Unique ID issued by UMIN | UMIN000004178 |
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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 | 2016/09/12 14:42:59 |
Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D implanted patients
The ASAP observational study
Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D implanted patients
The ASAP observational study
Japan | North America | Europe |
Patients implanted with an ICD or CRT-D device equipped with ATP Auto-switch function.
Cardiology |
Others
NO
To investigate the efficacy of the ATP Auto-switch towards ventricular arrhythmia reduction in PARADYM ICD & CRT-D implanted patients.
Efficacy
Not applicable
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%.
-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
Observational
20 | years-old | <= |
Not applicable |
Male and Female
-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
-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.
1775
1st name | |
Middle name | |
Last name | Arnaud Savoure |
CHU Rouen
Cardiology
1 rue de Germont, 76031 Rouen
+33-2-32-88-89-90
m-nomura@jll.co.jp
1st name | |
Middle name | |
Last name | Kenjiro Hara |
Japan Lifeline Co., Ltd.
Cardiac Rhythm Management Marketing
NYK Tennoz Bldg. 25F, 2-2-20, Higashishinagawa, Shinagawa-ku, Tokyo 140-0002
03-6711-5230
m-nomura@jll.co.jp
Sorin CRM SAS
Japan Lifeline Co., Ltd.
Profit organization
Japan
YES
NCT01169246
clinicaltrials.gov
東京医科歯科大学医学部附属病院
Tokyo Medical And Dental University Hospital Faculty of Medicine
2010 | Year | 09 | Month | 08 | Day |
Unpublished
No longer recruiting
2009 | Year | 08 | Month | 24 | Day |
2009 | Year | 11 | Month | 01 | Day |
2014 | Year | 06 | Month | 01 | Day |
-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.
2010 | Year | 09 | Month | 08 | Day |
2016 | Year | 09 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005018
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