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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ventricular Tachycardias; Premature Ventricular Contractions; Focal Ventricular Arrhythmias
• Intervention / Treatment: Device: Point Ablation Catheter

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ablation using study catheter; All patients will undergo a standard ablation protocol using the study catheter (Farapoint)	Device: Point Ablation Catheter; a point ablation catheter using a pulse field energy; Other Names: Farapoint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from PVC/VT recurrence	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))	at 3 months following ablation procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vivek Reddy
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Vivek Reddy, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Ventricular Arrhythmias; VT; PVCs; Premature Ventricular Contractions; Ventricular Tachycardias; Symptomatic Sustained Monomorphic Ventricular Tachycardia
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Cardiac Complexes, Premature; Tachycardia; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular; Ventricular Premature Complexes
• Other Study ID Numbers: STUDY-24-00971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: No