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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
Scientific title
MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)
Secondary ID [1] 0 0
CR-13-006-ID-HF
Universal Trial Number (UTN)
Trial acronym
MORE CRT MPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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").
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Non-responder Patients Who Converted to Responders
Timepoint [1] 0 0
Non-responder to responder conversion rate between randomization at 6 months and 12 months
Secondary outcome [1] 0 0
Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase
Timepoint [1] 0 0
Baseline vs 6 Months
Secondary outcome [2] 0 0
Clinical Composite Score Evaluation
Timepoint [2] 0 0
Baseline vs 12 Months
Secondary outcome [3] 0 0
Reverse Left Ventricular (LV) Remodeling
Timepoint [3] 0 0
Baseline vs 12 Months
Secondary outcome [4] 0 0
NYHA Class Changes
Timepoint [4] 0 0
Baseline vs 12 Months
Secondary outcome [5] 0 0
6MWT Changes
Timepoint [5] 0 0
Baseline vs 12 Months
Secondary outcome [6] 0 0
Patient's QoL Score Changes (MLWHF)
Timepoint [6] 0 0
Baseline vs 12 Months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/05/2021
Sample size
Target
Accrual to date
Final
5850
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
St. Andrews War Memorial Hospital - Brisbane
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Westmead
Recruitment outside Australia
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United States of America
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christophe Leclercq
Address 0 0
Centre Cardio-Pneumologique, CHU Pontchaillou
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02006069