Baylor Scott & White All Saints Medical Center – Fort Worth is currently enrolling patients for a study designed 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.
The prospective, randomized, multi-center trial will collect data 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 left ventricle end-systolic volume (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.
Enrollment estimates are expected to be approximately 6,800 participants. Primary and second outcomes measures for the trial include:
Primary:
- CRT Response after six months of MPP
Secondary:
- Reduction of LVESV in the acute phase of baseline to six month visit
- Packer’s Clinical Composite Score evaluation between baseline and 12 months; six and 12 months
- Evaluation of reverse LV remodeling, measured as changed in echo values LVESV, LVEDD and LVEF
Eligibility criteria are included below. For a complete list of eligibility criteria and outcomes measures, visit: ClinicalTrials.gov. (Study NCT#: NCT02006069).
Inclusion Criteria:
- Signed informed consent
- Meets the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs)
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