Japanese Assessment of Indication Based Programming

NCT ID: NCT01143220

Last Updated: 2017-02-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-09-30

Brief Summary

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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 based on the patient's clinical needs and primary indications will be evaluated by comparing parameters determined by the feature IBP to daily life programming chosen by physicians.

Detailed Description

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Conditions

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Heart Failure Arrhythmias, Cardiac

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guidant Corporation

INDUSTRY

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Social Insurance Chukyo Hospital

Nagoya, Aichi-ken, Japan

Site Status

Hiraka General Hospital

Yokote, Akita, Japan

Site Status

Kameda Medical Hospital

Kamogawa, Chiba, Japan

Site Status

Shin-Tokyo Hospital

Matsudo, Chiba, Japan

Site Status

Juntendo University Urayasu Hospital

Urayasu, Chiba, Japan

Site Status

Saiseikai Imabari Hospital

Imabari, Ehime, Japan

Site Status

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

Site Status

Aso Iizuka Hospital

Iizuka, Fukuoka, Japan

Site Status

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Site Status

Shinkoga Hospital

Kurume, Fukuoka, Japan

Site Status

Shinsapporo Hospital of Cardiology

Sapporo, Hokkaido, Japan

Site Status

Teine Keijinkai Hospital

Sapporo, Hokkaido, Japan

Site Status

Hokkaido Social Insurance Hospital

Sapporo, Hokkaido, Japan

Site Status

Hokkaido Medical Center

Sapporo, Hokkaido, Japan

Site Status

Hokko Memorial Hospital

Sapporo, Hokkaido, Japan

Site Status

Kanazawa Cardiovascular Hospital

Kanazawa, Ishikawa-ken, Japan

Site Status

Tokai University Hospital

Isehara, Kanagawa, Japan

Site Status

Yokohama Rosai Hospital

Yokohama, Kanagawa, Japan

Site Status

Saiseikai Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Site Status

Kumamoto Central Hospital

Kumamoto, Kumamoto, Japan

Site Status

Kyoto Katsura Hospital

Kyoto, Kyoto, Japan

Site Status

Kyoto Prefectual University of Medicine Hospital

Kyoto, Kyoto, Japan

Site Status

Uji Tokushukai Hospital

Uji, Kyoto, Japan

Site Status

Yamada Red Cross Hospital

Ise, Mie-ken, Japan

Site Status

Matsumoto Kyoritsu Hospital

Matsumoto, Nagano, Japan

Site Status

Nagano Chuo Hospital

Nagano, Nagano, Japan

Site Status

Nagano Red Cross Hospital

Nagano, Nagano, Japan

Site Status

Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan

Site Status

Sakurabashi Watanabe Hospital

Osaka, Osaka, Japan

Site Status

Iseikai Hospital

Osaka, Osaka, Japan

Site Status

Kinki University Hospital

Sayama, Osaka, Japan

Site Status

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Site Status

Hamamatsu Medical Center

Hamamatsu, Shizuoka, Japan

Site Status

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Site Status

Juntendo University Shizuoka Hospital

Izunokuni, Shizuoka, Japan

Site Status

Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi, Japan

Site Status

Juntendo University Hospital

Tokyo, Tokyo, Japan

Site Status

The University of Tokyo Hospital

Tokyo, Tokyo, Japan

Site Status

Tokyo Women's Medical University Medical Center East

Tokyo, Tokyo, Japan

Site Status

Tokyo Heart Center Osaki Hospital

Tokyo, Tokyo, Japan

Site Status

Toho University Ohashi Medical Center

Tokyo, Tokyo, Japan

Site Status

Keio University Hospital

Tokyo, Tokyo, Japan

Site Status

Ogikubo Hospital

Tokyo, Tokyo, Japan

Site Status

Yamaguchi Grand Medical Center

Hōfu, Yamaguchi, Japan

Site Status

Yamaguchi-ken Saiseikai Shimonoseki General Hospital

Shimonoseki, Yamaguchi, Japan

Site Status

Countries

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Japan

Other Identifiers

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JASMINE 0709

Identifier Type: -

Identifier Source: org_study_id

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