Japanese Assessment of Indication Based Programming

Heart Failure Clinical Trial

— JASMINE  

Official title:

Japanese Assessment of Indication Based Programming

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143220
• Other study ID #: JASMINE 0709
• Status: Completed
• Phase: N/A
• First received: June 11, 2010
• Last updated: February 17, 2017
• Start date: August 2010
• Est. completion date: September 2012

Study information

• Verified date: February 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Heart Failure

Intervention

Other:
• No specific interventions
Observational investigation, only procedures according to local hospital standard.

Locations

Country	Name	City	State
Japan	Fukuoka University Hospital	Fukuoka
Japan	Hamamatsu Medical Center	Hamamatsu	Shizuoka
Japan	Seirei Hamamatsu General Hospital	Hamamatsu City	Shizuoka
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Yamaguchi Grand Medical Center	Hofu-city	Yamaguchi
Japan	Aso Iizuka Hospital	Iizuka	Fukuoka
Japan	Saiseikai Imabari Hospital	Imabari	Ehime
Japan	Yamada Red Cross Hospital	Ise	Mie
Japan	Tokai University Hospital	Isehara	Kanagawa
Japan	Juntendo University Shizuoka Hospital	Izunokuni	Shizuoka
Japan	Kameda Medical Hospital	Kamogawa-city	Chiba
Japan	Kanazawa Cardiovascular Hospital	Kanazawa-City	Ishikawa
Japan	Kokura Memorial Hospital	Kitakyusyu	Fukuoka
Japan	Kumamoto Central Hospital	Kumamoto
Japan	Saiseikai Kumamoto Hospital	Kumamoto
Japan	Shinkoga Hospital	Kurume	Fukuoka
Japan	Kyoto Katsura Hospital	Kyoto
Japan	Kyoto Prefectual University of Medicine Hospital	Kyoto
Japan	Shin-Tokyo Hospital	Matsudo-city	Chiba-Prefecture
Japan	Matsumoto Kyoritsu Hospital	Matsumoto City	Nagano
Japan	Nagano Red Cross Hospital	Nagano
Japan	Nagano Chuo Hospital	Nagano-city	Nagano Prefecture
Japan	Social Insurance Chukyo Hospital	Nagoya	Aichi
Japan	Niigata University Medical and Dental Hospital	Niigata
Japan	Sakurabashi Watanabe Hospital	Osaka
Japan	Iseikai Hospital	Osaka-city	Osaka
Japan	Kinki University Hospital	Osakasayama-city	Osaka
Japan	Hokkaido Medical Center	Sapporo	Hokkaido
Japan	Hokkaido Social Insurance Hospital	Sapporo	Hokkaido
Japan	Hokko Memorial Hospital	Sapporo	Hokkaido
Japan	Shinsapporo Hospital of Cardiology	Sapporo	Hokkaido
Japan	Teine Keijinkai Hospital	Sapporo	Hokkaido
Japan	Yamaguchi-ken Saiseikai Shimonoseki General Hospital	Shimonoseki	Yamaguchi
Japan	Dokkyo Medical University Hospital	Shimotsuga-gun	Tochigi
Japan	Juntendo University Hospital	Tokyo
Japan	Keio University Hospital	Tokyo
Japan	Ogikubo Hospital	Tokyo
Japan	The University of Tokyo Hospital	Tokyo
Japan	Toho University Ohashi Medical Center	Tokyo
Japan	Tokyo Heart Center Osaki Hospital	Tokyo
Japan	Tokyo Women's Medical University Medical Center East	Tokyo
Japan	Uji Tokushukai Hospital	Uji	Kyoto
Japan	Juntendo University Urayasu Hospital	Urayasu	Chiba Prefecture
Japan	Yokohama Rosai Hospital	Yokohama	Kanagawa
Japan	Hiraka General Hospital	Yokote	Akita

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Guidant Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients that are programmed by the physician to anything other than the specific IBP parameter settings	The primary endpoint is the proportion of patients that are programmed by the physician to anything other than the specific IBP parameter settings determined for the particular patient. The specific IBP parameter set is determined either by the physician using the IBP feature or by creating the most appropriate set of IBP parameters using the information given in the patient history section of the CRF. Each IBP recommended parameter will be evaluated individually.	Enrollment / Last available follow up during the first six months after implant
Secondary	Degree of acceptance of IBP	Measured by a composite endpoint on a 0 to 100 scale, reflecting all parameter changes for each patient between the IBP recommended parameter set and finally programmed parameter set of the last recorded visit. The impact on the endpoint will vary by the parameter reprogrammed. Weights will be determined for each parameter based upon the relevance of the parameter to the overall acceptance of the IBP algorithm.	Enrollment / Last available follow up during the first six months after implant
Secondary	Proportion of patients without any IBP use		First six months after implant.
Secondary	Proportion of patients without any IBP use at enrollment, but IBP use during follow up.		First six months after implant.
Secondary	Proportion of patients with IBP use only at enrollment.		First six months after implant.
Secondary	oProportion of patients with IBP use during enrollment and additional subsequent use of IBP during follow up.		First six months after implant.
Secondary	Proportion of parameters changed per patient from nominal device settings.		First six months after implant.
Secondary	Proportion of parameters changed per patient from IBP recommended device settings, if IBP was used.		First six months after implant.
Secondary	Differences between nominal parameters and final programming by physicians for parameters with quantitative values.		First six months after implant.
Secondary	Differences between parameters recommended by IBP and final programming by physicians for parameters with quantitative values		First six months after implant.
Secondary	Total number of parameter changes recorded during the enrollment procedure after IBP recommendations were programmed.		First six months after implant.
Secondary	Total number of parameter changes to a value different from the device nominals recorded during the enrollment procedure		First six months after implant.
Secondary	oTotal number of parameter changes during follow up procedure(s)		First six months after implant.
Secondary	Frequency of changes made to a single parameter during the time the patient is enrolled in the clinical investigation.		First six months after implant.