CONTAK RENEWAL 3 AVT

Heart Failure Clinical Trial

Official title:

CONTAK RENEWAL 3 AVT Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158977
• Other study ID #: Clinicals0008
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: September 28, 2011
• Start date: November 2003
• Est. completion date: February 2008

Study information

• Verified date: September 2011
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 2008
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Device:
• CONTAK RENEWAL 3 AVT
CONTAK RENEWAL 3 AVT

Locations

Country	Name	City	State
United States	Multiple locations in the US	St Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Electrophy — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months		3 months	Yes
Primary	Effectiveness Endpoint: To demonstrate the effective termination of induced episodes of atrial fibrillation by cardioversion		3 months	No
Primary	Effectiveness Endpoint: To correctly detect and classify atrial arrhythmias (AF and/or SVT) from all other rhythms		3 months	No
Secondary	Safety Endpoint: Ventricular Fibrillation (VF) Detection Time		3 months	Yes
Secondary	Safety Endpoint: Percent BiV Pacing		3 months	Yes
Secondary	Safety Endpoint: EASYTRAK 2 Lead Complication-Free Rate		3 months	Yes
Secondary	Safety Endpoint: Rate of Inappropriate Response to BiV Trigger Feature		3 months	Yes