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CONTAK RENEWAL 3 AVT

Primary Purpose

Heart Failure, Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CONTAK RENEWAL 3 AVT
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, atrial fibrillation, cardiac resynchronization therapy defibrillator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 Note: Women of childbearing potential must have a negative pregnancy test within 7 days of enrollment

Sites / Locations

  • Multiple locations in the US

Outcomes

Primary Outcome Measures

Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months
Effectiveness Endpoint: To demonstrate the effective termination of induced episodes of atrial fibrillation by cardioversion
Effectiveness Endpoint: To correctly detect and classify atrial arrhythmias (AF and/or SVT) from all other rhythms

Secondary Outcome Measures

Safety Endpoint: Ventricular Fibrillation (VF) Detection Time
Safety Endpoint: Percent BiV Pacing
Safety Endpoint: EASYTRAK 2 Lead Complication-Free Rate
Safety Endpoint: Rate of Inappropriate Response to BiV Trigger Feature

Full Information

First Posted
September 8, 2005
Last Updated
September 28, 2011
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00158977
Brief Title
CONTAK RENEWAL 3 AVT
Official Title
CONTAK RENEWAL 3 AVT Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Atrial Fibrillation
Keywords
heart failure, atrial fibrillation, cardiac resynchronization therapy defibrillator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CONTAK RENEWAL 3 AVT
Intervention Description
CONTAK RENEWAL 3 AVT
Primary Outcome Measure Information:
Title
Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months
Time Frame
3 months
Title
Effectiveness Endpoint: To demonstrate the effective termination of induced episodes of atrial fibrillation by cardioversion
Time Frame
3 months
Title
Effectiveness Endpoint: To correctly detect and classify atrial arrhythmias (AF and/or SVT) from all other rhythms
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Safety Endpoint: Ventricular Fibrillation (VF) Detection Time
Time Frame
3 months
Title
Safety Endpoint: Percent BiV Pacing
Time Frame
3 months
Title
Safety Endpoint: EASYTRAK 2 Lead Complication-Free Rate
Time Frame
3 months
Title
Safety Endpoint: Rate of Inappropriate Response to BiV Trigger Feature
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Multiple locations in the US
City
St Paul
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16684026
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.
Results Reference
result

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CONTAK RENEWAL 3 AVT

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