MultiPoint Pacing™ Post Market Study

Completed

Brief Summary: This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT implantation.

Detailed Description: Any patient who received a market approved SJM Quadra Allure MP, Quadra Assura MP, or newer SJM CRT MP device is eligible for enrollment in the study. MultiPoint Pacing (MPP) programming guidance will be specified in the protocol. Patients will be followed for 12 months after implant. Data will be collected at Baseline (within 30 days prior to implant), Post-Implant (within 30 days following successful CRT device implant), 3, 6, 12 months and during any unscheduled follow-up visit.

Recruitment & Eligibility

Inclusion Criteria

Are scheduled to receive a new CRT implant or an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant (SJM CRT MP device and SJM Quadripolar Lead) with no prior left ventricular lead placement
Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria

Are expected to receive a heart transplant during the duration of the study
Have an epicardial ventricular lead system (Active or Inactive)
Are less than 18 years of age
Are currently participating in a clinical investigation including an active treatment arm and belong to the active arm
Are not expected to complete the study follow-up schedule or duration due to any health condition other than heart failure, such as malignancy, indication for heart transplant or hospice care

Primary Outcome Measures

Name	Time	Method
Number of CRT Responders as Measured by the Clinical Composite Score (CCS)	One year	The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly better", "moderately better, "markedly better". CCS components were used to classify or score subjects as "IMPROVED" (at least one-class improvement in NYHA Class or improvement by PGA "moderately" or "markedly" better AND no HF events AND no cardiovascular death), or "WORSENED" (worsening in NYHA Class OR worsening by PGA "moderately" or "markedly" worse OR presence of HF events OR Cardiovascular death, or "UNCHANGED" (neither "improved" or "worsened"). Note CCS is not a numeric score. A responder is defined as improved or unchanged from baseline and non-responder is defined as worsened from baseline.

Secondary Outcome Measures

Name	Time	Method

Locations (128): University Hospital - Univ. of Alabama at Birmingham (UAB)
🇺🇸
Birmingham, Alabama, United States
Heart Center Research, LLC.
🇺🇸
Huntsville, Alabama, United States
Integrated Medical Services
🇺🇸
Avondale, Arizona, United States
Cardiovascular Consultants Ltd
🇺🇸
Glendale, Arizona, United States
Arizona Arrhythmia Research Center
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Phoenix, Arizona, United States
Phoenix Cardiovascular Research Group
🇺🇸
Phoenix, Arizona, United States
John C. Lincoln North Mountain Hospital
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Phoenix, Arizona, United States
Arizona Arrhythmia Consultants
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Scottsdale, Arizona, United States
Comprehensive Cardiovascular Specialists
🇺🇸
Alhambra, California, United States
USC University Hospital
🇺🇸
Los Angeles, California, United States
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University Hospital - Univ. of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States