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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02006069
Registration number
NCT02006069
Ethics application status
Date submitted
23/09/2013
Date registered
9/12/2013
Titles & IDs
Public title
MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing
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Scientific title
MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)
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Secondary ID [1]
0
0
CR-13-006-ID-HF
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Universal Trial Number (UTN)
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Trial acronym
MORE CRT MPP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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0
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Condition category
Condition code
Cardiovascular
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0
0
0
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Coronary heart disease
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Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - MPP
Experimental: MPP ON - MPP ON: feature is enabled
No intervention: MPP OFF - MPP OFF: feature not enabled
Treatment: Devices: MPP
All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device.
The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").
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Intervention code [1]
0
0
Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Non-responder Patients Who Converted to Responders
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Assessment method [1]
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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%.
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Timepoint [1]
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Non-responder to responder conversion rate between randomization at 6 months and 12 months
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Secondary outcome [1]
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Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase
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Assessment method [1]
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Reduction of LVESV between baseline and 6 Months visit
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Timepoint [1]
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Baseline vs 6 Months
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Secondary outcome [2]
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Clinical Composite Score Evaluation
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Assessment method [2]
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Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below,
* Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation
* Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation
* Unchanged: the patient was neither improved nor worsened
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Timepoint [2]
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Baseline vs 12 Months
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Secondary outcome [3]
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Reverse Left Ventricular (LV) Remodeling
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Assessment method [3]
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Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months
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Timepoint [3]
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Baseline vs 12 Months
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Secondary outcome [4]
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NYHA Class Changes
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Assessment method [4]
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Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.
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Timepoint [4]
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Baseline vs 12 Months
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Secondary outcome [5]
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6MWT Changes
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Assessment method [5]
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Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU
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Timepoint [5]
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Baseline vs 12 Months
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Secondary outcome [6]
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Patient's QoL Score Changes (MLWHF)
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Assessment method [6]
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Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life).
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Timepoint [6]
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Baseline vs 12 Months
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Eligibility
Key inclusion criteria
* Meets the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion 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
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/05/2021
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Sample size
Target
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Accrual to date
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Final
5850
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Flinders Medical Centre - Bedford Park
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St. Andrews War Memorial Hospital - Brisbane
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The Alfred Hospital - Melbourne
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Westmead Hospital - Westmead
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- Adelaide
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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- Brisbane
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- Melbourne
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- Westmead
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Funding & Sponsors
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Commercial sector/industry
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Name
Abbott Medical Devices
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02006069
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Trial related presentations / publications
Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Calo L, Vicentini A, Concha JF, Thibault B. Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I. Eur Heart J. 2019 Sep 14;40(35):2979-2987. doi: 10.1093/eurheartj/ehz109. Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Cohorn C, Thibault B; MORE-CRT MPP Investigators. Rationale and design of a randomized clinical trial to assess the safety and efficacy of multipoint pacing therapy: MOre REsponse on Cardiac Resynchronization Therapy with MultiPoint Pacing (MORE-CRT MPP-PHASE II). Am Heart J. 2019 Mar;209:1-8. doi: 10.1016/j.ahj.2018.12.004. Epub 2018 Dec 8.
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Public notes
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Contacts
Principal investigator
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Christophe Leclercq
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Centre Cardio-Pneumologique, CHU Pontchaillou
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/69/NCT02006069/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/69/NCT02006069/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02006069