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

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.

Inclusion Criteria:

1. 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.

2. Is receiving a new market-approved St. Jude Medical quadripolar cardiac
resynchronization therapy system implant with the Quartet 1457Q LV lead.

3. 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.

4. Are 18 years or above, or of legal age to give informed consent specific to state and
national law.

Exclusion Criteria:

1. Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt

2. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate

3. 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.

4. Are pregnant or planning pregnancy in the next 6 months

5. Have a life expectancy of less than 24 months due to any condition