Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
235 participants
OBSERVATIONAL
2010-08-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ICD / CRT-D patient
Patients implanted with a single or dual chamber ICD or CRT-D device approved in Japan capable of using the IBP feature.
No specific interventions
Observational investigation, only procedures according to local hospital standard.
Interventions
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No specific interventions
Observational investigation, only procedures according to local hospital standard.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
20 Years
ALL
No
Sponsors
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Guidant Corporation
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Responsible Party
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Locations
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Social Insurance Chukyo Hospital
Nagoya, Aichi-ken, Japan
Hiraka General Hospital
Yokote, Akita, Japan
Kameda Medical Hospital
Kamogawa, Chiba, Japan
Shin-Tokyo Hospital
Matsudo, Chiba, Japan
Juntendo University Urayasu Hospital
Urayasu, Chiba, Japan
Saiseikai Imabari Hospital
Imabari, Ehime, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Aso Iizuka Hospital
Iizuka, Fukuoka, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Shinkoga Hospital
Kurume, Fukuoka, Japan
Shinsapporo Hospital of Cardiology
Sapporo, Hokkaido, Japan
Teine Keijinkai Hospital
Sapporo, Hokkaido, Japan
Hokkaido Social Insurance Hospital
Sapporo, Hokkaido, Japan
Hokkaido Medical Center
Sapporo, Hokkaido, Japan
Hokko Memorial Hospital
Sapporo, Hokkaido, Japan
Kanazawa Cardiovascular Hospital
Kanazawa, Ishikawa-ken, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Yokohama Rosai Hospital
Yokohama, Kanagawa, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Kumamoto Central Hospital
Kumamoto, Kumamoto, Japan
Kyoto Katsura Hospital
Kyoto, Kyoto, Japan
Kyoto Prefectual University of Medicine Hospital
Kyoto, Kyoto, Japan
Uji Tokushukai Hospital
Uji, Kyoto, Japan
Yamada Red Cross Hospital
Ise, Mie-ken, Japan
Matsumoto Kyoritsu Hospital
Matsumoto, Nagano, Japan
Nagano Chuo Hospital
Nagano, Nagano, Japan
Nagano Red Cross Hospital
Nagano, Nagano, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
Sakurabashi Watanabe Hospital
Osaka, Osaka, Japan
Iseikai Hospital
Osaka, Osaka, Japan
Kinki University Hospital
Sayama, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Hamamatsu Medical Center
Hamamatsu, Shizuoka, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Juntendo University Shizuoka Hospital
Izunokuni, Shizuoka, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, Japan
Juntendo University Hospital
Tokyo, Tokyo, Japan
The University of Tokyo Hospital
Tokyo, Tokyo, Japan
Tokyo Women's Medical University Medical Center East
Tokyo, Tokyo, Japan
Tokyo Heart Center Osaki Hospital
Tokyo, Tokyo, Japan
Toho University Ohashi Medical Center
Tokyo, Tokyo, Japan
Keio University Hospital
Tokyo, Tokyo, Japan
Ogikubo Hospital
Tokyo, Tokyo, Japan
Yamaguchi Grand Medical Center
Hōfu, Yamaguchi, Japan
Yamaguchi-ken Saiseikai Shimonoseki General Hospital
Shimonoseki, Yamaguchi, Japan
Countries
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Other Identifiers
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JASMINE 0709
Identifier Type: -
Identifier Source: org_study_id
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