Clinical trial NCT06747013: Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA
Official title: Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Focal Ventricular Arrhythmias
Premature Ventricular Contractions
Ventricular Tachycardias
Keywords: Ventricular Arrhythmias
PVCs
Premature Ventricular Contractions
VT
Ventricular Tachycardias
Symptomatic Sustained Monomorphic Ventricular Tachycardia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2024-12-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm clinical pilot study; all patients will undergo a standard ablation protocol using the study catheter (Farapoint).
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from PVC/VT recurrence
timeFrame: at 3 months following ablation procedure
Secondary outcomes:
measure: Incidence of Adverse events
timeFrame: at 3 months following ablation procedure
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: at 3 months following ablation procedure
measure: Incidence of non-serious adverse events
timeFrame: at 3 months following ablation procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: