Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
73 participants
INTERVENTIONAL
2003-11-30
2008-02-29
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CONTAK RENEWAL 3 AVT
CONTAK RENEWAL 3 AVT
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Locations
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Multiple locations in the US
Saint Paul, Minnesota, United States
Countries
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References
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Saxon LA, Greenfield RA, Crandall BG, Nydegger CC, Orlov M, VAN Genderen R. Results of the multicenter RENEWAL 3 AVT clinical study of cardiac resynchronization defibrillator therapy in patients with paroxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 2006 May;17(5):520-5. doi: 10.1111/j.1540-8167.2006.00440.x.
Other Identifiers
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Clinicals0008
Identifier Type: -
Identifier Source: org_study_id