Safety and Efficacy Study of RENEWAL 4 AVT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00180336
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 25, 2007
Information provided by:
Boston Scientific Corporation

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

Condition or disease Intervention/treatment Phase
Heart Failure Tachycardia Atrial Fibrillation Atrial Flutter Ventricular Fibrillation Device: CRT-D Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CONTAK RENEWAL 4 AVT Field Following
Study Start Date : July 2004

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

Secondary Outcome Measures :
  1. LVESD at 6 months
  2. Six-minute walk at 6 months
  3. NYHA at 6 months
  4. QOL at 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00180336

Kerckhof Klinik
Bad Nauheim, Germany, 61231
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: Johannes Sperzel, MD Kerckhoff Klinik Bad Nauheim (Germany) Identifier: NCT00180336     History of Changes
Other Study ID Numbers: Clinicals0004
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 25, 2007
Last Verified: June 2007

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

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