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 2016/09/12 14:42:59

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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 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


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

Value
https://center6.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