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The Effect of an Azygos Vein Coil on Defibrillation Threshold
This study is currently recruiting participants.
Verified by Washington University School of Medicine, November 2008
Sponsors and Collaborators: Washington University School of Medicine
Medtronic
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00798174
  Purpose

When implantable cardiac defibrillators are implanted (ICDs), the defibrillation threshold (DFT), of the amount of energy required to effectively terminate life-threatening arrhythmias is determined. The device is then programmed to discharge a larger amount of energy in order to provide a safety margin. In some patients, the DFT is so high, that an adequate safety margin is not programmable. Placement of a defibrillation lead in the azygos vein has been found to be helpful in these patients. This goal of this trial is to attempt to quantify the reduction in the DFT that results from the


Condition Intervention
Heart Failure
Device: Azygos vein coil

MedlinePlus related topics: Heart Failure
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: The Effect of an Azygos Vein Coil on Defibrillation Threshold

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Difference in the DFT with an azygos vein coil versus the standard SVC coil. [ Time Frame: Depented on recruitment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: November 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard: No Intervention
The DFT with the standard SVC coil.
Azygos coil: Experimental
DFT with the azygos vein coil in place.
Device: Azygos vein coil
Addition of an azygos vein defibrillation coil instead of a standard SVC coil.

Detailed Description:

Patients undergoing placement of an ICD for the primary or secondary prevention of sudden cardiac death will be asked to participate. Patients will undergo implantation of a standard right ventricular ICD lead at the time of ICD implantation. In addition, patient will receive another high voltage ICD lead placed in the azygos vein as has been previously described in the literature (1). After sedating the patient, the DFT will be determined using a binary search algorithm. This consists of testing the device at a given output for the first shock after inducing VF. Should the shock fail, external defibrillation will be attempted, as is the standard method for performing DFT testing. As per the standard method of DFT testing, VF will be induced a second time, with the shock strength dependent on the success of the first shock. If the first shock was unsuccessful, the second will be at a higher output. If the first shock was successful, the second will be at a lower output. A third shock will then be delivered, based on the success or failure of the preceding shock to define the DFT. Of note, as the device can be programmed to give multiple shocks for one episode, VF will not necessarily need to be induced each time. For example, VF could be induced, and the device programmed to give a 20J shock followed by a 23J shock if not successful, thus limiting the number of VF inductions required. DFT testing will be done using both the standard configuration of high voltage leads as well as using the azygos lead. We hypothesize that using the azygos lead will result in a lower DFT.

  Eligibility

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

Inclusion Criteria:

  • Any patient undergoing elective placement of an ICD for the primary or secondary prevention of sudden cardiac death is eligible. Exclusion criteria include any contraindication to endovascular ICD implantation which includes but is not limited to; active infection, occluded venous access, or inability to perform DFT testing secondary to the inability to sedate the patient or hemodynamic compromise.

Exclusion Criteria:

  • Any contraindication to ICD or the inability to place an azygos vein coil.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798174

Contacts
Contact: Matthew P Latacha, MD 314-454-7804 mlatacha@im.wustl.edu
Contact: Timothy W Smith, DPhil, MD (314) 454-7834 tsmith@im.wustl.edu

Locations
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Matthew P. Latacha, MD     314-454-7804     mlatacha@im.wustl.edu    
Principal Investigator: Timothy W. Smith, DPhil, MD            
Sub-Investigator: Jonas A Cooper, MD            
Sub-Investigator: Matthew P Latacha, MD            
Sponsors and Collaborators
Washington University School of Medicine
Medtronic
Investigators
Principal Investigator: Timothy W. Smith, DPhil, MD Washington University School of Medicine
  More Information

Publications:
Responsible Party: Washinton Unviersity School of Medicine ( Timothy Wm. Smith, D.Phil.,M.D. )
Study ID Numbers: 08-0045
Study First Received: November 24, 2008
Last Updated: November 24, 2008
ClinicalTrials.gov Identifier: NCT00798174  
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
DFT
CHF
ICD

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009