MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing

Study Overview
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Brief Summary
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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
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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.

Official Title
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MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)

Conditions
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Heart Failure

Intervention / Treatment
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* Device: MPP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPP ON<br>MPP ON: feature is enabled | Device: MPP<br>* 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).<br>|
| No Intervention: MPP OFF<br>MPP OFF: feature not enabled | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Non-responder Patients Who Converted to Responders | 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%. | Non-responder to responder conversion rate between randomization at 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase | Reduction of LVESV between baseline and 6 Months visit | Baseline vs 6 Months | 
| Clinical Composite Score Evaluation | Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below, Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation Unchanged: the patient was neither improved nor worsened | Baseline vs 12 Months | 
| Reverse Left Ventricular (LV) Remodeling | Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months | Baseline vs 12 Months | 
| NYHA Class Changes | Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization. | Baseline vs 12 Months | 
| 6MWT Changes | Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU | Baseline vs 12 Months | 
| Patient's QoL Score Changes (MLWHF) | Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life). | Baseline vs 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRT, non responders, MultiPoint Pacing (MPP)