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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004178
Receipt No. R000005018
Scientific Title Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D implanted patients
Date of disclosure of the study information 2010/09/08
Last modified on 2016/09/12

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Basic information
Public title Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D implanted patients
Acronym The ASAP observational study
Scientific Title Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D implanted patients
Scientific Title:Acronym The ASAP observational study
Region
Japan North America Europe

Condition
Condition Patients implanted with an ICD or CRT-D device equipped with ATP Auto-switch function.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of the ATP Auto-switch towards ventricular arrhythmia reduction in PARADYM ICD & CRT-D implanted patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The primary objective of this observational study is to demonstrate that the efficacy rate* of the ATP Auto-switch function is at least equal to 85%.
Key secondary outcomes -Efficacy of ATP switch according to ICD programming and implant indication
-% ventricular pacing (%Vp) and incidence of V arrhythmias for each model
-Total Mortality and mortality related to cardio-vascular events

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Patient implanted with an ICD from SORIN Group
-ATP switch function programmed ON
-Patient has signed the informed consent for the use of her/his data
Key exclusion criteria -Presence of a contra-indication to the ICD therapy.
-Life expectancy less than 12 months.
-Inability or refusal to provide informed consent to the data treatment.
-Not available for routine follow-up visits.
-Minors and pregnant women.
Target sample size 1775

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Arnaud Savoure
Organization CHU Rouen
Division name Cardiology
Zip code
Address 1 rue de Germont, 76031 Rouen
TEL +33-2-32-88-89-90
Email m-nomura@jll.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenjiro Hara
Organization Japan Lifeline Co., Ltd.
Division name Cardiac Rhythm Management Marketing
Zip code
Address NYK Tennoz Bldg. 25F, 2-2-20, Higashishinagawa, Shinagawa-ku, Tokyo 140-0002
TEL 03-6711-5230
Homepage URL
Email m-nomura@jll.co.jp

Sponsor
Institute Sorin CRM SAS
Institute
Department

Funding Source
Organization Japan Lifeline Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01169246
Org. issuing International ID_1 clinicaltrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科歯科大学医学部附属病院
Tokyo Medical And Dental University Hospital Faculty of Medicine

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2009 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2014 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information -Multi-center and prospective study

In each follow-up:
-The medical and clinical data is collected in the case report forms.
-The electronic files containing device memory data is retrieved.

Management information
Registered date
2010 Year 09 Month 08 Day
Last modified on
2016 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005018

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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