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

NCT ID: NCT06747013

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-07
• Study Completion Date: 2026-12-31

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.

Conditions

Focal Ventricular Arrhythmias; Premature Ventricular Contractions; Ventricular Tachycardias

Study Design

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

Study Groups

Ablation using study catheter

All patients will undergo a standard ablation protocol using the study catheter (Farapoint)

Group Type: EXPERIMENTAL

Point Ablation Catheter

Intervention Type: DEVICE

a point ablation catheter using a pulse field energy

Interventions

Point Ablation Catheter

a point ablation catheter using a pulse field energy

Intervention Type: DEVICE

Other Intervention Names

Farapoint

Eligibility Criteria

Inclusion Criteria

• 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.

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

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Vivek Reddy

OTHER

Sponsor Role: lead

Responsible Party

Vivek Reddy

Director Arrhythmia Service MSHS

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vivek Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

STUDY-24-00971

Identifier Type: -

Identifier Source: org_study_id