Cardiac dyssynchrony Heart Failure
Conditions
Interventions
All patients will get an CRT-D device implanted, after 6 months only the
non-responders are randomized in Multipoint Pacing (MPP) or no MPP.
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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% | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of LVESV between baseline and 6 month visit • Packer*s Clinical Composite Score evaluation between the baseline and the 12 month visit; and between the 6 month and the 12 month visit • Reverse LV remodelling, measured as changes in LVESV, LVEDD and LVEF • NYHA Class changes • 6 minutes walking test changes • Quality of Life (MLWHF and EQ-5D) changes | — |
Countries
Netherlands
Outcome results
None listed