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Enrolling by invitation NCT06747013

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

No phase Interventional Focal Ventricular Arrhythmias Premature Ventricular Contractions Ventricular Tachycardias

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Point Ablation Catheter.
Who it may be relevant to
Registry conditions: Focal Ventricular Arrhythmias, Premature Ventricular Contractions, Ventricular Tachycardias. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Device Point Ablation Catheter
    a point ablation catheter using a pulse field energy

Primary outcome measures

  • Freedom from PVC/VT recurrence [Time frame: at 3 months following ablation procedure]
Secondary outcome measures (3)
  • Incidence of Adverse events [Time frame: at 3 months following ablation procedure]
  • Incidence of Serious Adverse Events (SAEs) [Time frame: at 3 months following ablation procedure]
  • Incidence of non-serious adverse events [Time frame: at 3 months following ablation procedure]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Icahn School of Medicine at Mount Sinai — New York

Identifiers

NCT: NCT06747013 · STUDY-24-00971

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗