Ventricular Catheter Ablation Study (VCAS)

NCT ID: NCT06203262

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-12
• Study Completion Date: 2025-04-12

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).

Conditions

Ventricular Tachyarrhythmia; Ventricular Arrythmia; PVC - Premature Ventricular Complex; PVC - Premature Ventricular Contraction; Ventricular Tachycardia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

FieldForce™ Ablation System Ventricular Tachycardia

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

FieldForce™ Ablation System Premature Ventricular Contractions

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Pulse Field Ablation; Pulse Field Ablation

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Field Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Na Homolce Hospital

Prague, , Czechia

Site Status: RECRUITING

IKEM

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Steven R Mickelsen, MD

Role: CONTACT

mickelsen@fieldmedicalinc.com

319 333-8236

Facility Contacts

Stepan Kralovec

Role: primary

Stepan Kralovec

Role: primary

Other Identifiers

FM-PFA-VT-2023

Identifier Type: -

Identifier Source: org_study_id