MultiPoint Pacing™ Post Market Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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MultiPoint Pacing™ Post Market Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: MPP
* Device: BiV/MPP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MPP Programming<br>This post-market study was designed to characterize the real-world use of MPP technology in patients indicated for CRT device implant. Therefore in order to adequately characterize MPP, data from subjects with MPP programmed continuously or for at least 3 months prior to the final follow-up are reported as the MPP programming group. | Device: MPP<br>* MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously)<br>Device: BiV/MPP<br>* MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., BiV pacing ON at some point in months 1-9 and MPP ON for months 10-12)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CRT Responders as Measured by the Clinical Composite Score (CCS) | 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. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MultiPoint Pacing, Heart Failure, Cardiac Resynchronization Therapy, SJM Quadripolar Biventricular Pacing