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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002106
Receipt No. R000002569
Scientific Title Survey on Antitachycardia Pacing Strategy for the Termination of Fast Ventricular Tachycardia in Japanese Implantable Cardioverter-Defibrillator Population
Date of disclosure of the study information 2009/06/23
Last modified on 2011/06/28

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Basic information
Public title Survey on Antitachycardia Pacing Strategy for the Termination of Fast Ventricular Tachycardia in Japanese Implantable Cardioverter-Defibrillator Population
Acronym The SATISFACTION Trial
Scientific Title Survey on Antitachycardia Pacing Strategy for the Termination of Fast Ventricular Tachycardia in Japanese Implantable Cardioverter-Defibrillator Population
Scientific Title:Acronym The SATISFACTION Trial
Region
Japan

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

Objectives
Narrative objectives1 To verify the benefit of ATP against Fast VT of patients in Japan with an implanted ICD or CRT-D device.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effects of first-time ATP treatment against Fast VT.
Key secondary outcomes -Effects of first-time ATP treatment in accordance to the underlying disease.
-Effects of first-time ATP treatment against Very Fast VT ( = 200ms < cycle length < 240ms: 251 - 300bpm, more rapid than Fast VT).
-Ratio of hazards according to patient background subgroups versus VT and VF event generation.

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 Patients implanted at domestic hospitals with an ICD or CRT-D device equipped with ATP During Charging or equivalent functionality.
Key exclusion criteria -Patient has not signed Informed Consent.
-Patient is less than 20 years of age.
-Patient is considered inadequate by a doctor for entry in this study (patient is unable to undergo enough follow-up, patient has limited life expectancy, patient has impaired mental status, etc.)

Target sample size 520

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Watanabe
Organization Kansai Rosai Hospital
Division name Department of Cardiology
Zip code
Address 3-1-69 Inaba-so Amagasaki-shi, Hyogo
TEL 06-6416-1221
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization SATISFACTION Steering Committee
Division name Kansai Rosai Hospital, Department of Cardiology
Zip code
Address 3-1-69 Inaba-so Amagasaki-shi, Hyogo
TEL 03-6430-7023
Homepage URL http://www.satisfaction-trial.org/
Email

Sponsor
Institute SATISFACTION Steering Committee
Institute
Department

Funding Source
Organization Association for Establishment of Evidence in Interventions
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 23 Day

Related information
URL releasing protocol http://www.satisfaction-trial.org
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 Open public recruiting
Date of protocol fixation
2009 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2010 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information - EGM recording required at follow-up.
- Check for episodes at follow-up.
- Episode data is recorded if episodes are confirmed.

Management information
Registered date
2009 Year 06 Month 23 Day
Last modified on
2011 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002569

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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