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: Not yet recruiting
• Conditions: Ventricular Tachycardia; Ventricular Arrythmia; Ventricular Tachyarrhythmia; PVC - Premature Ventricular Complex; PVC - Premature Ventricular Contraction
• Intervention / Treatment: Device: Catheter Ablation Ventricular Tachicardia; Device: Catheter Ablation 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.

The European Heart Rhythm Association (EHRA), Heart Rhythm Society (HRS), and Asia Pacific Heart Rhythm Society (APHRS) Expert Consensus on Ventricular Arrhythmias recommends catheter ablation for symptomatic ventricular arrythmias both lethal and non-lethal such as PVCs refractory to medical management. First-line therapy for patients with VT/VF or severely impaired systolic function at risk of sudden death, consists of implantable cardioverter defibrillator (ICD) and/or antiarrhythmic drug therapy. However, ICDs do not prevent recurrent VT episodes, which may result in device tachy therapy including shocks. Antiarrhythmic drugs can be effective in preventing recurrent VT in a minority of patients reducing appropriate ICD shocks but are associated with significant long-term side effects and organ toxicities. Catheter ablation is an accepted first-line therapy for idiopathic VT which makes up a minority of clinical cases. Likewise, first line therapy for PVCs is pharmacologic. However, studies have shown that catheter ablation is 70.2% more effective (based on 1 year recurrence rate of 19.4% in RF ablation group versus 88.6% in antiarrhythmic therapy group) for treatment of PVCs.

Minimally invasive catheter-based procedures are currently considered the most effective therapy available for VT but there are significant barriers to widespread application [8]. The challenges come from some practical considerations. The traditional approach for VT ablation implies the recognition of the origin and/or propagation of the myocardial signal during arrhythmia which is normally investigated through mappings done using an intracardiac mapping catheter.

Catheter ablation is normally used with or without ICD implantation as a secondary prevention when AADs are either ineffective or not desirable. The recurrence rates of Ventricular Tachycardia (VT) RF ablation can vary widely and are about 12-47%. The authors point out factors that contribute to RF ablation treatment failure and the risk of high recurrence rates including inadequate lesion size and inability to create a transmural lesion in the ventricles. Strategies such as bipolar RF ablation have been studied where two separate catheters are positioned to deliver the energy between them that can increase the treatment depth. Even though bipolar ablation in the ventricles has shown the possibility of creating larger lesions compared to unipolar ablation, still it does not guarantee transmurality. The average transmurality using unipolar and bipolar RF in the ventricular tissue is 11% and 54%.

Steam cavitation effect, which is also called steam pop, is a major complication that can lead to cardiac tamponade and/or VT. Based on the same review paper, steam pop occurred in 26% and 6% of the RF ablation procedures using unipolar and bipolar settings respectively.

There are two main factors that contribute to the challenges facing RF ablation in the ventricle: first being the physics of thermodynamics and second being mechanical design of the delivery systems. Heat transfer physics are recognized to be extremely complex and difficult to predict in a beating heart. In order to achieve good lesions with RF ablation catheter stability and contact force are required. The complex anatomic geometry of the ventricle, which is deeply trabeculated, interferes with our ability to ablate tissue that is not a part of the compact ventricle myocardium leaving bridges of functional muscle intact over the target site. Stability is incredibly difficult to achieve since some parts of the ventricle move more than a centimeter during each cardiac cycle, furthermore the blood flow in the chamber works to cool the muscle counteracting effective heat transfer.

The design considerations for catheter ablation are influenced by anatomic constraints. In order to perform catheter ablation almost all tools use femoral vascular access. Given that 90% of all catheter ablations procedures are done in the atria, it is no surprise that handling characteristics of these tools have been optimized to deliver therapy in the atria. Therefore, the current tools do not perform well in the ventricles interfering with our ability to deliver the ablation energy effectively. Although the mechanical challenges of the delivery system can be overcome, there has not been a lot of incentive to build tools specifically for ventricular arrythmias.

In summary, these factors might explain why the ventricular RF ablation procedures are time consuming (3 to 7 hours). Despite the need for ablations in numerous patients, limited physicians can overcome the challenges of RF ablation in the ventricles which limits the number of total ablations done universally.

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.

In this context, the FieldForce™ Ablation system utilizes an innovative electrode technology, designed to reduce the total ablation time, improved tolerability, minimize the transferred energy by about 20-25 times compared to RF, increase safety, eliminate the chance of steam pop and increase efficacy for focal deflectable catheters used for the treatment of ventricular arrythmias.

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 (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Steven R Mickelsen, MD; Phone Number: 319 333-8236; Email: mickelsen@fieldmedicalinc.com

Study Locations

• Czechia
  • Prague, Czechia, 150 00
    • Holmoice Hospital
    • Principal Investigator: Petr Neuzil, MD
    • Contact: stepan Kralovec

Participation Criteria

Eligibility Criteria

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

Description

INCLUSION:

• 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 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 >11% PVC burden for asymptomatic patients and >5% PVC burden for symptomatic patients within the last 60 days.

EXCLUSION:

• 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< 60 mL/min/1.73 m2, any history of renal dialysis, or history of renal transplant.
• 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

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 Tachicardia (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: Catheter Ablation Ventricular Tachicardia; Catheter ablation is s 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 >11% PVC burden for asymptomatic patients and >5% PVC burden for symptomatic patients within the last 60 days.	Device: Catheter Ablation Premature Ventricular Contractions; Catheter ablation is s 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	Sevice-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 hotter PVC burden after ablation	baseline, 90 days & 180 days
Procedure duration (average minutes of procedure time)	Time points in the procedure will be recorded and compared to historic controlls	1 day
Change in Quality of life	Six month QOL will be compared to baseline using SF-12 QOL questionnaire	baseline and 180 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac events related to clinical arrhythmia	Reoccurrence of clinical ventricular arrhythmia requiring hospitalization, intervention or change in medical therapy.	180 days
Major clinical events	Occurrences related to hospitalization, unscheduled clinic visits, and/or death	180 days

Collaborators and Investigators

• Sponsor: Field Medical

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 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): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: ventricular tachycardia; VT; electroporation; PFA; PVC; pulse field ablation; premature ventricular contractions
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Cardiac Complexes, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes
• Other Study ID Numbers: FM001

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