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MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing (MORE-CRT MPP)

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ClinicalTrials.gov Identifier: NCT02006069
Recruitment Status : Active, not recruiting
First Posted : December 9, 2013
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE September 23, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date January 8, 2021
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
CRT Response [ Time Frame: Response to CRT after 6 months of MPP ]
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%.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
  • Reduction of LVESV in acute phase [ Time Frame: Baseline vs 6 Months ]
    Reduction of LVESV between baseline and 6 Months visit
  • Clinical Composite Score evaluation [ Time Frame: Baseline vs 12 Months ]
    Packer's Clinical Composite Score evaluation between baseline and 12 months and between 6 and 12 months
  • Reverse LV remodeling [ Time Frame: Baseline vs 12 Months ]
    Evaluation of Reverse LV remodeling, measured as changed in echo values LVESV, LVEDD and LVEF
  • NYHA Class changes [ Time Frame: Baseline vs 12 Months ]
    Evaluation of NYHA Class changes between Baseline and 12 Months FU
  • 6MWT changes [ Time Frame: Baseline vs 12 Months ]
    Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU
  • Patient's QoL score changes (MLWHF, EQ-5D) [ Time Frame: Baseline vs 12 Months ]
    Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) and EQ-5D Questionnaires
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing
Official Title  ICMJE MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)
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.
Detailed Description This study is designed as a prospective, randomized, multi-center trial. Data will be collected at enrollment, baseline, implant procedure, patient classification, 6 months and 12 months of follow-up. During the 6-month visit, the patient's response to CRT will be evaluated according to LVESV reduction. Patients with an LVESV reduction of at least 15% will be classified as responders. These patients will terminate their participation in the study and return to the center's standard practice. Patients with an LVESV reduction less than 15% will be classified as non-responders and the MPP feature will be activated according to randomization result and they will be followed until the 12-month visit.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: 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").

Study Arms  ICMJE
  • Experimental: MPP ON
    MPP ON: feature is enabled
    Intervention: Device: MPP
  • No Intervention: MPP OFF
    MPP OFF: feature not enabled
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2018)
6898
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2013)
1256
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   China,   Colombia,   Denmark,   Finland,   France,   Germany,   Greece,   India,   Israel,   Italy,   Korea, Republic of,   Lebanon,   Malaysia,   Malta,   Netherlands,   Poland,   Portugal,   Puerto Rico,   Saudi Arabia,   Singapore,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries South Africa
 
Administrative Information
NCT Number  ICMJE NCT02006069
Other Study ID Numbers  ICMJE CR-13-006-ID-HF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Christophe Leclercq Centre Cardio-Pneumologique, CHU Pontchaillou
PRS Account Abbott Medical Devices
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP