The Effect of an Azygos Vein Coil on Defibrillation Threshold

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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The Effect of an Azygos Vein Coil on Defibrillation Threshold

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Standard configuration vs. azygos coil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group undergoing crossover in therapy (defibrillation testing with two different device configurations).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard configuration vs. azygos coil<br>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 | Device: Standard configuration vs. azygos coil<br>* Addition of an azygos vein defibrillation coil instead of a standard SVC coil.<br>* Other names: Medtronic 6937A Lead;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DFT, Congestive Heart failure (CHF), ICD