UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004178 |
|---|---|
| Receipt number | 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 | 2024/11/18 09:38:08 |
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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
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
m-nomura@jll.co.jp
Sponsor or person
Institute
Sorin CRM SAS
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2009 | Year | 02 | Month | 01 | Day |
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
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005018
