Status:
COMPLETED
CONTAK RENEWAL 3 AVT
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00158977
Start Date
November 1 2003
End Date
February 1 2008
Last Update
September 29 2011
Active Locations (1)
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1
Multiple locations in the US
Saint Paul, Minnesota, United States, 55112