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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
5,850
All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").
Percentage of Non-responder Patients Who Converted to Responders
The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the 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%.
Time frame: Non-responder to responder conversion rate between randomization at 6 months and 12 months
Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase
Reduction of LVESV between baseline and 6 Months visit
Time frame: Baseline vs 6 Months
Clinical Composite Score Evaluation
Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below, * Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation * Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation * Unchanged: the patient was neither improved nor worsened
Time frame: Baseline vs 12 Months
Reverse Left Ventricular (LV) Remodeling
Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months
Time frame: Baseline vs 12 Months
NYHA Class Changes
Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.
Time frame: Baseline vs 12 Months
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Heart Center Research, LLC.
Huntsville, Alabama, United States
Cardiovascular Associates of Mesa
Mesa, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Comprehensive Cardiovascular
Bakersfield, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
Scripps Health
La Jolla, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Cardiac Rhythm Specialists, Inc.
Reseda, California, United States
San Diego Cardiac Center
San Diego, California, United States
Colorado Heart & Vascular, P.C.
Lakewood, Colorado, United States
...and 196 more locations
6MWT Changes
Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU
Time frame: Baseline vs 12 Months
Patient's QoL Score Changes (MLWHF)
Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life).
Time frame: Baseline vs 12 Months