heart failure, ventricular fibrillation
Conditions
Interventions
None listed
Sponsors
Nihon University
Nihon University Itabashi Hospital Nihon University Hospital Kanazawa University Hospital Kawaguchi Municipal Medical Center Kitasato University Hospital Juntendo University Hospital Tokyo Bay Urayasu/Ichikawa Medical Center Dokkyo Medical University Saitama Medical Center Fujita Health University Hospital Shonan Kamakura General Hospital Nihon Medical Center Tokyo Metropolitan Hiroo Hospital Kobe University Hospital National Cerebral and Cardiovascular Center St. Marianna Universi
s Medical University Hospital Ogaki Municipal Hospital Saitama Medical University International Medical Center Jichi Medical University Hospital Yamagata University Hospital Kagoshima University Hospital Hirosaki University Hospital Chiba University Hospital Sendai Kousei Hospital National Hospital Organization Kanazawa Medical Center Yamaguchi Prefectural Grand Medical Center Saiseikai Kumamoto Hospital Shinkoga Hospital Showa University Hospital Showa University Koto Toyosu Hospi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Heart failure cases that meet the indication criteria for each device according to the guidelines in Japan. <ICD primary prevention indication patients> Patients who meet all of the following criteria: 1.Sufficient drug therapy 2.Left ventricular ejection fraction (LVEF) <=35% 3.Heart failure symptoms of NYHA functional class II or higher <ICD secondary prevention indication patients> Patients with LVEF <=35%, NYHA functional class II or higher heart failure symptoms, after excluding reversible factors, who meet one of the following criteria: 1.Out-of-hospital cardiac arrest with ventricular fibrillation or electric shock 2.Persistent ventricular tachycardia 3.Unexplained syncope <WCD indication patients> Patients who meet one of the following criteria: 1.Within 40 days after onset of acute myocardial infarction with NYHA functional class II-III heart failure symptoms and LVEF <= 35% 2.Within 90 days after coronary artery bypass grafting or percutaneous coronary intervention with NYHA functional class II-III heart failure symptoms and LVEF <= 35% 3.Within 90 days after onset of non-ischemic acute heart failure with LVEF <=35%
Exclusion criteria
Exclusion criteria: 1.Patients who cannot expect to live longer than 12 months 2.Patients with recurrent VT or Vf that cannot be controlled with antiarrhythmic drugs or catheter ablation 3.Patients with drug-resistant severe congestive heart failure (NYHA class4) who are not candidates for heart transplantation, CRT, or LVAD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| device introduction rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of VT/VF and presence of sudden death 2.All-cause mortality 3.Cardiovascular events (cardiovascular death, hospitalization due to heart failure, and other cardiovascular events requiring hospitalization) 4.Stroke/TIA and systemic embolism 5.Myocardial infarction and unstable angina 6.Heart failure requiring hospitalization and other cardiovascular events requiring hospitalization 7.Major bleeding 8.Clinically relevant non-major bleeding 9.Major bleeding or clinically relevant non-major bleeding 10.Cardiovascular death 11.Other deaths 12.Device complications | — |
Countries
Japan
Contacts
Public ContactYukitoshi Ikeya
Nihon University School of Medicine Department of Medicine, Division of Cardiology
Outcome results
None listed