Ventricular tachycardia, ventricular fibrillation
Conditions
Interventions
Use of a home-use infrared therapy device for the treatment of life-threatening arrhythmias in patients with an implanted left ventricular assist device who have ventricular tachycardia or ventricular
Sponsors
Takeda Norihiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with an implanted left ventricular assist device (LVAD) (2) Patients diagnosed with ventricular tachycardia or ventricular fibrillation (3) Patients in whom conventional therapy (pharmacotherapy, catheter ablation, or ICD) is unlikely to improve ventricular tachycardia or ventricular fibrillation (4) Patients with an implanted implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy defibrillator (CRT-D) (5) Age: 18 years or older at the time of obtaining informed consent (6) Sex: no restriction (7) Patients who can visit the outpatient clinic according to the study schedule (8) Patients who have received sufficient explanation about this study, fully understood the content, and provided written informed consent of their own free will
Exclusion criteria
Exclusion criteria: (1) Patients with a history of hypersensitivity to infrared light (2) Patients whom the principal investigator or sub-investigator judges to be inappropriate for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in arrhythmic event duration from baseline to Week 12 after treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Percent change in arrhythmic event duration from baseline to Weeks 4 and 8 after treatment initiation (2) Percent change in the number of arrhythmic events from baseline to Weeks 4, 8, and 12 after treatment initiation (3) Change in NT-proBNP levels from baseline to Weeks 4, 8, and 12 after treatment initiation (4) Percent change in the number of ICD therapies from baseline to Weeks 4, 8, and 12 after treatment initiation (5) Implementation rate of home-use infrared therapy during the 12-week treatment period (6) Frequency and proportion of adverse events (7) Frequency of device malfunctions | — |
Contacts
Public ContactTsukasa Oshima
The University of Tokyo Hospital
Outcome results
None listed