Reliability of Implantable Cardioverter-Defibrillator Home Monitoring in Forecasting the Necessity of Regular Office Visit and Patients' Perspectives: Japanese HOME ICD Study

UMIN ID: UMIN000002372

Registered date:01/09/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Tachyarrhythmia and Heart Failure
• Date of first enrollment: 2009/05/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Biotronik Japan
• Source(s) of Monetary Support: Biotronik Japan