MultiPoint Pacing IDE Study

Study Overview
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Brief Summary
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This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months. The study will be conducted at a maximum of 50 investigational centers located in the United States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.

Detailed Description
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All subjects will undergo a 2 dimensional Echocardiogram within the 30 days prior to implant, and again at 3, 6 and 9 months post implant. At implant, the final LV pacing configuration is programmed using any one of the 10 available pacing vectors. The paced/sensed atrioventricular (AV) and interventricular (VV) delays may be optimized as per the site's standard of care. Subjects will continue to receive BiV therapy until the 3-month follow-up visit. At the 3-month visit, responder status between Enrollment and 3 months will be assessed using the Clinical Composite Score (CCS). All subjects that are Improved using the definition outlined in the CCS will be grouped together as Responders. All subjects that are Worsened or Unchanged using the definitions outlined in the CCS will be considered as Non-responders. All subjects will undergo acute measurement of cardiac performance (e.g., Echocardiography) at various MPP combinations compared to BiV pacing. Only subjects with equal or better echocardiographic measurements (i.e., EA VTI measurements) with MPP feature on compared to BiV pacing will be randomized in a 1:1 ratio to one of the two arms - BiV arm or MPP arm. At the 9-month visit, responder status will be evaluated once again using the CCS and compared to the status at 3 months.

Official Title
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MultiPoint Pacing IDE Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: MultiPoint Pacing
* Device: Traditional Biventricular Pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets current clinical indication for implantation of a cardiac resynchronization therapy system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s) Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV 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: Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months of enrollment Have an existing Class I recalled lead Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 9 months Have permanent atrial fibrillation (AF) Have undergone a cardiac transplantation within 40 days of enrollment Have had a recent myocardial infarction, unstable angina within 40 days or cardiac revascularization within 3 months of implant. Are currently participating in a clinical investigation that includes an active treatment arm Are pregnant or planning to become pregnant during the duration of the study Have a life expectancy of less than 9 months due to any condition Are less than 18 years of age

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-point pacing arm<br>MultiPoint Pacing | Device: MultiPoint Pacing<br>* Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.<br>|
| Active Comparator: Biventricular arm<br>Traditional Biventricular Pacing | Device: Traditional Biventricular Pacing<br>* Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion | A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint. | Implant to 9 months | 
| Percentage of Non-responders With MPP Compared to Biventricular Pacing | The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient's CCS was classified as worsened, improved or unchanged based on the definitions below: Worsened - patient died due to cardiovascular reasons, experienced a HF event, demonstrated worsening in NYHA class, or had worsening of PGA score compared to the last observation Improved - patient survived without a HF event, and demonstrated either improvement in NYHA class or improvement in PGA score, or both compared to the last observation. Unchanged - patient was neither improved nor worsened For patients who were responders at the 3-month visit, those who were Improved and Unchanged between 3 and 9 months were classified as responders, whereas those who were Worsened were grouped together as non-responders. | 3 months to 9 months |