Clinical trial NCT00158977: CONTAK RENEWAL 3 AVT
Official title: CONTAK RENEWAL 3 AVT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Atrial Fibrillation
Keywords: heart failure
atrial fibrillation
cardiac resynchronization therapy defibrillator
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months
timeFrame: 3 months
measure: Effectiveness Endpoint: To demonstrate the effective termination of induced episodes of atrial fibrillation by cardioversion
timeFrame: 3 months
measure: Effectiveness Endpoint: To correctly detect and classify atrial arrhythmias (AF and/or SVT) from all other rhythms
timeFrame: 3 months
Secondary outcomes:
measure: Safety Endpoint: Ventricular Fibrillation (VF) Detection Time
timeFrame: 3 months
measure: Safety Endpoint: Percent BiV Pacing
timeFrame: 3 months
measure: Safety Endpoint: EASYTRAK 2 Lead Complication-Free Rate
timeFrame: 3 months
measure: Safety Endpoint: Rate of Inappropriate Response to BiV Trigger Feature
timeFrame: 3 months
Other outcomes:
Locations:
city: St Paul
country: United States
facility: Multiple locations in the US
state: Minnesota
Study officials:
References:
citation: 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.