Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation C… (NCT06747013) | Clinical Trial Compass
By InvitationNot Applicable
Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA
United States60 participantsStarted 2025-01-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Freedom from PVC/VT recurrence
Timeframe: at 3 months following ablation procedure