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Safety and Efficacy Study of RENEWAL 4 AVT

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00180336
First received: September 12, 2005
Last updated: June 22, 2007
Last verified: June 2007
History of Changes

September 12, 2005
June 22, 2007
July 2004
Not Provided
  • System Complication-Free Rate at 6 months
  • Effectiveness of LV Only/LV Offset at 6 months
Same as current
Complete list of historical versions of study NCT00180336 on ClinicalTrials.gov Archive Site
  • LVESD at 6 months
  • Six-minute walk at 6 months
  • NYHA at 6 months
  • QOL at 6 months
Same as current
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Safety and Efficacy Study of RENEWAL 4 AVT
CONTAK RENEWAL 4 AVT Field Following

The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.

This is a prospective, two-arm, non-randomized, multi-center European field following, designed to demonstrate the safety and effectiveness of the CONTAK RENEWAL 4 AVT device in humans.
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure
  • Tachycardia
  • Atrial Fibrillation
  • Atrial Flutter
  • Ventricular Fibrillation
Device: CRT-D
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
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Inclusion Criteria:

  • Indications for the device
  • Availability for follow-up at an approved Field Following center, at the protocol defined intervals
  • Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
  • Prescribed to stable optimal pharmacologic therapy for HF
  • Age 18 or above, or of legal age to give informed consent specific to national law
  • 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:

  • Right bundle branch block morphology
  • Life expectancy of less than six months due to other medical conditions
  • Expectation of a heart transplant during the period of the study
  • Patients with or who are likely to receive a mechanical tricuspid valve during the course of the study
  • Have a preexisting unipolar pacemaker that will not be explanted/abandoned
  • 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 dexamethasone acetate
  • Enrolled in any other study, including drug investigation
  • Women that are pregnant or planning to become pregnant
  • 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 >= 48 hours in duration and was not anticoagulated for at an adequate therapeutic level (INR >= 2.0) for the 4 weeks prior to enrollment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00180336
Clinicals0004
Not Provided
Not Provided
Boston Scientific Corporation
Not Provided
Principal Investigator: Johannes Sperzel, MD Kerckhoff Klinik Bad Nauheim (Germany)
Boston Scientific Corporation
June 2007

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