UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009660 |
|---|---|
| Receipt number | R000011039 |
| Scientific Title | A Prospective Non-randomized Multicenter Study to Demonstrate the Clinical Validity of the Intracardiac Impedance (ICI) Measurements by Comparing the ICI Values with Clinical Markers which are Relevant for Efficient Therapy Management of Heart Failure Patient |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2015/07/08 17:17:07 |
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Basic information
Public title
A Prospective Non-randomized Multicenter Study to Demonstrate the Clinical Validity of the Intracardiac Impedance (ICI) Measurements by Comparing the ICI Values with Clinical Markers which are Relevant for Efficient Therapy Management of Heart Failure Patient
Acronym
DETECT-ICI
Scientific Title
A Prospective Non-randomized Multicenter Study to Demonstrate the Clinical Validity of the Intracardiac Impedance (ICI) Measurements by Comparing the ICI Values with Clinical Markers which are Relevant for Efficient Therapy Management of Heart Failure Patient
Scientific Title:Acronym
DETECT-ICI
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the study is to demonstrate the clinical validity of the Intracardiac Impedance (ICI) measurements by comparing the ICI values with clinical markers which are relevant for an fficient therapy management of heart failure patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The purpose of the primary endpoint 1 is the evaluation of the correlation between the end-systolic impedance (ESZ) assessed by the intracardiac impedance measurement and the left ventricular end-systolic volume (LVESV) assessed by echo 2 dimensional biplane Simpson's method.
Key secondary outcomes
*Identification of a predictive signal pattern of the intracardiac impedance for acute decompensation of heart failure
*Evaluate the correlation between intracardiac impedance and the expected 1-year survival period calculated by the Seattle Heart Failure score
*Evaluate the correlation between stroke impedance assessed by the intracardiac impedance measurement and stroke volume assessed by echocardiography
*Evaluate the correlation between stroke impedance assessed by the intracardiac impedance measurement and the blood concentration of the natriuretic peptide BNP
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 signed patient informed consent form.
*Patient has a standard indication for CRT-D therapy.
*Patient is implanted a new bipolar LV lead with a tip ring distance of at least *Patient is implanted a true bipolar RV shock lead
*Patient accepts Home Monitoring concept and has sufficient 3 G/L-LINE net
*Patient is able to attend to the planned *Patient has legal capacity and ability to consent.
Key exclusion criteria
*Patient has a standard contraindication for CRT-D implantation.
*Permanent AF and contraindication to be programmed to non-DDD mode (DDI or VVI)
*Patient suffering from aortic valve stenosis, severe aortic insufficiency, or aortic valve prosthesis
*Age < 20 years
*Pregnant or breast-feeding woman
*Cardiac surgery within previous 3 months or planned at time of inclusion
*Life expectancy of less than 12 months due to any condition
*Chronic renal dialysis
*Participating in a clinical study of an investigational cardiac drug or device that includes an active treatment arm
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morio Shoda |
Organization
Tokyo Women's Medical University
Division name
Department of Cardiology
Zip code
Address
8-1 Kawata-cho, Shinjuku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuomi Tanaka |
Organization
Biotronik Japan
Division name
Clinical Affairs
Zip code
Address
TEL
03-3473-7478
Homepage URL
Sponsor or person
Institute
Biotronik Japan
Institute
Department
Personal name
Funding Source
Organization
Biotronik Japan
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 01 | Month | 01 | 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
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 31 | Day |
Other
Other related information
Measurement of intracardiac impedance
Management information
Registered date
| 2012 | Year | 12 | Month | 28 | Day |
Last modified on
| 2015 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011039
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