18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Difference in the DFT With an Azygos Vein Coil Versus the Standard SVC Coil.Primary· During the course of the implant procedure and testing
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.
DFT wtih Azygos coil
Group
Value
95% CI
Standard Configuration vs. Azygos Coil
10.4
± 7.7
DFT with Standard Configuration
Group
Value
95% CI
Standard Configuration vs. Azygos Coil
12.2
± 8.61
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 hours.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Standard Configuration vs. Azygos Coil Configuation
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 28 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00798174.