RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-07

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06747013

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Betsy Ellsworth, MSN

CONTACT

347-498-3855

betsy.ellsworth@mountsinai.org

Devin Chamberlain, BS

CONTACT

347-498-3855

devin.chamberlain@mountsinai.org

Principal Investigator

Vivek Reddy, MD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Vivek Reddy

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-07

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2025-01-07

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Focal Ventricular Arrhythmias
Premature Ventricular Contractions
Ventricular Tachycardias