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Completed

NCT Number: NCT01143220

Japanese Assessment of Indication Based Programming

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.

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Fibrillation Ventricular Flutter

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Social Insurance Chukyo Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No specific interventions

Other

Observational investigation, only procedures according to local hospital standard.

Primary outcomes

  1. 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

    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 outcomes

  1. Degree of acceptance of IBP

    Time frame: 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.

  2. Proportion of patients without any IBP use

    Time frame: First six months after implant.

  3. Proportion of patients without any IBP use at enrollment, but IBP use during follow up.

    Time frame: First six months after implant.

  4. Proportion of patients with IBP use only at enrollment.

    Time frame: First six months after implant.

  5. oProportion of patients with IBP use during enrollment and additional subsequent use of IBP during follow up.

    Time frame: First six months after implant.

  6. Proportion of parameters changed per patient from nominal device settings.

    Time frame: First six months after implant.

  7. Proportion of parameters changed per patient from IBP recommended device settings, if IBP was used.

    Time frame: First six months after implant.

  8. Differences between nominal parameters and final programming by physicians for parameters with quantitative values.

    Time frame: First six months after implant.

  9. Differences between parameters recommended by IBP and final programming by physicians for parameters with quantitative values

    Time frame: First six months after implant.

  10. Total number of parameter changes recorded during the enrollment procedure after IBP recommendations were programmed.

    Time frame: First six months after implant.

  11. 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.

  12. oTotal number of parameter changes during follow up procedure(s)

    Time frame: First six months after implant.

  13. 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • Guidant Corporation

Registry information

Acronym: JASMINE

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 14, 2010
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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