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

ID#: NCT06747013

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: January 07, 2025

End Date: December 01, 2025

Contact Information:
Betsy Ellsworth, MSN
347-498-3855
Devin Chamberlain, BS
347-498-3855
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:

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.