Japanese Assessment of Indication Based Programming (JASMINE)

Boston Scientific

Status: Completed

Conditions: Arrhythmias, Cardiac; Heart Failure

Treatments: Other: No specific interventions

Study type: Observational

Funder types: Industry

Identifiers

NCT01143220

JASMINE 0709

Details and patient eligibility

About

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.

Enrollment: 235 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

235 participants in 1 patient group

ICD / CRT-D patient

Description:

Patients implanted with a single or dual chamber ICD or CRT-D device approved in Japan capable of using the IBP feature.

Treatment:

Other: No specific interventions