Japanese Assessment of Indication Based Programming (JASMINE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Guidant Corporation

ClinicalTrials.gov Identifier:

NCT01143220

First received: June 11, 2010

Last updated: October 8, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 11, 2010
Last Updated Date	October 8, 2012
Start Date ^ICMJE	August 2010
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 11, 2010)	Proportion of patients that are programmed by the physician to anything other than the specific IBP parameter settings [ Time Frame: Enrollment / Last available follow up during the first six months after implant ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01143220 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 11, 2010)	Degree of acceptance of IBP [ Time Frame: Enrollment / Last available follow up during the first six months after implant ] [ Designated as safety issue: No ] 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. Proportion of patients without any IBP use [ Time Frame: First six months after implant. ] [ Designated as safety issue: No ] Proportion of patients without any IBP use at enrollment, but IBP use during follow up. [ Time Frame: First six months after implant. ] [ Designated as safety issue: No ] Proportion of patients with IBP use only at enrollment. [ Time Frame: First six months after implant. ] [ Designated as safety issue: No ] oProportion of patients with IBP use during enrollment and additional subsequent use of IBP during follow up. [ Time Frame: First six months after implant. ] [ Designated as safety issue: No ] Proportion of parameters changed per patient from nominal device settings. [ Time Frame: First six months after implant. ] [ Designated as safety issue: No ] Proportion of parameters changed per patient from IBP recommended device settings, if IBP was used. [ Time Frame: First six months after implant. ] [ Designated as safety issue: No ] Differences between nominal parameters and final programming by physicians for parameters with quantitative values. [ Time Frame: First six months after implant. ] [ Designated as safety issue: No ] Differences between parameters recommended by IBP and final programming by physicians for parameters with quantitative values [ Time Frame: First six months after implant. ] [ Designated as safety issue: No ] Total number of parameter changes recorded during the enrollment procedure after IBP recommendations were programmed. [ Time Frame: First six months after implant. ] [ Designated as safety issue: No ] Total number of parameter changes to a value different from the device nominals recorded during the enrollment procedure [ Time Frame: First six months after implant. ] [ Designated as safety issue: No ] oTotal number of parameter changes during follow up procedure(s) [ Time Frame: First six months after implant. ] [ Designated as safety issue: No ] Frequency of changes made to a single parameter during the time the patient is enrolled in the clinical investigation. [ Time Frame: First six months after implant. ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Japanese Assessment of Indication Based Programming
Official Title ^ICMJE	Japanese Assessment of Indication Based Programming
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 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	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	The patient population comprises the standard patient population of the participating sites indicated for the intended devices per local guidelines in the study centers.
Condition ^ICMJE	Heart Failure Arrhythmias, Cardiac
Intervention ^ICMJE	Other: No specific interventions Observational investigation, only procedures according to local hospital standard. Other Name: No specific interventions
Study Group/Cohort (s)	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. Intervention: Other: No specific interventions
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	235
Completion Date	September 2012
Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	20 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01143220
Other Study ID Numbers ^ICMJE	JASMINE 0709
Has Data Monitoring Committee	No
Responsible Party	Guidant Corporation
Study Sponsor ^ICMJE	Guidant Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Guidant Corporation
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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