Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study

Study Overview
=================
Brief Summary
-----------------
The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.

Detailed Description
-----------------
This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead. A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide. All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed.

Official Title
-----------------
A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Quartet 1457Q LV Lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets current St. Jude Medical clinical indication for implantation of a cardiac resynchronization therapy system:  to provide a reduction of the symptoms of moderate to severe heart failure (New York Heart Association Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, OR  to maintain synchrony of the left and right ventricles in patients who have undergone an Atrio Ventricular nodal ablation for chronic (permanent) atrial fibrillation and have New York Heart Association Functional Class II or III heart failure. Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead. Have the 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. Are 18 years or above, or of legal age to give informed consent specific to state and national law. Exclusion Criteria: Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate Patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in other studies may be allowed if pre-approval is granted from the study manager. Are pregnant or planning pregnancy in the next 6 months Have a life expectancy of less than 24 months due to any condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Subjects implanted with the Quartet 1457Q LV lead | Device: Quartet 1457Q LV Lead<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Free From LV Lead-related Complications Through 3 Months | A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead. A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect. | 3 months |