Evaluation of the DuoVT PFA System for Ventricular Tachycardia

Ki vehet részt

• Sustained Monomorphic Ventricular Tachycardia (SMMVT) with Ischemic Cardiomyopathy (ICM); Patients with SMMVT and ischemic cardiomyopathy meet all of the following criteria:; History of myocardial infarction (MI); At least one episode of sustained (continuous for >30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia within the 180 days prior to enrollment; SMMVT recurrence despite class I or III antiarrhythmic drug therapy, or when AAD therapy is not tolerated, contraindicated or not desired; Implanted with an ICD (transvenous or subcutaneous) or CRT-D prior to the index ablation; for transvenous systems, leads must be implanted ≥30 days prior
• Frequent premature ventricular complexes (PVCs) meeting class II a/b indications for ablation with documentation of PVCs on 24-Hour monitor in the 90 days prior to enrollment. Subjects should meet one or more of the following criteria:; Symptomatic PVCs when class I or III AADs have failed, are not tolerated, or are not desired (class II a); Suspected PVC-induced cardiomyopathy (>10% burden) (class II a); Frequent PVCs in patients with structural heart disease (>10% burden) (class II a); Asymptomatic, high burden PVCs (>15% burden) (class II b); Age 18 through 80 years old 3. Willing and able to provide written informed consent 4. Willing and able to comply with the study visit schedule and requirements

Ki nem vehet részt

• Unstable angina within the prior 60 days
• Myocardial infarction within 60 days prior to the ablation procedure
• Any percutaneous coronary intervention within 60 days prior to the ablation procedure
• Any cardiac surgery within 90 days prior to the ablation procedure
• Currently receiving support or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO)
• Thromboembolic event (stroke or transient ischemic attack) within 90 days prior to the index ablation procedure
• Currently being evaluated for an organ transplant
• Participation in another investigational study or treatment with any investigational drug within the previous 30 days that would interfere with this study. Each instance must be brought to the attention of the Sponsor to determine eligibility
• Any of the following:; Any ablation procedure for VT or PVC within the previous 90 days of enrollment, or; More than 1 ablation procedure for VT or PVC within the previous 365 days of enrollment; SMMVT only exclusions:
• Incessant VT necessitating hemodynamic support prior to the ablation procedure
• Cardiac Conditions
• Active myocardial ischemia
• NYHA Class IV heart failure
• Decompensated heart failure at the time of enrollment
• The Micra™ Leadless Cardiac Implantable Electronic Device (CIED) or CIEDs with a left ventricular endocardial lead
• Prohibitively distorted cardiac anatomy due to congenital heart disease; Vascular and Thromboembolic Conditions
• Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
• Active infection or sepsis
• Serious or untreated medical conditions that would prevent participation in the study, interfere with assessment or therapy, or confound data or its interpretation
• VTs due to any of the following:; Automaticity or triggered activity; Lamin or titin genetic mutation; VT secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug-induced arrhythmia)
• Left ventricular ejection fraction (LVEF) < 15%
• Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count < 80,000)
• Chronic renal insufficiency of eGFR < 30 mL/min/1.73 m²; Systemic and General Medical Conditions
• General Exclusion Criteria:
• Ventricular assist device (VAD) implanted, planned, or required for the procedure
• Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation
• Tricuspid or mitral valve replacement or repair (inclusive of Mitral/Tricuspid clips) or prosthetic valve procedure
• Presence of intracardiac thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
• Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging
• Contraindication to anticoagulation; Pulmonary and Renal
• Life expectancy less than 12 months
• Body mass index > 40 kg/m²
• Pregnancy or breastfeeding; Study-Related Exclusions
• Patient is not able to understand the nature of this study or is unwilling or unable to attend the study procedures
• Non-ischemic cardiomyopathy (NICM)
• Hypertrophic cardiomyopathy, except when due to an apical aneurysm
• Unstable polymorphic VT or ventricular fibrillation (VF)
• VT or VF thought to be from channelopathies