MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing (MORE-CRT MPP)
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|ClinicalTrials.gov Identifier: NCT02006069|
Recruitment Status : Recruiting
First Posted : December 9, 2013
Last Update Posted : November 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: MPP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6898 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Experimental: MPP ON
MPP ON: feature is enabled
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
- 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
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
|Contact: Nikesha Harringtonemail@example.com|
|Study Chair:||Christophe Leclercq||Centre Cardio-Pneumologique, CHU Pontchaillou|