N/A
Completed N=32
The Effect of an Azygos Vein Coil on Defibrillation Threshold
Source: ClinicalTrials.gov NCT00798174 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Difference in the DFT With an Azygos Vein Coil Versus the Standard SVC Coil. — 10.4; 12.2 Joules — p=0.103
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in the DFT With an Azygos Vein Coil Versus the Standard SVC Coil. |
10.4; 12.2 | 0.103 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00798174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.