UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002304 |
|---|---|
| Receipt number | R000002812 |
| Scientific Title | Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy |
| Date of disclosure of the study information | 2009/08/06 |
| Last modified on | 2012/02/02 11:10:34 |
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Basic information
Public title
Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy
Acronym
Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy (OPTIMISE CRT)
Scientific Title
Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy
Scientific Title:Acronym
Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy (OPTIMISE CRT)
Region
| Japan | Asia(except Japan) | North America |
| Australia | Europe |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to demonstrate that frequent paced/sensed AV and V-V delay optimization using QuickOpt in patients with CRT-D device results in improved clinical response and structural remodeling over standard care (i.e. empiric programming or one-time optimization using any non-IEGM optimization methods).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A combination of symptomatic improvement (>=1 class reduction in specific activity scale (SAS) or >= 25% improvement in 6 minute walk test distance) and LV remodeling (>= 15% reduction LV end systolic volume or >= 5% improvement in LVEF)
Key secondary outcomes
1) Rate of late (12-month) response to CRT
2) Changes in B-type natriuretic peptide (BNP) in correlation to cardiac remodeling
3) Inter- / intra-ventricular dyssynchrony compared to usual optimization
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The paced / sensed AV and V-V delays will be optimized using QuickOpt. Optimization will be performed at enrollment, 3 month, 6 month, 9 month, 12 month and at any unscheduled follow-up visits.
Interventions/Control_2
The paced / sensed AV and V-V delays could be programmed empirically or optimized using any non-IEGM based method as per sites standard of care. Patients can be optimized only once within the first 4 weeks post implant.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient met standard CRT-D device indications (LVEF<= 35%, QRS >= 120 ms, NYHA Class III or ambulatory Class IV HF symptoms with optimal recommended medical therapy and at risk for sudden cardiac death or met the Japanese criteria for implantation of ICD) and was successfully implanted with an SJM CRT-D device with V-V timing and a compatible lead system.
2) Patient is willing to provide written informed consent.
3) Patient has the ability to complete a 6-minute hall walk test.
4) Patient is geographically stable and willing to comply with the required follow-up schedule.
5) Adequate echocardiographic images to measure LV end systolic volume will be available.
Key exclusion criteria
1) Patient has an epicardial ventricular lead system.
2) Patient has the ability to walk >= 450 meters in 6 minutes.
3) Patient has limited intrinsic atrial activity (<= 40 bpm).
4) Patient has persistent or permanent AF.
5) Patient has a second or third degree heart block.
6) Patient's life expectancy is less than 1 year
7) Patient is less than 18 years old.
8) Patient is pregnant.
9) Patient is on IV inotropic agents.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Morio Shoda |
Organization
Tokyo Women's Medical University Hospital
Division name
Cardiology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
St. Jude Medical Japan Co., Ltd
Division name
Clinical Affairs
Zip code
Address
Column Minami Aoyama, 3Flr., 7-1-5, Minami-Aoyama, Minato-ku, Tokyo Japan
TEL
03-5766-8215
Homepage URL
Sponsor or person
Institute
St. Jude Medical
Institute
Department
Personal name
Funding Source
Organization
St. Jude Medical Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Calgary (Derek Exner, MD)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00489177
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京女子医科大学病院（東京都）、他
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 06 | 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
Completed
Date of protocol fixation
| 2008 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 06 | Day |
Last modified on
| 2012 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002812
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