CONTAK RENEWAL 3 AVT

Boston Scientific

Status and phase

Completed

Phase 3

Conditions

Atrial Fibrillation

Heart Failure

Treatments

Device: CONTAK RENEWAL 3 AVT

Study type

Interventional

Funder types

Industry

Identifiers

NCT00158977

Clinicals0008

Details and patient eligibility

About

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

Full 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

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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