Status:
COMPLETED
Japanese Assessment of Indication Based Programming
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
Guidant Corporation
Conditions:
Heart Failure
Arrhythmias, Cardiac
Eligibility:
All Genders
20+ years
Brief Summary
The purpose of this clinical investigation is to assess the programming behavior of the physicians in the patient cohort. Furthermore, the acceptance level of specific programming recommendations base...
Eligibility Criteria
Inclusion
- Implanted with a single or dual chamber ICD or CRT-D device approved in Japan capable of using the IBP feature.
- Geographically stable patients who are available for follow-up at a study center .
- Age 20 years or above.
- Patients, who do receive all leads that are supposed to be used with a certain type of device (i.e. no dual chamber ICD / CRT-D device without an atrial lead or CRT-D devices with only one ventricular lead).
Exclusion
- Inability or refusal of the patient to give approval to collect/store/process personal health information at the sponsor.
- Pregnant women or women, planning to become pregnant .
- Any kind of previous CRM device therapy (no replacements, no upgrades, no new implants after complete system removals ).
- Enrolment in another clinical trial or clinical investigation without prior notification of the sponsor .
- Estimated life expectancy of less than six months per judgment of the physician.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT01143220
Start Date
August 1 2010
End Date
September 1 2012
Last Update
February 23 2017
Active Locations (45)
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1
Social Insurance Chukyo Hospital
Nagoya, Aichi-ken, Japan, 457-8510
2
Hiraka General Hospital
Yokote, Akita, Japan, 013-8610
3
Kameda Medical Hospital
Kamogawa, Chiba, Japan, 296-8602
4
Shin-Tokyo Hospital
Matsudo, Chiba, Japan, 271-0077