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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014