Clinical trial NCT01143220: Japanese Assessment of Indication Based Programming
Official title: Japanese Assessment of Indication Based Programming
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Arrhythmias, Cardiac
Keywords: Cardiac Resynchronization Therapy
Heart Failure
Pathologic Processes
Heart Diseases
Tachycardia
Cardiovascular Diseases
Ventricular Flutter
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Ease of Use
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Guidant Corporation
First posted: 2010-06-14
Enrollment: 235
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients that are programmed by the physician to anything other than the specific IBP parameter settings
timeFrame: Enrollment / Last available follow up during the first six months after implant
Secondary outcomes:
measure: Degree of acceptance of IBP
timeFrame: Enrollment / Last available follow up during the first six months after implant
measure: Proportion of patients without any IBP use
timeFrame: First six months after implant.
measure: Proportion of patients without any IBP use at enrollment, but IBP use during follow up.
timeFrame: First six months after implant.
measure: Proportion of patients with IBP use only at enrollment.
timeFrame: First six months after implant.
measure: oProportion of patients with IBP use during enrollment and additional subsequent use of IBP during follow up.
timeFrame: First six months after implant.
measure: Proportion of parameters changed per patient from nominal device settings.
timeFrame: First six months after implant.
measure: Proportion of parameters changed per patient from IBP recommended device settings, if IBP was used.
timeFrame: First six months after implant.
measure: Differences between nominal parameters and final programming by physicians for parameters with quantitative values.
timeFrame: First six months after implant.
measure: Differences between parameters recommended by IBP and final programming by physicians for parameters with quantitative values
timeFrame: First six months after implant.
measure: Total number of parameter changes recorded during the enrollment procedure after IBP recommendations were programmed.
timeFrame: First six months after implant.
measure: Total number of parameter changes to a value different from the device nominals recorded during the enrollment procedure
timeFrame: First six months after implant.
measure: oTotal number of parameter changes during follow up procedure(s)
timeFrame: First six months after implant.
measure: Frequency of changes made to a single parameter during the time the patient is enrolled in the clinical investigation.
timeFrame: First six months after implant.
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Social Insurance Chukyo Hospital
state: Aichi
city: Yokote
country: Japan
facility: Hiraka General Hospital
state: Akita
city: Urayasu
country: Japan
facility: Juntendo University Urayasu Hospital
state: Chiba Prefecture
city: Matsudo-city
country: Japan
facility: Shin-Tokyo Hospital
state: Chiba-Prefecture
city: Kamogawa-city
country: Japan
facility: Kameda Medical Hospital
state: Chiba
city: Imabari
country: Japan
facility: Saiseikai Imabari Hospital
state: Ehime
city: Iizuka
country: Japan
facility: Aso Iizuka Hospital
state: Fukuoka
city: Kitakyusyu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: Shinkoga Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Shinsapporo Hospital of Cardiology
state: Hokkaido
city: Sapporo
country: Japan
facility: Teine Keijinkai Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Social Insurance Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido Medical Center
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokko Memorial Hospital
state: Hokkaido
city: Kanazawa-City
country: Japan
facility: Kanazawa Cardiovascular Hospital
state: Ishikawa
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Rosai Hospital
state: Kanagawa
city: Uji
country: Japan
facility: Uji Tokushukai Hospital
state: Kyoto
city: Ise
country: Japan
facility: Yamada Red Cross Hospital
state: Mie
city: Nagano-city
country: Japan
facility: Nagano Chuo Hospital
state: Nagano Prefecture
city: Matsumoto City
country: Japan
facility: Matsumoto Kyoritsu Hospital
state: Nagano
city: Osaka-city
country: Japan
facility: Iseikai Hospital
state: Osaka
city: Osakasayama-city
country: Japan
facility: Kinki University Hospital
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Hamamatsu City
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Hamamatsu
country: Japan
facility: Hamamatsu Medical Center
state: Shizuoka
city: Izunokuni
country: Japan
facility: Juntendo University Shizuoka Hospital
state: Shizuoka
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Hofu-city
country: Japan
facility: Yamaguchi Grand Medical Center
state: Yamaguchi
city: Shimonoseki
country: Japan
facility: Yamaguchi-ken Saiseikai Shimonoseki General Hospital
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Central Hospital
city: Kyoto
country: Japan
facility: Kyoto Katsura Hospital
city: Kyoto
country: Japan
facility: Kyoto Prefectual University of Medicine Hospital
city: Nagano
country: Japan
facility: Nagano Red Cross Hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: The University of Tokyo Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Medical Center East
city: Tokyo
country: Japan
facility: Tokyo Heart Center Osaki Hospital
city: Tokyo
country: Japan
facility: Toho University Ohashi Medical Center
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Ogikubo Hospital
Study officials:
References: