Ventricular Catheter Ablation Study (VCAS)

Not Applicable

Recruiting

• Conditions: Ventricular Arrythmia; Ventricular Tachyarrhythmia; PVC - Premature Ventricular Complex; Ventricular Tachycardia; PVC - Premature Ventricular Contraction
• Interventions: Device: FieldForce™ Ablation System Ventricular Tachycardia; Device: FieldForce™ Ablation System Premature Ventricular Contractions

• Registration Number: NCT06203262
• Lead Sponsor: Field Medical

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).

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 Timeline

• Study First Submitted: 2023-12-30
• Study First Submitted QC: 2024-01-10
• Study First Posted: 2024-01-12
• Study Start: 2024-04-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-04-12
• Study Completion: 2025-04-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ventricular Tachycardia (VCAS-I)	FieldForce™ Ablation System Ventricular Tachycardia	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
Premature Ventricular Contractions (VCAS-II)	FieldForce™ Ablation System Premature Ventricular Contractions	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.

Primary Outcome Measures

Name	Time	Method
Safety Endpoint Acute	< 30 days	device-related or procedure-related Serious Adverse Events

Secondary Outcome Measures

Name	Time	Method
Procedure duration (average minutes of procedure time)	1 day	Time points in the procedure will be recorded and stratified by group
Detect Ischemic scar homogenization (VCAS-I)	baseline and 90 days	Ischemic scar homogenization using cardiac magnetic resonance (CMR) will be performed before ablation at baseline and 90 days.
Evaluate VT inducibility (VCAS-I) pre and post ablation	index procedure	VT inducibility using programed stimulation using two drive cycle lengths and triple extra stimuli will be performed.
Reduction in clinical arrhythmia burden (VCAS-I)	baseline, 90 days & 180 days	Compare the baseline arrhythmia logs recorded on the ICD to post procedure arrhythmia logs
Reduction in clinical arrhythmia burden (VCAS-II)	baseline, after 90 days and no longer than 120 days	Compare the baseline 24-hour Holter PVC burden after ablation

Trial Locations

Locations (2)

IKEM; 🇨🇿 Prague, Czechia

Na Homolce Hospital; 🇨🇿 Prague, Czechia