Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA

Not Applicable

Recruiting

• Conditions: Focal Ventricular Arrhythmias; Premature Ventricular Contractions; Ventricular Tachycardias

• Registration Number: NCT06747013
• Lead Sponsor: Vivek Reddy

Brief Summary

The purpose of this study is to examine the use of a point ablation catheter (Farapoint, Boston Scientific) in the mapping and ablation of focal ventricular arrhythmias (premature ventricular contractions or ventricular tachycardia) using pulsed field energy.

Detailed Description

Study Design - This is a prospective, single-center, single-arm clinical pilot study to assess the safety and effectiveness of ablation of focal ventricular arrhythmias using the Farapoint catheter.

Sample Size - A total of 30 subjects will be included in this study. All patients will undergo treatment with the study PFA catheter.

Study Population - The target population is subjects who are planned to undergo a clinically-indicated ablation procedure for managing their focal ventricular arrhythmias - premature ventricular contractions or ventricular tachycardias.

Study Duration - Approximately 12 months: 3 months site start-up, 6 months enrollment and 3 months of follow up.

Participant Duration - Subjects will undergo brief pre-procedural testing, the ablation procedure, and 3 months of post-procedural follow up.

Primary Effectiveness Endpoint Chronic Single-Procedure Success: defined as a reduction in the burden of premature ventricular contracts (\>80%) for patients treated for PVCs or absence of sustained focal ventricular tachycardia for patients being treated for focal VTs without an increase in anti-arrhythmic medications at 3 month follow ups.

Study Timeline

• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Study First Posted: 2024-12-24
• Study Start: 2025-01-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Subjects must meet ALL of the following inclusion criteria to be eligible for participation in this clinical investigation:

• Patient is planned for a catheter ablation procedure to ablate either:

  • Premature ventricular contractions (PVCs) and a class I or IIa indication for catheter ablation of PVCS according to the 2019 HRS/EHRA/APHRS/LAHRS guidelines
  • Symptomatic Sustained Monomorphic Ventricular Tachycardia

• Able and willing to provide written consent and comply with all testing and follow-up requirements

• Above 18 years of age

Exclusion Criteria

• Documented intracardiac thrombus or (if this can be dissolved with anticoagulation, the patient would then be eligible to participate)
• Contraindication to anticoagulation
• Life expectancy or other disease processes likely to limit survival to less than 12 months.
• Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
• NYHA Class IV heart failure
• Severe, untreated coronary artery disease which would preclude infusion of provocative agents
• Severe aortic stenosis (AVA < 1.0cm, or PG > 64mmHg)
• Severe mitral regurgitation.
• Allergy to contrast which is unable to be adequately pre-medicated.
• Acute non-cardiovascular illness or systemic infection
• Thrombocytopenia (platelet count < 50,000/mm3) or coagulopathy unless corrected
• Cardiogenic shock unrelated to ventricular arrhythmias
• Pregnancy or anticipated pregnancy during study follow-up
• PVCs or VT, which are felt to be secondary to electrolyte imbalances active thyroid disease or any reversible non-cardiac cause.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Freedom from PVC/VT recurrence	at 3 months following ablation procedure	Freedom from PVC/VT recurrence defined as a reduction in the burden of premature ventricular contracts (\>80%) for patients treated for PVCs or absence of sustained focal ventricular tachycardia for patients being treated for focal VTs without an increase in anti-arrhythmic medications at 3 month follow ups.; (Sustained Focal Tachycardia is defined as that persisting for \> 30 seconds or ventricular tachycardia which is sufficient to result in hemodynamic effect (i.e. hypotension or syncope))

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse events	at 3 months following ablation procedure	Safety is measured as incidence of Serious Adverse Device Effects (SADEs)
Incidence of Serious Adverse Events (SAEs)	at 3 months following ablation procedure	Safety is measured as incidence of Serious Adverse Events (SAEs)
Incidence of non-serious adverse events	at 3 months following ablation procedure	Safety is measured as incidence of non-serious adverse events

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States