Health Condition 1: null- Heart Failure Health Condition 2: I501- Left ventricular failure, unspecified
Conditions
Interventions
Intervention1: MPP Feature ON: The patients will have Multi Point Pacing (MPP) feature turned ON in place of standard Cardiac Resynchronization therapy at 6 months post-implant (only for patients iden
Sponsors
St Jude Medical India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Eligible patients will meet ALL the following: • 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: Patients will be excluded if they meet ANY of the following 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 • Currently participating in any other clinical investigation
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%Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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) changesTimepoint: 12 Months;Reduction of LVESV between baseline and 6 month visitTimepoint: 6 Months | — |
Countries
Australia, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, India, Italy, Poland, Portugal, Saudi Arabia, Switzerland, United Kingdom
Contacts
Public ContactSumit Anand
St. Jude Medical India Pvt. Ltd
Outcome results
None listed