Attain Stability™ Quad Clinical Study

The Attain Stability Quad Clinical Study is a prospective, non-randomized, multi-site,
global, investigational Device Exemption (IDE), interventional clinical study. The purpose of
this clinical study is to evaluate the safety and efficacy of the Attain Stability™ Quad MRI
SureScan LV Lead (Model 4798). This will be assessed through a primary safety and primary
efficacy endpoints.

All subjects included in the study will be implanted with a Medtronic market released de novo
CRT-P or CRT-D device, compatible market released Medtronic RA and Medtronic RV leads and an
Attain Stability Quad MRI SureScan LV Lead (Model 4798).

Up to 471 subjects will be enrolled into the study and up to 471 Attain Stability Quad MRI
SureScan LV Lead (Model 4798) implanted, to ensure a minimum effective sample size of 400
Model 4798 leads implanted with 6 months post implant follow up visits (assuming 15%
attrition) at up to 56 sites worldwide.

Inclusion Criteria:

- Patient meets CRT implant criteria as determined by local regulatory and/or hospital
policy (i.e. US subjects should meet CRT device indications per the HRS/ACC/AHA
guidelines)

- Patient (or legally authorized representative) has signed and dated the study-specific
Informed Consent Form

- Patient is 18 years of age or older, or is of legal age to give informed consent per
local and national law

- Patient is expected to remain available for follow-up visits

Exclusion Criteria:

- Patient has had a previous unsuccessful LV lead implant attempt

- Patient has a previous CRT system or LV lead implanted (for example, transvenous or
epicardial)

- Patient is currently implanted with a recalled (i.e. market-withdrawn, recalled or
safety alert) RA and/or RV lead

- Patient has known coronary venous vasculature that is inadequate for lead placement

- Patient has unstable angina pectoris or has had an acute myocardial infarction (MI)
within the past 30 days

- Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal
coronary angioplasty (PTCA) within the past 90 days

- Patient has contraindications for standard transvenous cardiac pacing (e.g.,
mechanical right heart valve)

- Patient has had a heart transplant (patients waiting for heart transplants are allowed
in the study)

- Patient has known renal insufficiency that would prevent them from receiving an
occlusive venogram during the implant procedure

- Patient is contraindicated for <1mg dexamethasone acetate

- Patient is enrolled in any concurrent drug and/or device study that may confound the
results of this study

- Patient has a terminal illness and is not expected to survive more than six months

- Patient meets exclusion criteria required by local law (e.g. age, pregnancy, breast
feeding, etc.)

- Patient is unable to tolerate an urgent thoracotomy