NIPH Clinical Trials Search

UMIN ID: UMIN000002372

Registered date:01/09/2009

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedTachyarrhythmia and Heart Failure
Date of first enrollment2009/05/01
Target sample size200
Countries of recruitmentJapan
Study typeObservational


Primary OutcomeA 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.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1. 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


public contact
Name Ruiko Nakashima
Address 1-19-19 Ebisu, Shibuya-ku, Tokyo Japan
Telephone 03-3473-7478
Affiliation Biotronik Japan Clinical Fellow
scientific contact
Name Eiichi Watanabe
Address Kutsukake-cho, Toyoake-city, Aichi, Japan Japan
Telephone 0562-93-2111
Affiliation Fujita Health University Hospital Cardiovascular Internal Medicine