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Sponsors and Collaborators: |
Washington University School of Medicine Medtronic |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00798174 |
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 |
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Heart Failure |
Device: Azygos vein coil |
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 |
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 |
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Standard: No Intervention
The DFT with the standard SVC coil.
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Azygos coil: Experimental
DFT with the azygos vein coil in place.
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Device: Azygos vein coil
Addition of an azygos vein defibrillation coil instead of a standard SVC coil.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Timothy W. Smith, DPhil, MD | Washington University School of Medicine |
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 |
DFT CHF ICD |
Heart Failure Heart Diseases |
Cardiovascular Diseases |