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Safety and Efficacy Study of RENEWAL 4 AVT
This study has been completed.
Sponsored by: Boston Scientific Corporation
Information provided by: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00180336
  Purpose

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


Condition Intervention Phase
Heart Failure
Tachycardia
Atrial Fibrillation
Atrial Flutter
Ventricular Fibrillation
Device: CRT-D
Phase II
Phase III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
MedlinePlus related topics: Heart Failure
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: CONTAK RENEWAL 4 AVT Field Following

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • System Complication-Free Rate at 6 months
  • Effectiveness of LV Only/LV Offset at 6 months

Secondary Outcome Measures:
  • LVESD at 6 months
  • Six-minute walk at 6 months
  • NYHA at 6 months
  • QOL at 6 months

Estimated Enrollment: 170
Study Start Date: July 2004
Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180336

Locations
Germany
Kerckhof Klinik
Bad Nauheim, Germany, 61231
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Johannes Sperzel, MD Kerckhoff Klinik Bad Nauheim (Germany)
  More Information

Study ID Numbers: Clinicals0004
Study First Received: September 12, 2005
Last Updated: June 22, 2007
ClinicalTrials.gov Identifier: NCT00180336  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Boston Scientific Corporation:
Heart Failure
Tachycardia
Atrial Fibrillation
Atrial Flutter
Ventricular Fibrillation

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Tachycardia
Paroxysmal ventricular fibrillation
Atrial Fibrillation
Atrial Flutter
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009