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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard configuration vs. azygos coil | Experimental | The DFT with the standard Superior Vena Cava (SVC) coil vs. DFT with the azygos coil. In this crossover study, each patient serves and own control, with defibrillation testing performed with and with the azygos coil |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard configuration vs. azygos coil | Device | Addition of an azygos vein defibrillation coil instead of a standard SVC coil. |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in the DFT With an Azygos Vein Coil Versus the Standard SVC Coil. | Defibrillation threshold will be estimated by repeat defibrillation testing using an azygos coil and using an SVC coil (and compared). The outcome measure quoted below is the mean DFT using the azygos coil vs. the mean DFT using the standard configuration. | During the course of the implant procedure and testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy W. Smith, DPhil, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18950297 | Background | Cooper JA, Latacha MP, Soto GE, Garmany RG, Gleva MJ, Chen J, Faddis MN, Smith TW. The azygos defibrillator lead for elevated defibrillation thresholds: implant technique, lead stability, and patient series. Pacing Clin Electrophysiol. 2008 Nov;31(11):1405-10. doi: 10.1111/j.1540-8159.2008.01203.x. | |
| 15250862 | Background |
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Patients undergoing Implantable Cardioverter-Defibrillator (ICD) implantation in the electrophysiology laboratory were recruited. Both outpatients (recruited from the electrophysiology clinic) and inpatients (recruited from Barnes-Jewish Hospital) were included.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Configuration First |
(Azygos vein coil: Addition of an azygos vein defibrillation coil in place of a standard superior vena cava (SVC) coil.) |
| FG001 | Azygos Coil Configuration First |
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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32 patients were enrolled. There was inability to place an and azygos coil in 6. 1 could not be sedated for defibrillation testing. 25 patients were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard SVC Coil vs. Azygos Coil | The DFT with the standard SVC coil vs. DFT with the azygos vein coil in place. Azygos vein coil: Addition of an azygos vein defibrillation coil instead of a standard SVC coil. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in the DFT With an Azygos Vein Coil Versus the Standard SVC Coil. | Defibrillation threshold will be estimated by repeat defibrillation testing using an azygos coil and using an SVC coil (and compared). The outcome measure quoted below is the mean DFT using the azygos coil vs. the mean DFT using the standard configuration. | All enrolled patient who were able to undergo azygos coil implant and defibrillation testing. | Posted | Mean | Standard Deviation | Joules | During the course of the implant procedure and testing |
|
24 hours
Definitions are as the clinicaltrials.gov definitions.
Patients were follow for clinically for 24 hours after their implant and defibrillation testing procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Configuration vs. Azygos Coil Configuation | The DFT with the standard SVC coil vs. DFT with the azygos vein coil in place. Since all subjects underwent attempted azygos vein implantation, the implantation procedure was the same for the arm in which the standard configuration was tested first and the arm in which the azygos configuration was tested. first. Therefore, the two arms (Standard configuration tested first and Azygos configuration tested first) were combined for the purpose of adverse events. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of intergrity of Lead introducer | Blood and lymphatic system disorders | Non-systematic Assessment | In one patient with very constricted vascular access, the introducer sheath for azygos vein lead became torn. Small fragments remained embedded in the soft tissue near the access site. No sequelae and no prolongation of hospitalization. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Timothy W. Smith | Washington University in St. Louis | 314-286-1501 | tsmith@wustl.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Single group undergoing crossover in therapy (defibrillation testing with two different device configurations).
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| Cesario D, Bhargava M, Valderrabano M, Fonarow GC, Wilkoff B, Shivkumar K. Azygos vein lead implantation: a novel adjunctive technique for implantable cardioverter defibrillator placement. J Cardiovasc Electrophysiol. 2004 Jul;15(7):780-3. doi: 10.1046/j.1540-8167.2004.03649.x. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
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