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

Launched by VIVEK REDDY · Dec 18, 2024

Keywords

ClinConnect Summary

The FOCUS-PFA clinical trial is studying a new treatment option for patients with certain heart rhythm problems, specifically focal ventricular arrhythmias like premature ventricular contractions (PVCs) and ventricular tachycardia. This trial is using a special tool called a point ablation catheter, which targets and helps to eliminate the faulty electrical signals in the heart using pulsed field energy. The goal is to see if this method can effectively treat these conditions and improve patients' heart health.

To participate in this study, you need to be at least 18 years old and scheduled for a catheter ablation procedure for either symptomatic sustained ventricular tachycardia or PVCs that meet specific guidelines. Participants should be willing to sign consent and follow all study requirements. However, there are some criteria that may prevent participation, such as certain heart conditions, severe illnesses, or if you are currently pregnant. If you join the trial, you can expect to receive treatment and monitoring to assess how well this new approach works for your specific heart issues.

Gender

ALL

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.