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
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CONTAK RENEWAL 4 AVT Field Following

Resource links provided by NLM:


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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00180336     History of Changes
Other Study ID Numbers: Clinicals0004
Study First Received: September 12, 2005
Last Updated: June 22, 2007
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

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

ClinicalTrials.gov processed this record on October 02, 2014