Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study

Study Overview
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Brief Summary
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The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.

Official Title
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Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s) Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement. Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations Exclusion Criteria: Have had a recent CVA or TIA within three months of enrollment Have a contraindication for an emergency thoracotomy Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months Have undergone a cardiac transplantation within 40 days of enrollment Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment 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 6 months due to any condition Are less than 18 years of age Are unable to comply with the follow up schedule

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRT-D and LV lead<br> | Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)<br>* Promote Q CRT-D and Quartet LV lead<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Left Ventricular Lead-Related Complications Through 3 Months | The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months. | 3 months | 
| Freedom From System-related Complications Through 3 Months | The co-primary safety endpoint for this study is freedom from system-related complications through 3 months. | 3 Months | 
| The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months. | The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil). | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRT, Heart Failure, LV Leads