CONTAK RENEWAL 3 AVT

CONTAK RENEWAL 3 AVT Study

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Atrial Fibrillation
• Intervention / Treatment: Device: CONTAK RENEWAL 3 AVT

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • St Paul, Minnesota, United States, 55112
      • Multiple Locations in the US

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 8, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): September 29, 2011
• Last Update Submitted That Met QC Criteria: September 28, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: atrial fibrillation; heart failure; cardiac resynchronization therapy defibrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: Clinicals0008