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

Description

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

Focal Ventricular Arrhythmias, Premature Ventricular Contractions, Ventricular Tachycardias

Study Overview

Study Details

Study overview

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.

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

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

Condition
Focal Ventricular Arrhythmias
Intervention / Treatment

-

Contacts and Locations

New York

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vivek Reddy,

Vivek Reddy, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2025-12-01