HFrEF patients without AF
Conditions
Interventions
After obtaining written consent, the principal (sub)investigator will implant the ILR subcutaneously in the left anterior thoracic region under local anaesthesia.
After implantation, arrhythmic events
Sponsors
Miyazaki Shinsuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with HFrEF (left ventricular ejection fraction <= 40%). 2.Patients with HFrEF who are receiving appropriate medical therapy and are on outpatient treatment or are able to go on outpatient treatment. 3.Patients with a CHADS2 score of 1 or higher. 4.Patients must be at least 20 years of age at the time of consent. 5.Patients who have given written consent to participate in this clinical study.
Exclusion criteria
Exclusion criteria: 1. Patients with implantable cardiac devices capable of detecting supraventricular arrhythmias (CIED: cardiovascular implantable electronic device. Refers to permanent pacemaker, implantable cardioverter defibrillator, ILR) 2.Patients with a diagnosis of AF at the time of consent. 3.Patients whose prognosis for life is considered to be within 1 year. 4.Patients who are immunocompromised. 5.Patients with active infection. 6.Patients with thin subcutaneous tissue at the implantation site that makes it difficult to safely implant the ILR. 7.Patients who are judged as ineligible for registration by attending doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with AF and non-sustained or sustained ventricular tachycardia AF:lasting more than 6 minutes. Non-sustained ventricular tachycardia:Tachycardia with a heart rate exceeding 150 beats / minute, 16 or more consecutive beats, and a duration of 30 seconds or less. Sustained ventricular tachycardia:Tachycardia with a heart rate exceeding 150 beats / minute and lasting more than 30 seconds. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Percentage of patients with pauses longer than 4.5 seconds. 2.Percentage of patients with bradycardia of less than 30 beats / min. 3.Percentage of patients with high degree atrioventricular block. 4.Percentage of patients treated with a permanent pacemaker,implantable cardioverter defibrillator,catheter ablation, or antiarrhythmic drug. 5.All-cause mortality 6.Cardiovascular mortality rate 7.Proportion of patients requiring hospitalization for cardiovascular disease or heart failure. 8.Percentage of patients who had a stroke. 9.Percentage of adverse events associated with ILR implantation 10.Percentage of device malfunction | — |
Contacts
Public ContactShinsuke Miyazaki
Institute of Science Tokyo Hospital
Outcome results
None listed