MPP Narrow QRS:Pilot Study on Multipoint Pacing in Patients With QRS Beetwen 100 and 130 Msec

Study Overview
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Brief Summary
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The purpose of this study is to assess the impact of the Multi Point Pacing (MPP) feature in the treatment of patients with QRS beetwen 100 and 130 msec in patients candidate to ICD implant.

Official Title
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MPP Narrow QRS:Pilot Study on Multipoint Pacing in Patients With Narrow QRS

Conditions
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Heart Failure

Intervention / Treatment
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* Device: MultiPoint Pacing ON
* Device: Implantable cardioverter-defibrillator (ICD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with EF < 35% on OPT at least 3 months and candidate to ICD QRS duration: 100-130 ms Patients 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 Successful quadripolar LV lead implant (only for Treatment Group) Exclusion Criteria: Myocardial Infarction, unstable angina within 40 days prior the enrollment Patients with no left ventricular contractile reserve after low dose dobutamine stress echocardiography test 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 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 Patients with permanent Atrial fibrillation Patients with Nyha 1

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MPP ON<br>Patients will be randomized to the MPP-ON Arm vs Standard ICD | Device: MultiPoint Pacing ON<br>* MultiPoint Pacing ON<br>|
| Active Comparator: Standard ICD<br>Patients will be randomized to the MPP-ON Arm vs Standard ICD | Device: Implantable cardioverter-defibrillator (ICD)<br>* Implantable cardioverter-defibrillator (ICD)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 6 and 12 months |  | up to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients presenting reverse remodeling (reduction of ESV > 15%) after 24 months |  | 24-Months | 
| Percentage of responder patients in term of increase of EF > 5 points % at 12 months Follow-Up |  | 12-Months | 
| Percentage of responder patients in term of increase of EF > 5 points % at 24 months Follow-Up |  | 24-Months | 
| Percentage of responder patients in term of BNP < 400 pg/ml at 12 months |  | 12 Months |