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

NCT06747013 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: STUDY-24-00971
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardias; Focal Ventricular Arrhythmias; Premature Ventricular Contractions

Keywords

Ventricular Arrhythmias; PVCs; Premature Ventricular Contractions; VT; Ventricular Tachycardias; Symptomatic Sustained Monomorphic Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of Adverse events

  at 3 months following ablation procedure

• Incidence of Serious Adverse Events (SAEs)

  at 3 months following ablation procedure

• Incidence of non-serious adverse events

  at 3 months following ablation procedure

Study Arms (1)

Ablation using study catheter

EXPERIMENTAL

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

Device: Point Ablation Catheter

Interventions

Point Ablation Catheter DEVICE

a point ablation catheter using a pulse field energy

Also known as: Farapoint

Ablation using study catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivek Reddy: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Ventricular Premature Complexes; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Arrhythmia Service MSHS

Model Details: single-arm clinical pilot study; all patients will undergo a standard ablation protocol using the study catheter (Farapoint).

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)