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

Vivek Reddy

Status

Enrolling

Conditions

Premature Ventricular Contractions

Ventricular Tachycardias

Focal Ventricular Arrhythmias

Treatments

Device: Point Ablation Catheter

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06747013

STUDY-24-00971

Details and patient eligibility

About

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.

Full description

Study Design - This is a prospective, single-center, single-arm clinical pilot study to assess the safety and effectiveness of ablation of focal ventricular arrhythmias using the Farapoint catheter.

Sample Size - A total of 30 subjects will be included in this study. All patients will undergo treatment with the study PFA catheter.

Study Population - The target population is subjects who are planned to undergo a clinically-indicated ablation procedure for managing their focal ventricular arrhythmias - premature ventricular contractions or ventricular tachycardias.

Study Duration - Approximately 12 months: 3 months site start-up, 6 months enrollment and 3 months of follow up.

Participant Duration - Subjects will undergo brief pre-procedural testing, the ablation procedure, and 3 months of post-procedural follow up.

Primary Effectiveness Endpoint Chronic Single-Procedure Success: defined as a reduction in the burden of premature ventricular contracts (>80%) for patients treated for PVCs or absence of sustained focal ventricular tachycardia for patients being treated for focal VTs without an increase in anti-arrhythmic medications at 3 month follow ups.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.