More Response on Cardiac Resynchronization Therapy (CRT) with MultiPoint Pacing (MPP)*

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 350

Inclusion Criteria

• Meets the current ESC 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 requiring surgical correction
• 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of non-responder patients converted to responders after 6 months<br /><br>of MPP feature turned ON compared to baseline, as measured by Left<br /><br>Ventricular End Systolic Volume (LVESV) reduction of at least 15%</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Reduction of LVESV between baseline and 6 month visit<br /><br>• Packer*s Clinical Composite Score evaluation between the baseline and<br /><br>the 12 month visit; and between the 6 month and the 12 month visit<br /><br>• Reverse LV remodelling, measured as changes in LVESV, LVEDD and<br /><br>LVEF<br /><br>• NYHA Class changes<br /><br>• 6 minutes walking test changes<br /><br>• Quality of Life (MLWHF and EQ-5D) changes</p><br>