ventricular tachycardia
Conditions
Interventions
ICD with medical management
ICD with catheter ablation. Main strategy is scar-based ablation with targeting of late potentials defined as low voltage potentials with fractionated, split, or delayed
Sponsors
University of Tsukuba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient is receiving a new ICD or CRT-D implant, that has study required programing capabilities and is appropriate for remote monitoring. Patient who has received the ICD / CRT-D within 90 days of enrollment can also be enrolled. 2) Patient who has a high risk of ICD shock as shown by documented Monomorphic VT (MMVT) by one or more of the following: Spontaneous MMVT, inducible MMVT during EP Study, inducible MMVT during NIPS Study. *Inducible MMVT is defined as MMVT > 30 seconds or requiring electrical termination ( ATP or cardioversion) 3) Patient has EF < 50% or RV dysfunction 4) Patient has a cardiomyopathy with structural heart disease of any cause 5) 18 years of age or older 6) Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent approved by the Institutional Review Board.
Exclusion criteria
Exclusion criteria: 1) Any history of debilitating stroke with neurologic deficit 2) ST elevation MI or previous cardiac surgery within 60 days prior to enrollment 3) Patient is pregnant or nursing 4) Patient has chronic NYHA class IV heart failure 5) Patient has incessant VT necessitating immediate treatment 6) Patient has VT/VF thought to be from channelopathies 7) Limited life expectancy (less than one year) 8) Patient has current class IV angina 9) Recent CABG or PCI (< 45 days) 10) Patient is currently participating in another investigational drug or device study 11) Patient is unable or unwilling to cooperate with the study procedures 12) Known presence of intracardiac thrombi 13) Prosthetic mitral or aortic valve or mitral or aortic valvular heart disease requiring immediate surgical intervention 14) Major contraindication to anticoagulation therapy or coagulation disorder 15) Left Ventricular Ejection Fraction < 15% 16) Patient has had a previous ablation procedure for VT, excluding remote (> 3 months) outflow tract tachycardia 17) Patient has GFR < 30 mL/min/1.73m2 18) Patient has peripheral vascular disease that precludes LV access 19) Patient is thought to have idiopathic outflow VT as only VT 20) Patient has a PVC or VT induced cardiomyopathy that is expected to resolve with ablation and will not require an ICD 21) Patient has reversible cause of VT 22) Patient does not meet criteria for ICD or CRT-D
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is defined as freedom from any ICD therapy, including ATP or shocks and all-cause mortality through a period of 2 years after the procedure (ablation) or randomization (standard medical therapy). | — |
Countries
Japan,Asia(except Japan),North America
Contacts
Public ContactAkihiko Nogami
University of Tsukuba Cardiovascular Division, Faculty of Medicine
Outcome results
None listed