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St Paul, Minnesota 55112


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

Study summary:

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


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



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Location Contact:

St Paul, Minnesota 55112
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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