Tachyarrhythmia and Heart Failure
Conditions
Interventions
None listed
Sponsors
Biotronik Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Indicated for ICD or CRT-D implantation under Japanese guidelines. 2.Implanted within the last 10 days (or being considered for implant) with a BIOTRONIK Lumax device. 3.Patients that are geographically stable and are able to attend the follow-up investigations according to the protocol. 4.The patient unerstands the nature of procedure. 5. Patients that have been informed about the investigation, that have read and understood the patient information and have signed the declaration of patient informed consent. 6. The Patient is able to complete all testing required by the clinical investigation plan.
Exclusion criteria
Exclusion criteria: 1. Contraindicated for ICD or CRT-D implantation under Japanese guidelines. 2. Patients who are not able to handle the system correctly. 3. Patients who are currently included in another cardiac clinical study. 4. Patient with life expectancy of less than 12 months. 5. Patient expected to recieve heart implantation within twelve months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A PRE Follow-Up assessment based on the Cardio Reports is completed to forecast the necessity of the follow up. This is compared with a POST Follow-Up assessment which is completed after the scheduled follow-up. It is expected that at most 5 % of the decisions are false negative. | — |
Countries
Japan
Contacts
Public ContactRuiko Nakashima
Biotronik Japan Clinical Fellow
Outcome results
None listed