점절제 카테터의 펄스장 절제를 이용한 초점성 심실성 빈맥의 치료 짧은 제목 FOCUS-PFA (FOCUS PFA)

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.