Heart failure
Conditions
Interventions
None listed
Sponsors
Department of Cardiology Fujita Health University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 or above 2. Willing to participate in all testing associated with this clinical investigation at an clinical investigational center 3. Currently implanted with an INCEPTA device 4. Classified as NYHA Class II - IV within the last six months 5. Indication of the ICD CRT-D implantation along with ACC/AHA/HRS 2008 Guidelines for Device-based Therapy of Cardiac Rhythm Abnormalities
Exclusion criteria
Exclusion criteria: Inability or refusal to sign the Subject Informed Consent or inability of refusal to comply with the follow-up schedule Contraindication for ICD or CRT-D Have received or will receive heart transplant Receiving mechanical circulatory support A life expectancy of less than 12 months due to non-cardiac cause Documented as pacemaker dependent Pregnant or lactating Less than 18 years of age Enrolled in any other clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute exacerbation of heart failure | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine associations betwen changes in the biosignal including respiratory rate, sleep disordered bleething, heart rate, and patient activity and clinical characteristics or clinical outcomes | — |
Countries
Japan
Contacts
Public ContactEiichi Watanabe
Fujita Health University School of Medicine Department of Cardiology
Outcome results
None listed