Japanese Assessment of Indication Based Programming (JASMINE)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Arrhythmias, Cardiac
• Intervention / Treatment: Other: No specific interventions

• Study Type: Observational
• Enrollment (Actual): 235

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Kumamoto, Japan, 861-4193
    • Saiseikai Kumamoto Hospital
  • Kumamoto, Japan
    • Kumamoto Central Hospital
  • Kyoto, Japan, 391-5811
    • Kyoto Katsura Hospital
  • Kyoto, Japan, 602-8566
    • Kyoto Prefectual University of Medicine Hospital
  • Nagano, Japan, 380-8582
    • Nagano Red Cross Hospital
  • Niigata, Japan, 951-8520
    • Niigata University Medical and Dental Hospital
  • Osaka, Japan, 530-0001
    • Sakurabashi Watanabe Hospital
  • Tokyo, Japan, 160-8582
    • Keio University Hospital
  • Tokyo, Japan, 167-0035
    • Ogikubo Hospital
  • Tokyo, Japan, 153-8515
    • Toho University Ohashi Medical Center
  • Tokyo, Japan, 113-8431
    • Juntendo University Hospital
  • Tokyo, Japan, 113-8655
    • The University of Tokyo Hospital
  • Tokyo, Japan, 116-8567
    • Tokyo Women's Medical University Medical Center East
  • Tokyo, Japan, 141-0001
    • Tokyo Heart Center Osaki Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 457-8510
      • Social Insurance Chukyo Hospital
  • Akita
    • Yokote, Akita, Japan, 013-8610
      • Hiraka General Hospital
  • Chiba
    • Kamogawa-city, Chiba, Japan, 296-8602
      • Kameda Medical Hospital
  • Chiba Prefecture
    • Urayasu, Chiba Prefecture, Japan, 279-0021
      • Juntendo University Urayasu Hospital
  • Chiba-Prefecture
    • Matsudo-city, Chiba-Prefecture, Japan, 271-0077
      • Shin-Tokyo Hospital
  • Ehime
    • Imabari, Ehime, Japan, 004-052
      • Saiseikai Imabari Hospital
  • Fukuoka
    • Iizuka, Fukuoka, Japan, 820-8505
      • Aso Iizuka Hospital
    • Kitakyusyu, Fukuoka, Japan, 802-8555
      • Kokura Memorial Hospital
    • Kurume, Fukuoka, Japan, 830-0033
      • Shinkoga Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 006-8555
      • Teine Keijinkai Hospital
    • Sapporo, Hokkaido, Japan, 004-052
      • Shinsapporo Hospital of Cardiology
    • Sapporo, Hokkaido, Japan, 062-8618
      • Hokkaido Social Insurance Hospital
    • Sapporo, Hokkaido, Japan, 063-0005
      • Hokkaido Medical Center
    • Sapporo, Hokkaido, Japan, 065-0027
      • Hokko Memorial Hospital
  • Ishikawa
    • Kanazawa-City, Ishikawa, Japan, 920-0007
      • Kanazawa Cardiovascular Hospital
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Tokai University Hospital
    • Yokohama, Kanagawa, Japan, 222-0036
      • Yokohama Rosai Hospital
  • Kyoto
    • Uji, Kyoto, Japan, 004-052
      • Uji Tokushukai Hospital
  • Mie
    • Ise, Mie, Japan, 516-0805
      • Yamada Red Cross Hospital
  • Nagano
    • Matsumoto City, Nagano, Japan, 390-8505
      • Matsumoto Kyoritsu Hospital
  • Nagano Prefecture
    • Nagano-city, Nagano Prefecture, Japan, 380-0814
      • Nagano Chuo Hospital
  • Osaka
    • Osaka-city, Osaka, Japan, 533-0022
      • Iseikai Hospital
    • Osakasayama-city, Osaka, Japan, 589-8511
      • Kinki University Hospital
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Saitama Medical University International Medical Center
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 432-8580
      • Hamamatsu Medical Center
    • Hamamatsu City, Shizuoka, Japan
      • Seirei Hamamatsu General Hospital
    • Izunokuni, Shizuoka, Japan, 410-2295
      • Juntendo University Shizuoka Hospital
  • Tochigi
    • Shimotsuga-gun, Tochigi, Japan, 321-0293
      • Dokkyo Medical University Hospital
  • Yamaguchi
    • Hofu-city, Yamaguchi, Japan, 747-8511
      • Yamaguchi Grand Medical Center
    • Shimonoseki, Yamaguchi, Japan, 759-6603
      • Yamaguchi-ken Saiseikai Shimonoseki General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No specific interventions; Observational investigation, only procedures according to local hospital standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: Guidant Corporation

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 11, 2010
• First Submitted That Met QC Criteria: June 11, 2010
• First Posted (Estimate): June 14, 2010

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Heart Failure; Pathologic Processes; Cardiovascular Diseases; Cardiac Resynchronization Therapy; Heart Diseases; Tachycardia; Ease of Use; Arrhythmias, Cardiac; Ventricular Fibrillation; Ventricular Flutter; Tachycardia, Ventricular
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Heart Failure; Arrhythmias, Cardiac
• Other Study ID Numbers: JASMINE 0709