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