The Effect of an Azygos Vein Coil on Defibrillation Threshold

NCT00798174 | Completed Results

• 1 other identifier: 08-0045
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

DFT; Congestive Heart failure (CHF); ICD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Device: Standard configuration vs. azygos coil

Interventions

Standard configuration vs. azygos coil DEVICE

Addition of an azygos vein defibrillation coil instead of a standard SVC coil.

Also known as: Medtronic 6937A Lead

Standard configuration vs. azygos coil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Any contraindication to ICD or the inability to place an azygos vein coil.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Medtronic: collaborator

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• 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.

  PMID: 18950297 BACKGROUND

• 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.

  PMID: 15250862 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Timothy W. Smith
• Organization: Washington University in St. Louis

tsmith@wustl.edu

314-286-1501

Study Officials

• Timothy W. Smith, DPhil, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group undergoing crossover in therapy (defibrillation testing with two different device configurations).

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 26, 2008
• Study Start: December 15, 2008
• Primary Completion: November 18, 2009
• Study Completion: November 18, 2009
• Last Updated: September 28, 2018
• Results First Posted: September 28, 2018

Record last verified: 2018-08

Locations

US (1)