MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing (MORE-CRT MPP)
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ClinicalTrials.gov Identifier: NCT02006069 |
Recruitment Status :
Terminated
(The steering committee had decided to discontinue enrollment because the interim analysis showed a low probability that the study would meet the primary endpoint. The interim analysis did not demonstrate any safety concerns with activating MPP.)
First Posted : December 9, 2013
Last Update Posted : November 5, 2021
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Condition or disease | Intervention/treatment | Phase |
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Heart Failure | Device: MPP | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5850 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 |
Actual Primary Completion Date : | May 30, 2021 |
Actual Study Completion Date : | May 30, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: MPP ON
MPP ON: feature is enabled
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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
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- 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%.
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

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

Study Chair: | Christophe Leclercq | Centre Cardio-Pneumologique, CHU Pontchaillou |
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: | November 5, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
CRT, non responders, MultiPoint Pacing (MPP) |
Heart Failure Heart Diseases Cardiovascular Diseases |