventricular contractions (PVCs) are treatable by catheter ablation. The technical challenges facing VT and PVC ablations are similar as current technologies are optimized to treat atrial arrythmias often at the expense of performance in the ventricle.
Pulsed field ablation (PFA) is a new ablation method for the therapy of arrhythmias. PFA is considered as a non-thermal and low-energy method of ablation. This technique is characterized by pulse trains of short-duration and high-voltage electrical impulses that result in electric field-mediated tissue injury. The very strong electric fields put strain on cellular compartmentalization. These changes can be reversible, and cells can recover with no consequences; however, if compartmentalization is disrupted for an extended period of time, it results in metabolic injury and cell death. This mechanism is also known as electroporation. Different cell types are sensitive to these types of insults leading to tissue selectivity in the heart. Clinical studies have already demonstrated the feasibility and safety of PFA for the treatment of atrial fibrillation. However, there is less data on the application of PFA for VT.
Therefore, this Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation aims to evaluate Safety and Feasibility of the FieldForce™ Ablation system in patients with ventricular tachycardia divided into two groups: ventricular tachycardia (VCAS-I) and unifocal premature ventricular complex (VCAS-II).
- Conditions
- Ventricular Tachyarrhythmia, Ventricular Arrythmia, PVC - Premature Ventricular Complex, PVC - Premature Ventricular Contraction, Ventricular Tachycardia
- Being tested
- FieldForce™ Ablation System Ventricular Tachycardia, FieldForce™ Ablation System Premature Ventricular Contractions
- Keywords
- ventricular tachycardia, VT, premature ventricular contractions, PVC, electroporation, pulse field ablation, PFA
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FieldForce™ Ablation System Ventricular TachycardiaDevice
Also called Pulse Field Ablation
Catheter ablation is a minimally invasive procedure. The physician advances multiple catheters into the heart that are used to diagnose and localize abnormal cardiac tissue involved in the initiation and maintenance of ventricular tachycardia and/or PVCs. Once the abnormal tissue is identified a specialized catheter is advanced to the target and energy is applied to destroy the abnormal tissue. The intervention will be identical to the conventional procedure except that an investigational ablation catheter will be used to deliver energy.
FieldForce™ Ablation System Premature Ventricular ContractionsDevice
Also called Pulse Field Ablation
Catheter ablation is a minimally invasive procedure. The physician advances multiple catheters into the heart that are used to diagnose and localize abnormal cardiac tissue involved in the initiation and maintenance of ventricular tachycardia and/or PVCs. Once the abnormal tissue is identified a specialized catheter is advanced to the target and energy is applied to destroy the abnormal tissue. The intervention will be identical to the conventional procedure except that an investigational ablation catheter will be used to deliver energy.
| Study group | Role | What they receive |
|---|---|---|
| Ventricular Tachycardia (VCAS-I) | Experimental | Patients with ventricular tachycardia meeting class II-a/b indications in European guideline for catheter ablation, with a clinical VT event detected by an implanted ICD Receives: Device: FieldForce™ Ablation System Ventricular Tachycardia |
| Premature Ventricular Contractions (VCAS-II) | Experimental | For VCAS-II group, patients with symptomatic frequent unifocal premature ventricular complexes (PVCs) meeting class II-a/b indications based on European guidelines for catheter ablation. 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. Receives: Device: FieldForce™ Ablation System Premature Ventricular Contractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint Acute
device-related or procedure-related Serious Adverse Events
Measured: < 30 days
Secondary outcomes (5)
Reduction in clinical arrhythmia burden (VCAS-I)
Compare the baseline arrhythmia logs recorded on the ICD to post procedure arrhythmia logs
Measured: baseline, 90 days & 180 days
Reduction in clinical arrhythmia burden (VCAS-II)
Compare the baseline 24-hour Holter PVC burden after ablation
Measured: baseline, after 90 days and no longer than 120 days
Procedure duration (average minutes of procedure time)
Time points in the procedure will be recorded and stratified by group
Measured: 1 day
Evaluate VT inducibility (VCAS-I) pre and post ablation
VT inducibility using programed stimulation using two drive cycle lengths and triple extra stimuli will be performed.
Measured: index procedure
Detect Ischemic scar homogenization (VCAS-I)
Ischemic scar homogenization using cardiac magnetic resonance (CMR) will be performed before ablation at baseline and 90 days.
Measured: baseline and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start12 Apr 2024
- Primary completion31 Oct 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachyarrhythmiaStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Prospective single arm safety and feasibility study. There are two populations that will be enrolled and analyzed separately: patients being treated for ventricular tachycardia (VCAS-I) and patients with frequent premature ventricular contractions (VCAS-II). The intervention in both cases is similar.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Field Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203262
- Sponsor's protocol ID
- FM-PFA-VT-2023
- Acronym
- VCAS
- Status last verified
- May 2026
- First submitted
- 30 Dec 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Reddy VY, Koruth JS, Peichl P, Petru J, Funasako M, Skoda J, Watanabe K, Nies M, Kautzner J, Neuzil P. High-Voltage Focal Pulsed Field Ablation to Treat Scar-Related Ventricular Tachycardia: The First-in-Human VCAS Trial. Circulation. 2025 Dec 16;152(24):1691-1704. doi: 10.1161/CIRCULATIONAHA.125.077025. Epub 2025 Oct 10.
PubMed 41071961
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate Safety and Feasibility of the FieldForce™ Ablation System in Symptomatic Patients With Ventricular Arrhythmia
- ClinicalTrials.gov ID
- NCT06203262
- Acronym / sponsor ID
- VCAS / FM-PFA-VT-2023
- Conditions
- Ventricular Tachyarrhythmia, Ventricular Arrythmia, PVC - Premature Ventricular Complex, PVC - Premature Ventricular Contraction, Ventricular Tachycardia
- Keywords
- ventricular tachycardia, VT, premature ventricular contractions, PVC, electroporation, pulse field ablation, PFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Field MedicalIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 12 Jan 2024 (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.
This is a prospective safety and feasibility study to evaluate the safety of the FieldForce™ Ablation system in patients with ventricular arrhythmia divided into two groups: VT (VCAS-I) and frequent premature ventricular complex (VCAS-II).
Detailed description
Summary:
Ventricular arrythmias are common but often undertreated. The most effective pharmacologic management and implantable devices are used to treat deadly arrythmias like ventricular tachycardia (VT) and ventricular fibrillation (VF). However, the efficacy of antiarrhythmic drugs (AADs) has been proven to be low, and implantable cardioverter defibrillators (ICDs) treat VT but do not prevent it. Prospective trials demonstrate that VT ablation is by far the most effective therapy for ventricular tachycardia and in some cases it is curative. Despite overwhelming evidence that catheter ablation is superior, there are many technical barriers that prevent widespread application of this therapy. Furthermore, non-fatal ventricular arrythmias such as premature ventricular contractions (PVCs) are treatable by catheter ablation. The technical challenges facing VT and PVC ablations are similar as current technologies are optimized to treat atrial arrythmias often at the expense of performance in the ventricle.
Pulsed field ablation (PFA) is a new ablation method for the therapy of arrhythmias. PFA is considered as a non-thermal and low-energy method of ablation. This technique is characterized by pulse trains of short-duration and high-voltage electrical impulses that result in electric field-mediated tissue injury. The very strong electric fields put strain on cellular compartmentalization. These changes can be reversible, and cells can recover with no consequences; however, if compartmentalization is disrupted for an extended period of time, it results in metabolic injury and cell death. This mechanism is also known as electroporation. Different cell types are sensitive to these types of insults leading to tissue selectivity in the heart. Clinical studies have already demonstrated the feasibility and safety of PFA for the treatment of atrial fibrillation. However, there is less data on the application of PFA for VT.
Therefore, this Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation aims to evaluate Safety and Feasibility of the FieldForce™ Ablation system in patients with ventricular tachycardia divided into two groups: ventricular tachycardia (VCAS-I) and unifocal premature ventricular complex (VCAS-II).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective single arm safety and feasibility study. There are two populations that will be enrolled and analyzed separately: patients being treated for ventricular tachycardia (VCAS-I) and patients with frequent premature ventricular contractions (VCAS-II). The intervention in both cases is similar.
| Arm | Type | Receives |
|---|---|---|
| Ventricular Tachycardia (VCAS-I) | Experimental | Device: FieldForce™ Ablation System Ventricular TachycardiaPatients with ventricular tachycardia meeting class II-a/b indications in European guideline for catheter ablation, with a clinical VT event detected by an implanted ICD |
| Premature Ventricular Contractions (VCAS-II) | Experimental | Device: FieldForce™ Ablation System Premature Ventricular ContractionsFor VCAS-II group, patients with symptomatic frequent unifocal premature ventricular complexes (PVCs) meeting class II-a/b indications based on European guidelines for catheter ablation. 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed patient informed consent form (ICF).
- Female and male participants between 18 and 80 years.
- 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
- For VCAS-II group, patients with frequent premature ventricular complexes (PVCs) meeting class II-a/b indications based on European guidelines for catheter ablation.
- 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.
Key exclusion criteria (22 listed)
- Body Mass Index > 40.
- Pacemaker dependence.
- 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).
- Recent MI (less than 90 days) or another reversible cause of VT (e.g., electrolyte abnormalities, drug-induced arrhythmia).
- The presence of inferior vena cava embolic protection filter devices.
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 |
|---|---|---|
| FieldForce™ Ablation System Ventricular TachycardiaAlso: Pulse Field AblationCatheter ablation is a minimally invasive procedure. The physician advances multiple catheters into the heart that are used to diagnose and localize abnormal cardiac tissue involved in the initiation and maintenance of ventricular tachycardia and/or PVCs. Once the abnormal tissue is identified a specialized catheter is advanced to the target and energy is applied to destroy the abnormal tissue. The intervention will be identical to the conventional procedure except that an investigational ablation catheter will be used to deliver energy. | Device | Ventricular Tachycardia (VCAS-I) |
| FieldForce™ Ablation System Premature Ventricular ContractionsAlso: Pulse Field AblationCatheter ablation is a minimally invasive procedure. The physician advances multiple catheters into the heart that are used to diagnose and localize abnormal cardiac tissue involved in the initiation and maintenance of ventricular tachycardia and/or PVCs. Once the abnormal tissue is identified a specialized catheter is advanced to the target and energy is applied to destroy the abnormal tissue. The intervention will be identical to the conventional procedure except that an investigational ablation catheter will be used to deliver energy. | Device | Premature Ventricular Contractions (VCAS-II) |
Primary outcome
Safety Endpoint Acute
Time frame: < 30 days
device-related or procedure-related Serious Adverse Events
5 secondary outcomes
Reduction in clinical arrhythmia burden (VCAS-I)
Time frame: baseline, 90 days & 180 days
Reduction in clinical arrhythmia burden (VCAS-II)
Time frame: baseline, after 90 days and no longer than 120 days
Procedure duration (average minutes of procedure time)
Time frame: 1 day
Evaluate VT inducibility (VCAS-I) pre and post ablation
Time frame: index procedure
Detect Ischemic scar homogenization (VCAS-I)
Time frame: baseline and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 41071961Reddy VY, Koruth JS, Peichl P, Petru J, Funasako M, Skoda J, Watanabe K, Nies M, Kautzner J, Neuzil P. High-Voltage Focal Pulsed Field Ablation to Treat Scar-Related Ventricular Tachycardia: The First-in-Human VCAS Trial. Circulation. 2025 Dec 16;152(24):1691-1704. doi: 10.1161/CIRCULATIONAHA.125.077025. Epub 2025 Oct 10.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FieldForce™ Ablation System Ventricular Tachycardia and FieldForce™ Ablation System Premature Ventricular Contractions in people with Ventricular Tachyarrhythmia and Ventricular Arrythmia, run by Field Medical at 2 sites in Czechia.
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 5 inclusion and 22 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: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint Acute (time frame: < 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06203262, which also lists 1 linked publication.
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 14 May 2026.