Japanese Assessment of Indication Based Programming

NCT01143220 | Completed

• 1 other identifier: JASMINE 0709
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 45

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Degree of acceptance of IBP

  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.

Study Arms (1)

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

Interventions

No specific interventions OTHER

Observational investigation, only procedures according to local hospital standard.

ICD / CRT-D patient

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Guidant Corporation: collaborator

Study Sites (45)

Social Insurance Chukyo Hospital

Nagoya, Aichi-ken, 457-8510, Japan

Location

Hiraka General Hospital

Yokote, Akita, 013-8610, Japan

Location

Kameda Medical Hospital

Kamogawa, Chiba, 296-8602, Japan

Location

Shin-Tokyo Hospital

Matsudo, Chiba, 271-0077, Japan

Location

Juntendo University Urayasu Hospital

Urayasu, Chiba, 279-0021, Japan

Location

Saiseikai Imabari Hospital

Imabari, Ehime, 004-052, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Aso Iizuka Hospital

Iizuka, Fukuoka, 820-8505, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Shinkoga Hospital

Kurume, Fukuoka, 830-0033, Japan

Location

Shinsapporo Hospital of Cardiology

Sapporo, Hokkaido, 004-052, Japan

Location

Teine Keijinkai Hospital

Sapporo, Hokkaido, 006-8555, Japan

Location

Hokkaido Social Insurance Hospital

Sapporo, Hokkaido, 062-8618, Japan

Location

Hokkaido Medical Center

Sapporo, Hokkaido, 063-0005, Japan

Location

Hokko Memorial Hospital

Sapporo, Hokkaido, 065-0027, Japan

Location

Kanazawa Cardiovascular Hospital

Kanazawa, Ishikawa-ken, 920-0007, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, 259-1193, Japan

Location

Yokohama Rosai Hospital

Yokohama, Kanagawa, 222-0036, Japan

Location

Saiseikai Kumamoto Hospital

Kumamoto, Kumamoto, 861-4193, Japan

Location

Kumamoto Central Hospital

Kumamoto, Kumamoto, Japan

Location

Kyoto Katsura Hospital

Kyoto, Kyoto, 391-5811, Japan

Location

Kyoto Prefectual University of Medicine Hospital

Kyoto, Kyoto, 602-8566, Japan

Location

Uji Tokushukai Hospital

Uji, Kyoto, 004-052, Japan

Location

Yamada Red Cross Hospital

Ise, Mie-ken, 516-0805, Japan

Location

Matsumoto Kyoritsu Hospital

Matsumoto, Nagano, 390-8505, Japan

Location

Nagano Chuo Hospital

Nagano, Nagano, 380-0814, Japan

Location

Nagano Red Cross Hospital

Nagano, Nagano, 380-8582, Japan

Location

Niigata University Medical and Dental Hospital

Niigata, Niigata, 951-8520, Japan

Location

Sakurabashi Watanabe Hospital

Osaka, Osaka, 530-0001, Japan

Location

Iseikai Hospital

Osaka, Osaka, 533-0022, Japan

Location

Kinki University Hospital

Sayama, Osaka, 589-8511, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, 350-1298, Japan

Location

Hamamatsu Medical Center

Hamamatsu, Shizuoka, 432-8580, Japan

Location

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Location

Juntendo University Shizuoka Hospital

Izunokuni, Shizuoka, 410-2295, Japan

Location

Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

Juntendo University Hospital

Tokyo, Tokyo, 113-8431, Japan

Location

The University of Tokyo Hospital

Tokyo, Tokyo, 113-8655, Japan

Location

Tokyo Women's Medical University Medical Center East

Tokyo, Tokyo, 116-8567, Japan

Location

Tokyo Heart Center Osaki Hospital

Tokyo, Tokyo, 141-0001, Japan

Location

Toho University Ohashi Medical Center

Tokyo, Tokyo, 153-8515, Japan

Location

Keio University Hospital

Tokyo, Tokyo, 160-8582, Japan

Location

Ogikubo Hospital

Tokyo, Tokyo, 167-0035, Japan

Location

Yamaguchi Grand Medical Center

Hōfu, Yamaguchi, 747-8511, Japan

Location

Yamaguchi-ken Saiseikai Shimonoseki General Hospital

Shimonoseki, Yamaguchi, 759-6603, Japan

Location

MeSH Terms

Conditions

Heart Failure; Arrhythmias, Cardiac; Pathologic Processes; Heart Diseases; Tachycardia; Cardiovascular Diseases; Ventricular Flutter; Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 14, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

JP (45)