UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005006 |
|---|---|
| Receipt number | R000005947 |
| Scientific Title | PainFree SST Clinical Study |
| Date of disclosure of the study information | 2011/02/03 |
| Last modified on | 2014/02/12 13:29:38 |
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Basic information
Public title
PainFree SST Clinical Study
Acronym
PainFree SST Clinical Study
Scientific Title
PainFree SST Clinical Study
Scientific Title:Acronym
PainFree SST Clinical Study
Region
| Japan | Asia(except Japan) | North America |
| South America | Europe |
Condition
Condition
Ventriculartachyarrhythmias
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the PainFree SST Clinical Study is to evaluate the rate of inappropriate
shocks at one year post implant in subjects implanted with a Protecta CRT-D/DR/VR
device. Due to differences between the Protecta CRT-D/DR and Protecta VR devices; the inappropriate shock-free rates of CRT-D/DR and VR devices will
be analyzed separately.
Additional objectives summarizing safety equivalence of VF NID programming in
secondary prevention patients, Quality of Life, Health Care Utilization, syncopal events
and reasons for inappropriate shocks will be analyzed. The objectives of the PainFree
SST Clinical Study are not intended to evaluate the long-term effects of the device and
its therapies. Medtronic will assess the long-term safety of these products through postmarket
surveillance.
Basic objectives2
Others
Basic objectives -Others
The purpose of the PainFree SST Clinical Study is to evaluate the rate of inappropriate
shocks at one year post implant in subjects implanted with a Protecta CRT-D/DR/VR
device.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary Objectives
- Evaluate the inappropriate shock free rate at one year post-implant for subjects
implanted with a DR-ICD or CRT-D device
- Evaluate the inappropriate shock free rate at one year post-implant for subjects
implanted with a VR-ICD device
Key secondary outcomes
Ancillary Objectives
- Demonstrate non-inferiority of syncopal event free rate of VF NID 30/40 versus
VF NID 18/24 in secondary prevention subjects
- Evaluate the effect of shocks on Quality of Life
- Evaluate the effect of shocks on Health Care Utilization
- Evaluate the frequency of full syncopal events
- Summarize the reasons for inappropriate shocks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Primary Prevention VF NID 30/40
Interventions/Control_2
Secondary Prevention VF NID 18/24
Interventions/Control_3
Secondary Prevention VF NID 30/40
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients meeting one of the following criteria can be included in Phase II of the study.
Subjects enrolled during Phase I of the study are automatically enrolled in Phase II of
the study.
- Patients indicated for a DR-ICD/VR-ICD/CRT-D device and intended to receive a
Protecta device
- Patients undergoing a DR-ICD/VR-ICD/CRT-D device replacement or an upgrade
to a Protecta DR-ICD/VR-ICD or CRT-D
 Patients indicated for a DR-ICD/VR-ICD/CRT-D already implanted with a Protecta
device and the protocol required leads, who have not yet been discharged after
implant
Patients must be indicated per local indications. Patients must be enrolled prior to or at
Pre-Hospital Discharge (PHD) and before any study procedures occur.
Key exclusion criteria
Patients meeting any of the following criteria cannot be included in the study
- Patients with a mechanical tricuspid heart valve
- Patients enrolled or intended to participate in any concurrent drug and/or device
study, which would confound the results of this trial as determined by Medtronic,
during the course of this clinical study
- Patients with medical conditions that preclude the testing required for all subjects
by the study protocol or that otherwise limit study participation required for all
subjects
- Patients with exclusion criteria required by local law (e.g. age, pregnancy, breast
feeding, etc)
- Patients anticipated not being able to complete the study
- Patients unwilling to provide written informed consent
Patients will be screened to ensure they meet all of the inclusion and none of the
exclusion criteria. Institutional Review Board / Medical Ethics Committee / Head of
Medical Institution / Helsinki Committee (Ethics Board) approval of the Protecta Clinical Investigation Plan and Informed Consent Form must be obtained prior to enrolling patients in the study.
Target sample size
181
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Laurence Sterns |
Organization
Royal Jubilee Hospital
Division name
Cardiology
Zip code
Address
Suite 335, 1900 Richmond Avenue Victoria, British Columbia Canada V8R 4R2
TEL
2505951551
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Tejima |
Organization
Medtronic Japan Co., Ltd.
Division name
CRDM Division Clinical
Zip code
Address
2-14-1 Higashi-Shimbashi, Minato-Ku, Tokyo, 105-0021
TEL
03-6430-7023
Homepage URL
http://www.medtronic.co.jp/
tomoyuki.tejima@medtronic.com
Sponsor or person
Institute
Medtronic Japan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
USA
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
NCT00982397
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
近畿大学医学部附属病院（大阪府）、京都大学医学部附属病院（京都府）、小倉記念病院（福岡県）、千葉大学医学部附属病院（千葉県）、国立循環器病研究センター（大阪府）等
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 02 | Day |
Last modified on
| 2014 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005947
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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