MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)
MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)
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.
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.
Inclusion 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
Atrial Fibrillation:
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
Taipei City, Taipei 10002, Taiwan