Atrial Fibrillation, Heart Failure
Conditions
Keywords
heart failure, atrial fibrillation, cardiac resynchronization therapy defibrillator
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
Interventions
DEVICECONTAK RENEWAL 3 AVT
CONTAK RENEWAL 3 AVT
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months | 3 months |
| Effectiveness Endpoint: To demonstrate the effective termination of induced episodes of atrial fibrillation by cardioversion | 3 months |
| Effectiveness Endpoint: To correctly detect and classify atrial arrhythmias (AF and/or SVT) from all other rhythms | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoint: EASYTRAK 2 Lead Complication-Free Rate | 3 months |
| Safety Endpoint: Percent BiV Pacing | 3 months |
| Safety Endpoint: Rate of Inappropriate Response to BiV Trigger Feature | 3 months |
| Safety Endpoint: Ventricular Fibrillation (VF) Detection Time | 3 months |
Countries
United States
Outcome results
None listed