contak renewal 3 avt

Conditions: Heart Failure; Atrial Fibrillation

Summary: the renewal 3 avt device is designed to treat patients suffering from hf, with a history of or at risk of developing atrial and ventricular arrhythmias

a clinical evaluation to: * confirm that there are no adverse interactions when ventricular tachyarrhythmia (icd), heart failure (hf) and atrial tachyarrhythmia (at) therapies are combined * confirm cardiac resynchronization therapy (crt) and ventricular tachyarrhythmia (icd) therapy is delivered in the presence of atrial therapies * demonstrate the safety and effectiveness of atrial therapies in a heart failure population

Eligibility criteria:
inclusion criteria: patients who meet the following criteria should be given consideration for inclusion in the clinical investigation: * meet all device indications and contraindications * willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol * prescribed to stable optimal pharmacologic therapy for heart failure * creatinine \< 2.5 mg/dl obtained no more than two weeks prior to enrollment * age 18 or above, or of legal age to give informed consent specific to state and national law * geographically stable residents who are available for follow-up * able to provide documented evidence of one or more episodes of af/at within 12 months of implantation note: guidant recommends anticoagulation therapy per physician discretion. 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

Keywords: heart failure atrial fibrillation cardiac resynchronization therapy defibrillator