Ignite Creation Date:
2024-05-05 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00798174
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2008-11-24
Brief Title:
The Effect of an Azygos Vein Coil on Defibrillation Threshold
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
The Effect of an Azygos Vein Coil on Defibrillation Threshold
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 average reduction in the DFT if any that results from the addition of the azygos lead
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 ventricular fibrillation 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 20 Joule J 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None