Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: January 07, 2025
End Date: December 01, 2025
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.