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Enrolling By Invitation NCT06747013

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

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Vivek Reddy

Location: Icahn School of Medicine at Mount Sinai New York New York

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 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 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06747013). StuddyBuddy aggregates publicly available trial information.