NCT00158977CompletedPhase 3
CONTAK RENEWAL 3 AVT Study
Boston Scientific Corporation2 sites in 1 country73 target enrollmentStarted: November 1, 2003Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 73
- Locations
- 2
- Primary Endpoint
- Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months
Study Overview
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 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months
Time Frame: 3 months
Effectiveness Endpoint: To demonstrate the effective termination of induced episodes of atrial fibrillation by cardioversion
Time Frame: 3 months
Effectiveness Endpoint: To correctly detect and classify atrial arrhythmias (AF and/or SVT) from all other rhythms
Time Frame: 3 months
Secondary Outcomes
- Safety Endpoint: Ventricular Fibrillation (VF) Detection Time(3 months)
- Safety Endpoint: Percent BiV Pacing(3 months)
- Safety Endpoint: EASYTRAK 2 Lead Complication-Free Rate(3 months)
- Safety Endpoint: Rate of Inappropriate Response to BiV Trigger Feature(3 months)
Investigators
Study Sites (2)
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