Heart FailureJASMINENCT01143220
Japanese Assessment of Indication Based Programming
An observational study of Heart Failure and Arrhythmias, Cardiac, run by Boston Scientific Corporation at 45 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, Arrhythmias, Cardiac
- What is being tested?
- No specific interventions
- How many people
- 235 participants
- Where
- 45 sitesJapan
- Study dates
- Aug 2010to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
45 sites in 1 country.
45 sites in 1 country
Japan45 sites
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Hamamatsu Medical Center
Hamamatsu, Shizuoka, 432-8580
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
Yamaguchi Grand Medical Center
Hōfu, Yamaguchi, 747-8511
Aso Iizuka Hospital
Iizuka, Fukuoka, 820-8505
Saiseikai Imabari Hospital
Imabari, Ehime, 004-052
Yamada Red Cross Hospital
Ise, Mie-ken, 516-0805
Tokai University Hospital
Isehara, Kanagawa, 259-1193
Juntendo University Shizuoka Hospital
Izunokuni, Shizuoka, 410-2295
Kameda Medical Hospital
Kamogawa, Chiba, 296-8602
Kanazawa Cardiovascular Hospital
Kanazawa, Ishikawa-ken, 920-0007
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193
Kumamoto Central Hospital
Kumamoto, Kumamoto
Shinkoga Hospital
Kurume, Fukuoka, 830-0033
Kyoto Katsura Hospital
Kyoto, Kyoto, 391-5811
Kyoto Prefectual University of Medicine Hospital
Kyoto, Kyoto, 602-8566
Shin-Tokyo Hospital
Matsudo, Chiba, 271-0077
Matsumoto Kyoritsu Hospital
Matsumoto, Nagano, 390-8505
Nagano Chuo Hospital
Nagano, Nagano, 380-0814
Nagano Red Cross Hospital
Nagano, Nagano, 380-8582
Social Insurance Chukyo Hospital
Nagoya, Aichi-ken, 457-8510
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520
Sakurabashi Watanabe Hospital
Osaka, Osaka, 530-0001
Iseikai Hospital
Osaka, Osaka, 533-0022
Shinsapporo Hospital of Cardiology
Sapporo, Hokkaido, 004-052
Teine Keijinkai Hospital
Sapporo, Hokkaido, 006-8555
Hokkaido Social Insurance Hospital
Sapporo, Hokkaido, 062-8618
Hokkaido Medical Center
Sapporo, Hokkaido, 063-0005
Hokko Memorial Hospital
Sapporo, Hokkaido, 065-0027
Kinki University Hospital
Sayama, Osaka, 589-8511
Yamaguchi-ken Saiseikai Shimonoseki General Hospital
Shimonoseki, Yamaguchi, 759-6603
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, 321-0293
Juntendo University Hospital
Tokyo, Tokyo, 113-8431
The University of Tokyo Hospital
Tokyo, Tokyo, 113-8655
Tokyo Women's Medical University Medical Center East
Tokyo, Tokyo, 116-8567
Tokyo Heart Center Osaki Hospital
Tokyo, Tokyo, 141-0001
Toho University Ohashi Medical Center
Tokyo, Tokyo, 153-8515
Keio University Hospital
Tokyo, Tokyo, 160-8582
Ogikubo Hospital
Tokyo, Tokyo, 167-0035
Uji Tokushukai Hospital
Uji, Kyoto, 004-052
Juntendo University Urayasu Hospital
Urayasu, Chiba, 279-0021
Yokohama Rosai Hospital
Yokohama, Kanagawa, 222-0036
Hiraka General Hospital
Yokote, Akita, 013-8610
About this study
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.
- Conditions
- Heart Failure, Arrhythmias, Cardiac
- Being tested
- No specific interventions
- Keywords
- Cardiac Resynchronization Therapy, Heart Failure, Pathologic Processes, Heart Diseases, Tachycardia, Cardiovascular Diseases, Ventricular Flutter, Tachycardia, Ventricular, Ventricular Fibrillation, Arrhythmias, Cardiac, Ease of Use
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac, Pathologic Processes, Heart Diseases, Tachycardia, Cardiovascular Diseases, Ventricular Flutter, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No specific interventionsOther
Observational investigation, only procedures according to local hospital standard.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No specific interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment / Last available follow up during the first six months after implant
Secondary outcomes (13)
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.
Measured: Enrollment / Last available follow up during the first six months after implant
Proportion of patients without any IBP use
Measured: First six months after implant.
Proportion of patients without any IBP use at enrollment, but IBP use during follow up.
Measured: First six months after implant.
Proportion of patients with IBP use only at enrollment.
Measured: First six months after implant.
oProportion of patients with IBP use during enrollment and additional subsequent use of IBP during follow up.
Measured: First six months after implant.
Proportion of parameters changed per patient from nominal device settings.
Measured: First six months after implant.
Proportion of parameters changed per patient from IBP recommended device settings, if IBP was used.
Measured: First six months after implant.
Differences between nominal parameters and final programming by physicians for parameters with quantitative values.
Measured: First six months after implant.
Differences between parameters recommended by IBP and final programming by physicians for parameters with quantitative values
Measured: First six months after implant.
Total number of parameter changes recorded during the enrollment procedure after IBP recommendations were programmed.
Measured: First six months after implant.
Total number of parameter changes to a value different from the device nominals recorded during the enrollment procedure
Measured: First six months after implant.
oTotal number of parameter changes during follow up procedure(s)
Measured: First six months after implant.
Frequency of changes made to a single parameter during the time the patient is enrolled in the clinical investigation.
Measured: First six months after implant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guidant Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143220
- Sponsor's protocol ID
- JASMINE 0709
- Acronym
- JASMINE
- Status last verified
- Feb 2017
- First submitted
- 11 Jun 2010
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japanese Assessment of Indication Based Programming
- ClinicalTrials.gov ID
- NCT01143220
- Acronym / sponsor ID
- JASMINE / JASMINE 0709
- Conditions
- Heart Failure, Arrhythmias, Cardiac
- Keywords
- Cardiac Resynchronization Therapy, Heart Failure, Pathologic Processes, Heart Diseases, Tachycardia, Cardiovascular Diseases, Ventricular Flutter, Tachycardia, Ventricular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Guidant Corporation
- Study start
- Aug 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD / CRT-D patient | – | Other: No specific interventionsPatients implanted with a single or dual chamber ICD or CRT-D device approved in Japan capable of using the IBP feature. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No specific interventionsObservational investigation, only procedures according to local hospital standard. | Other | ICD / CRT-D patient |
Primary outcome
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.
13 secondary outcomes
Degree of acceptance of IBP
Time frame: Enrollment / Last available follow up during the first six months after implant
Proportion of patients without any IBP use
Time frame: First six months after implant.
Proportion of patients without any IBP use at enrollment, but IBP use during follow up.
Time frame: First six months after implant.
Proportion of patients with IBP use only at enrollment.
Time frame: First six months after implant.
oProportion of patients with IBP use during enrollment and additional subsequent use of IBP during follow up.
Time frame: First six months after implant.
Proportion of parameters changed per patient from nominal device settings.
Time frame: First six months after implant.
Proportion of parameters changed per patient from IBP recommended device settings, if IBP was used.
Time frame: First six months after implant.
Differences between nominal parameters and final programming by physicians for parameters with quantitative values.
Time frame: First six months after implant.
Differences between parameters recommended by IBP and final programming by physicians for parameters with quantitative values
Time frame: First six months after implant.
Total number of parameter changes recorded during the enrollment procedure after IBP recommendations were programmed.
Time frame: First six months after implant.
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.
oTotal number of parameter changes during follow up procedure(s)
Time frame: First six months after implant.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
Related trials for Heart Failure
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Recruiting
Evaluation of the Effects of Sauna Therapy on Congestion and Loop Diuretic Use in Patients With Heart Failure With Reduced or Moderately Reduced Ejection Fraction
Heart Failure
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Enrolling by invitation
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Heart Failure, Transplant; Failure, Heart
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Arrhythmias, Cardiac, run by Boston Scientific Corporation at 45 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.