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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002304
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute St. Jude Medical
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002812

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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