Trial from ClinicalTrials.gov

For full trial details, please see the original record at



Trial ID
NCT02006069
Ethics application status
Date submitted
23/09/2013
Date registered
23/09/2013
Date last updated
10/10/2017

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
CRT Response - 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%.
Timepoint [1] 0 0
Response to CRT after 6 months of MPP
Secondary outcome [1] 0 0
Reduction of LVESV in acute phase - Reduction of LVESV between baseline and 6 Months visit
Timepoint [1] 0 0
Baseline vs 6 Months
Secondary outcome [2] 0 0
Clinical Composite Score evaluation - Packer's Clinical Composite Score evaluation between baseline and 12 months and between 6 and 12 months
Timepoint [2] 0 0
Baseline vs 12 Months
Secondary outcome [3] 0 0
Reverse LV remodeling - Evaluation of Reverse LV remodeling, measured as changed in echo values LVESV, LVEDD and LVEF
Timepoint [3] 0 0
Baseline vs 12 Months
Secondary outcome [4] 0 0
NYHA Class changes - Evaluation of NYHA Class changes between Baseline and 12 Months FU
Timepoint [4] 0 0
Baseline vs 12 Months
Secondary outcome [5] 0 0
6MWT changes - Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU
Timepoint [5] 0 0
Baseline vs 12 Months
Secondary outcome [6] 0 0
Patient's QoL score changes (MLWHF, EQ-5D) - Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) and EQ-5D Questionnaires
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
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Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
St. Andrews War Memorial Hospital - Brisbane
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
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- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment outside Australia
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Austria
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St. Poelten
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Gilly
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Canada
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Calgary
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Edmonton
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Halifax
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Kingston
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Montreal
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Montréal
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Sainte-Foy
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St. Johns
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Toronto
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Vancouver
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Victoria
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Hong Kong
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Colombia
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Cali
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Colombia
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Medellín
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Denmark
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Fyn
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Denmark
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Nordjylland
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Denmark
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Aarhus
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Finland
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Jyvaskyla
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Finland
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Turku
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Alpes
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Brest
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Lille
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Lomme
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Marseille
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Montbéliard
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Montpellier
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Nancy
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Nantes
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Paris
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Rennes
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Rouen
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Valence
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Villeurbanne
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Germany
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Baden-Wurttemberg
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Baden-Württemberg
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Hessen
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Niedersachsen
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Nordrhein-Westfalen
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Bad Oeynhausen
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Bad Rothenfelde
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Berlin
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Bielefeld
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Bochum
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Coburg
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Erfurt
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Essen
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Hamburg
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Heidelberg
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Ingolstadt
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Köln
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Leipzig
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Ludenscheid
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Lünen
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Muenster
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München
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Oldenburg
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Osnabrück
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Trier
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Villingen-Schwenningen
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Würzburg
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Greece
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Athens
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Haryana
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India
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Ahmedabad
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India
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Chandigarh
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India
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India
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Roma
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Rome
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Italy
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San Fermo della Battaglia
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San Giovanni Rotondo
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Verona
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Gangnam-gu
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Paola
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Eindhoven
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Enschede
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Zwolle
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Slaskie
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Slask
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Braga
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Lisbon
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Ponce
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San Juan
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Riyadh
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Singapore
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Singapore
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South Africa
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Sunninghill
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Spain
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A Coruña
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Badajoz
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Spain
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Barcelona
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Granada
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Pamplona
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Spain
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Valencia
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Spain
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Vigo
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Spain
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Zaragoza
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Sweden
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Stockholm
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Switzerland
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Geneva
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Taipei
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United Kingdom
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Birmingham
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United Kingdom
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Brighton
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Oxford
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United Kingdom
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Southampton
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United Kingdom
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Swindon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
St. Jude Medical
Address
Country

Ethics approval
Ethics application status

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.
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
Michael Boogmans
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
mboogmans@sjm.com
Contact person for scientific queries
Contact person responsible for updating information