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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038661
Receipt No. R000044035
Scientific Title MORE-CRT MPP"MOre REsponse on Cardiac Resynchronization Therapy (CRT) with MultiPoint Pacing (MPP)"
Date of disclosure of the study information 2019/12/13
Last modified on 2020/05/08

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Basic information
Public title MORE-CRT MPP"MOre REsponse on Cardiac Resynchronization Therapy (CRT) with MultiPoint Pacing (MPP)"
Acronym MORE-CRT MPP
Scientific Title MORE-CRT MPP"MOre REsponse on Cardiac Resynchronization Therapy (CRT) with MultiPoint Pacing (MPP)"
Scientific Title:Acronym MORE-CRT MPP
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 purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.
Key secondary outcomes The secondary endpoints of this study are evaluated at 12 months after enrollment and are defined as

- Reduction of LVESV between baseline and 6 Months visit
- Packer s Clinical Composite Score evaluation between baseline and 12 Months visit and between 6 Months and 12 Months visits
- Reverse LV remodeling, measured as changes in LVESV, LVEDD and LVEF
- NYHA Class changes
- 6 minutes walking test changes
- Quality of Life (MLWHF and EQ-5D) changes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 "MPP ON Group"
Subjects with an LVESV reduction of less than 15% will be classified as NON RESPONDERS. The Randomization procedure assigns subjects to the Treatment Group (MPP ON) or Control Group (MPP OFF) in a 1:1 ratio.These subjects should be randomized and the device programmed to either MPP OFF or MPP ON per the randomization assignment.
Interventions/Control_2 "MPP OFF Group"
Subjects with an LVESV reduction of less than 15% will be classified as NON RESPONDERS. The Randomization procedure assigns subjects to the Treatment Group (MPP ON) or Control Group (MPP OFF) in a 1:1 ratio.These subjects should be randomized and the device programmed to either MPP OFF or MPP ON per the randomization assignment.
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 Eligible patients will meet ALL the following criteria:

- Meets the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant and the patients who are planned to be implanted study devices (including upgrades from single or dual chamber ICDs)
- Must be willing and able to comply with study requirements
- Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form
Key exclusion criteria Patients will be excluded if they meet ANY of the following criteria

- Already had a CRT device implanted
- Myocardial Infarction, unstable angina within 40 days prior the enrollment
- Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
- Primary valvular disease requiring surgical correction
- Atrial Fibrillation:
~ Persistent AF at the time of enrollment
~ Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant
~ History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
- Unable to comply with the follow up schedule
- Less than 18 years of age
- Pregnant or are planning to become pregnant during the duration of the investigation
- Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
- Undergone a cardiac transplantation
- Life expectancy < 12 months
- Currently participating in any other clinical investigation
Target sample size 6898

Research contact person
Name of lead principal investigator
1st name Heidi
Middle name
Last name Hindrichs
Organization Abbott
Division name Global Clinical and Regulatory Affairs
Zip code 91342
Address 15900 Valley View Court, Sylmar, CA91342, USA
TEL +1-818-493-3297
Email heidi.hinrichs@abbott.com

Public contact
Name of contact person
1st name Nikesha
Middle name N
Last name Harrington
Organization Abbott
Division name Clinical Affairs
Zip code 75024
Address 6901 Preston Rd., Plano, TX 75024, USA
TEL +1-972-526-4813
Homepage URL
Email nikesha.harrington@abbott.com

Sponsor
Institute Abbott
Institute
Department

Funding Source
Organization Abbott
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization USA

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Non-Profit Organization MINS Institutional Review Board
Address Mita 5-20-9-401, Minato-ku, Tokyo
Tel 03-6416-1868
Email http://www.npo-mins.com/

Secondary IDs
Secondary IDs YES
Study ID_1 ClinicalTrials.gov
Org. issuing International ID_1 NCT02006069
Study ID_2 jRCT
Org. issuing International ID_2 jRCT1032190138
IND to MHLW

Institutions
Institutions 信州大学(長野県)、福岡徳州会病院(福岡県)、聖マリアンナ医科大学(神奈川県)、国立循環器病研究センター(大阪府)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 13 Day

Related information
URL releasing protocol https://clinicaltrials.gov/ct2/show/NCT02006069
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 No longer recruiting
Date of protocol fixation
2018 Year 04 Month 09 Day
Date of IRB
2019 Year 07 Month 18 Day
Anticipated trial start date
2019 Year 12 Month 20 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 22 Day
Last modified on
2020 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044035

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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