UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002106 |
|---|---|
| Receipt number | 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 20:08:17 |
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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
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/
Sponsor or person
Institute
SATISFACTION Steering Committee
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002569
