Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)

Study Overview
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Brief Summary
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Prospective, multi-center, single arm, post approval study to be conducted in the United States.

Detailed Description
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Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used in accordance with its approved labeling.

Official Title
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Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)

Conditions
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Left Ventricular Dysfunction

Intervention / Treatment
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* Device: CRT-D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed. Subjects must meet BSC labeled indication for CRT-D implantation. Subjects must have a functional RA lead and RV lead implanted Subjects who are willing and capable of providing informed consent Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation. Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment Subjects with documented history of permanent AF Subjects with documented permanent complete AV block Subjects who are expected to receive a heart transplant during the 12 months course of the study Subjects with documented life expectancy of less than 12 months Subjects who enrolled in any other concurrent study or registry, with the exception of mandatory national or governmental registry, without prior written approval from BSC

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use. | Device: CRT-D<br>* Left Ventricular MultiSite Pacing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LV MSP Feature Related Complication-Free Rate | Proportion of subjects free from LVMSP feature related complications at 12 months | Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration. | 
| Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months | Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months. | 12 Month Follow Up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacing