Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead

Study Overview
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Brief Summary
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This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population. The study will be conducted at a maximum of 20 investigational centers located in the United States and a total of 68 patients will be enrolled.

Detailed Description
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The investigational left heart lead, QuickFlex Model 1258T, will be implanted with a legally marketed St. Jude Medical cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) device. Patients will be followed at Pre-Discharge, 1-Month, 3-Month,and then every 6 months until the end of the study.

Official Title
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QuickFlex Micro Model 1258T Left Heart Pacing Lead

Conditions
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Heart Failure

Intervention / Treatment
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* Device: QuickFlex Micro Model 1258T Left Heart Lead


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Approved indication for CRT-D system Exclusion Criteria: Previous cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment Previous left ventricular (LV) lead implant Have had a heart attack,unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (PTCA),coronary artery bypass grafting (CABG), Stent) within 40 days prior to enrollment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QuickFlex micro 1258T left heart lead<br> | Device: QuickFlex Micro Model 1258T Left Heart Lead<br>* Implantation of QuickFlex Micro 1258T left heart lead in combination with a CRT-D system.<br>* Other names: Model 1258T left heart pacing lead;|

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 | A Kaplan-Meier survival analysis was carried out for left ventricular lead related complications through 3 months. Percentage of patients who remained free from complications at 3 months was reported. | 3 months | 
| Percentage of Successful Left Ventricular Lead Implants | Left ventricular lead implant success rate was calculated as the total number of patients who had a successful implant of the left ventricular QuickFlex Micro Model 1258T lead divided by the total number of patients who had an attempted implant. A successful implant was defined as the placement of the left ventricular lead in the coronary sinus for the purposes of pacing of the left ventricle with connection to the pulse generator. | 3 months | 
| Left Ventricular Bipolar Pacing Capture Threshold (Volts) | The mean left ventricular capture threshold (amount of energy needed to pace the heart) is reported. An overall mean capture threshold of < 3 volts is required to meet this endpoint. | 3 months | 

 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, ICD