UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038661 |
|---|---|
| Receipt number | 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 | 2022/05/25 16:46:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
nikesha.harrington@abbott.com
Sponsor or person
Institute
Abbott
Institute
Department
Personal name
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
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
Terminated
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
| 2021 | Year | 05 | Month | 30 | 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
| 2022 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.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 |
