Focal Ventricular Arrhythmias, Premature Ventricular Contractions, Ventricular Tachycardias
Conditions
Keywords
Ventricular Arrhythmias, PVCs, Premature Ventricular Contractions, VT, Ventricular Tachycardias, Symptomatic Sustained Monomorphic Ventricular Tachycardia
Brief 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.
Detailed 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 60 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.
Interventions
DEVICEPoint Ablation Catheter
a point ablation catheter using a pulse field energy
Sponsors
Vivek Reddy
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single-arm clinical pilot study; all patients will undergo a standard ablation protocol using the study catheter (Farapoint).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from PVC/VT recurrence | at 3 months following ablation procedure | Freedom from PVC/VT recurrence 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. (Sustained Focal Tachycardia is defined as that persisting for \> 30 seconds or ventricular tachycardia which is sufficient to result in hemodynamic effect (i.e. hypotension or syncope)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse events | at 3 months following ablation procedure | Safety is measured as incidence of Serious Adverse Device Effects (SADEs) |
| Incidence of Serious Adverse Events (SAEs) | at 3 months following ablation procedure | Safety is measured as incidence of Serious Adverse Events (SAEs) |
| Incidence of non-serious adverse events | at 3 months following ablation procedure | Safety is measured as incidence of non-serious adverse events |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVivek Reddy, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed