CONTAK RENEWAL 3 AVT

Exclusion Criteria

• •Patients who will be excluded from the investigation are those who meet any one of the following criteria:
• •Have a preexisting non-Guidant left ventricular lead
• •Have a preexisting unipolar pacemaker that will not be explanted/abandoned
• •Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
• •Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment
• •Have a known hypersensitivity to a 0.7 mg dose of dexamethasone acetate
• •Have surgically uncorrected primary valvular heart disease
• •Currently requiring hemo-dialysis
• •Have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
• •Have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
• •Have a mechanical tricuspid heart valve
• •Enrolled in any concurrent study, without Guidant written approval, that may confound the results of this study
• •A Cerebral Vascular Event/ Transient Ischemic Attack within 12 months of implantation
• •During the four weeks prior to implantation, a patient experiences an episode of AF ³ 48 hours in duration and was not anticoagulated at an adequate therapeutic level for the 4 weeks prior to enrollment with an INR = 2.0-3.0 at enrollment
• •Women who are pregnant or plan to become pregnant
• •Note: Women of childbearing potential must have a negative pregnancy test within 7 days of enrollment