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

September 8, 2005
September 28, 2011
November 2003
October 2004   (final data collection date for primary outcome measure)
  • 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 ]
  • 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
Complete list of historical versions of study NCT00158977 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
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

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
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure
  • Atrial Fibrillation
Device: CONTAK RENEWAL 3 AVT
CONTAK RENEWAL 3 AVT
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
February 2008
October 2004   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00158977
Clinicals0008
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Not Provided
Boston Scientific Corporation
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP