- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00798174
The Effect of an Azygos Vein Coil on Defibrillation Threshold
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard configuration vs. azygos coil
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 |
Addition of an azygos vein defibrillation coil instead of a standard SVC coil.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in the DFT With an Azygos Vein Coil Versus the Standard SVC Coil.
Time Frame: 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. |
During the course of the implant procedure and testing
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Timothy W. Smith, DPhil, MD, Washington University School of Medicine
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-0045
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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