Quadripolar Pacing Post Approval Study

Study Overview
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Brief Summary
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The purpose of this post-approval study is to evaluate the acute and chronic performance of a Quadripolar CRT-D device system in a patient population indicated for cardiac resynchronization therapy (CRT).

Detailed Description
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Quad PAS is a multi-center, post-approval study. Patients who meet inclusion/exclusion criteria will have an attempted implant of a Quadripolar CRT-D device system (device and left ventricular (LV) lead). Patients who have an unsuccessful implant will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician chooses to do so. Patients enrolled in the study will be followed at 6 months, and every 6 months thereafter, for 60 months of follow up (5 years). After patients complete 60 months of follow-up, their participation in the study will be terminated.

Official Title
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Quadripolar Pacing Post Approval Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: CRT-D System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Approved indication per current American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system for treatment of heart failure or life threatening ventricular tachyarrhythmia(s). Participated in the Promote® Q CRT-D and Quartet™ Left Ventricular Heart Lead Study (Investigational Device Exemption (IDE) study), or are receiving a new Quadripolar CRT-D device system implant or are undergoing an upgrade from an existing implantable cardioverter-defibrillator or pacemaker implant with no prior LV lead placement. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations Exclusion Criteria: Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate Have a life expectancy of less than 5 years due to any condition Be 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRT-D System<br>St. Jude Medical (SJM) Promote® Q/Promote® Quadra/Unify Quadra™ CRT-D system. | Device: CRT-D System<br>* Implantation of a CRT-D System<br>* Other names: CRT-D and LV pacing lead;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication free survival rate related to the CRT-D system | Complication free survival rate through 5 years for complications related to the CRT-D system | 5 years | 
| Complication free survival rate related to the LV lead | Complication free survival rate at 5 years for complications related to the LV lead | 5 years | 
| Mean programmed LV lead pacing capture threshold | Mean programmed LV lead pacing capture threshold at 5 years | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left heart pacing lead, Cardiac resynchronization therapy (CRT), Heart Failure, Quadripolar pacing