Ventricular Catheter Ablation Study (VCAS)

NCT06203262 | Recruiting FDA Device

• 1 other identifier: FM-PFA-VT-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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).

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

Outcome Measures

Primary Outcomes (1)

• Safety Endpoint Acute

  device-related or procedure-related Serious Adverse Events

  < 30 days

Secondary Outcomes (5)

• Reduction in clinical arrhythmia burden (VCAS-I)

  baseline, 90 days & 180 days

• Reduction in clinical arrhythmia burden (VCAS-II)

  baseline, after 90 days and no longer than 120 days

• Procedure duration (average minutes of procedure time)

  1 day

• Evaluate VT inducibility (VCAS-I) pre and post ablation

  index procedure

• Detect Ischemic scar homogenization (VCAS-I)

  baseline and 90 days

Other Outcomes (2)

• Device Deficiencies

  180 days

• Adverse Events and Serious Adverse Events

  180 days

Study Arms (2)

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

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.

Device: FieldForce™ Ablation System Premature Ventricular Contractions

Interventions

FieldForce™ Ablation System Ventricular Tachycardia DEVICE

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.

Also known as: Pulse Field Ablation

Ventricular Tachycardia (VCAS-I)

FieldForce™ Ablation System Premature Ventricular Contractions DEVICE

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.

Also known as: Pulse Field Ablation

Premature Ventricular Contractions (VCAS-II)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Field Medical: lead

Study Sites (2)

Na Homolce Hospital

Prague, 150 00, Czechia

RECRUITING

IKEM

Prague, Czechia

RECRUITING

Related Publications (1)

• 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.

  PMID: 41071961 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Premature Complexes

Interventions

Irreversible Electroporation Therapy

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature

Intervention Hierarchy (Ancestors)

Electroporation Therapies; Therapeutics; Electroporation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Central Study Contacts

Steven R Mickelsen, MD

CONTACT

319 333-8236; mickelsen@fieldmedicalinc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 12, 2024
• Study Start: April 12, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CZ (2)