Japanese Assessment of Indication Based Programming

Completed

• Conditions: Heart Failure; Arrhythmias, Cardiac
• Interventions: Other: No specific interventions

• Registration Number: NCT01143220
• Lead Sponsor: Boston Scientific Corporation

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 available

Study Timeline

• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Study Start: 2010-08
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICD / CRT-D patient	No specific interventions	Patients implanted with a single or dual chamber ICD or CRT-D device approved in Japan capable of using the IBP feature.

Primary Outcome Measures

Name	Time	Method
Proportion of patients that are programmed by the physician to anything other than the specific IBP parameter settings	Enrollment / Last available follow up during the first six months after implant	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.

Secondary Outcome Measures

Name	Time	Method
Degree of acceptance of IBP	Enrollment / Last available follow up during the first six months after implant	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	First six months after implant.
Proportion of patients without any IBP use at enrollment, but IBP use during follow up.	First six months after implant.
Proportion of patients with IBP use only at enrollment.	First six months after implant.
oProportion of patients with IBP use during enrollment and additional subsequent use of IBP during follow up.	First six months after implant.
Proportion of parameters changed per patient from nominal device settings.	First six months after implant.
Proportion of parameters changed per patient from IBP recommended device settings, if IBP was used.	First six months after implant.
Differences between nominal parameters and final programming by physicians for parameters with quantitative values.	First six months after implant.
Differences between parameters recommended by IBP and final programming by physicians for parameters with quantitative values	First six months after implant.
Total number of parameter changes recorded during the enrollment procedure after IBP recommendations were programmed.	First six months after implant.
Total number of parameter changes to a value different from the device nominals recorded during the enrollment procedure	First six months after implant.
oTotal number of parameter changes during follow up procedure(s)	First six months after implant.
Frequency of changes made to a single parameter during the time the patient is enrolled in the clinical investigation.	First six months after implant.

Trial Locations

Locations (45)

Social Insurance Chukyo Hospital; 🇯🇵 Nagoya, Aichi, Japan

Hiraka General Hospital; 🇯🇵 Yokote, Akita, Japan

Juntendo University Urayasu Hospital; 🇯🇵 Urayasu, Chiba Prefecture, Japan

Shin-Tokyo Hospital; 🇯🇵 Matsudo-city, Chiba-Prefecture, Japan

Kameda Medical Hospital; 🇯🇵 Kamogawa-city, Chiba, Japan

Saiseikai Imabari Hospital; 🇯🇵 Imabari, Ehime, Japan

Aso Iizuka Hospital; 🇯🇵 Iizuka, Fukuoka, Japan

Kokura Memorial Hospital; 🇯🇵 Kitakyusyu, Fukuoka, Japan

Shinkoga Hospital; 🇯🇵 Kurume, Fukuoka, Japan

Shinsapporo Hospital of Cardiology; 🇯🇵 Sapporo, Hokkaido, Japan

Scroll for more (35 remaining)