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CONTAK RENEWAL 3 AVT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00158977
First received: September 8, 2005
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Heart Failure
Atrial Fibrillation
 Device: CONTAK RENEWAL 3 AVT
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CONTAK RENEWAL 3 AVT Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Safety Endpoint: To show that the RENEWAL 3 AVT system functions safely at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Effectiveness Endpoint: To demonstrate the effective termination of induced episodes of atrial fibrillation by cardioversion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Effectiveness Endpoint: To correctly detect and classify atrial arrhythmias (AF and/or SVT) from all other rhythms [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety Endpoint: Ventricular Fibrillation (VF) Detection Time [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Safety Endpoint: Percent BiV Pacing [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Safety Endpoint: EASYTRAK 2 Lead Complication-Free Rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Safety Endpoint: Rate of Inappropriate Response to BiV Trigger Feature [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 73
Study Start Date: November 2003
Study Completion Date: February 2008
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CONTAK RENEWAL 3 AVT
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158977

Locations
United States, Minnesota
Multiple locations in the US
St Paul, Minnesota, United States, 55112
Sponsors and Collaborators
Boston Scientific Corporation
  More Information

Publications:

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00158977     History of Changes
Other Study ID Numbers: Clinicals0008
Study First Received: September 8, 2005
Last Updated: September 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
heart failure
atrial fibrillation
cardiac resynchronization therapy defibrillator

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013