Ventricular Catheter Ablation Study (VCAS) (VCAS)

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).

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia; Ventricular Arrythmia; Ventricular Tachyarrhythmia; PVC - Premature Ventricular Complex; PVC - Premature Ventricular Contraction
• Intervention / Treatment: Device: FieldForce™ Ablation System Ventricular Tachycardia; Device: FieldForce™ Ablation System Premature Ventricular Contractions

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • IKEM
  • Prague, Czechia, 150 00
    • Na Homolce Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION:

1. Signed patient informed consent form (ICF).
2. Female and male participants between 18 and 80 years.
3. 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
4. For VCAS-II group, patients with frequent premature ventricular complexes (PVCs) meeting class II-a/b indications based on European guidelines for catheter ablation.
5. 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.

EXCLUSION:

1. Body Mass Index > 40.
2. Pacemaker dependence.
3. 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).
4. Recent MI (less than 90 days) or another reversible cause of VT (e.g., electrolyte abnormalities, drug-induced arrhythmia).
5. The presence of inferior vena cava embolic protection filter devices.
6. Recent cardiac surgery (less than 2 months)
7. NYHA Class IV.
8. Hemodynamically severe valvular disease that precludes ablation. Severity will be evaluated by using echocardiography, according to AHA and European guidelines.
9. Uncontrolled abnormal bleeding and/or clotting disorder.
10. Contraindication to systemic or oral anticoagulation.
11. 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.
12. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea.
13. Chronic renal insufficiency of eGFR< 30 mL/min/1.73 m2.
14. Active malignancy
15. Untreated clinically significant infection.
16. Life expectancy is less than one year.
17. Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the study requirements.
18. Prohibitively distorted cardiac anatomy due to congenital heart disease.
19. Had a recent percutaneous coronary intervention (<1 month).
20. Participation in another investigational study or treatment with any investigational drug within the previous 30 days that would interfere with this study.
21. Patient is not able to understand the nature of this study or is unwilling or unable to attend the study procedures.
22. Pregnancy or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventricular Tachycardia (VCAS-I); 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	Device: FieldForce™ Ablation System Ventricular Tachycardia; 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.; Other Names: Pulse Field Ablation
Experimental: Premature Ventricular Contractions (VCAS-II); 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.	Device: FieldForce™ Ablation System Premature Ventricular Contractions; 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.; Other Names: Pulse Field Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint Acute	device-related or procedure-related Serious Adverse Events	< 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in clinical arrhythmia burden (VCAS-I)	Compare the baseline arrhythmia logs recorded on the ICD to post procedure arrhythmia logs	baseline, 90 days & 180 days
Reduction in clinical arrhythmia burden (VCAS-II)	Compare the baseline 24-hour Holter PVC burden after ablation	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	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.	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.	baseline and 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Deficiencies	Device deficiencies/incidents before, during and after the use of the device.	180 days
Adverse Events and Serious Adverse Events	Adverse events and serious adverse events unrelated to study device or procedure over the duration of the study.	180 days

Collaborators and Investigators

• Sponsor: Field Medical

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): November 28, 2025

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ventricular tachycardia; VT; electroporation; PFA; PVC; pulse field ablation; premature ventricular contractions
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Cardiac Complexes, Premature; Tachycardia; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular; Ventricular Premature Complexes; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Cytological Techniques; Electrochemical Techniques; Electroporation Therapies; Electroporation; Irreversible Electroporation Therapy
• Other Study ID Numbers: FM-PFA-VT-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes