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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: MPP Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6898 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)
Study Start Date : December 2013
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: MPP ON
MPP ON: feature is enabled
 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").
No Intervention: MPP OFF
MPP OFF: feature not enabled


Outcome Measures
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Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. Reduction of LVESV in acute phase [ Time Frame: Baseline vs 6 Months ]
    Reduction of LVESV between baseline and 6 Months visit

  2. 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

  3. Reverse LV remodeling [ Time Frame: Baseline vs 12 Months ]
    Evaluation of Reverse LV remodeling, measured as changed in echo values LVESV, LVEDD and LVEF

  4. NYHA Class changes [ Time Frame: Baseline vs 12 Months ]
    Evaluation of NYHA Class changes between Baseline and 12 Months FU

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006069


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Chair: Christophe Leclercq Centre Cardio-Pneumologique, CHU Pontchaillou
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02006069    
Other Study ID Numbers: CR-13-006-ID-HF
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abbott Medical Devices:
CRT, non responders, MultiPoint Pacing (MPP)
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases