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

Last updated: February 9, 2026
Sponsor: Vivek Reddy
Overall Status: Active - Enrolling

Phase

N/A

Condition

Circulation Disorders

Heart Disease

Heart Defect

Treatment

Point Ablation Catheter

Clinical Study ID

NCT06747013
STUDY-24-00971
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 forcatheter 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 andfollow-up requirements

  • Above 18 years of age

Exclusion

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 12months.

  • 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 ofprovocative 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 thyroiddisease or any reversible non-cardiac cause.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Point Ablation Catheter
Phase:
Study Start date:
January 07, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Icahn School of Medicine at Mount Sinai

    NYC, New York 10029
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

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