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Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique

Sponsor
Emory University (Other)
Overall Status
Terminated
CT.gov ID
NCT00384163
Collaborator
(none)
50
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Pulmonary valve replacement in the adult population is an uncommon operation. The majority of native valve pathology in adults involves the mitral, aortic, and occasionally tricuspid valves. On the other hand, right ventricular outflow tract and pulmonary valve disease is quite common in children, especially with tetralogy of fallot, truncus arteriosus, pulmonary atresia/ventricular septal defect, and double outlet right ventricle. Unfortunately, right ventricular pathology often develops in adulthood as a result of pulmonary insufficiency or pulmonary stenosis created by previous childhood operations. Without the valve size constraints present at prior operations, these patients can be well-served by the placement of adult-sized bioprosthetic valves. There are limited descriptions in the adult cardiac literature of the actual technique of pulmonary valve replacement. We present our current technique and the pitfalls encountered when performing pulmonary valve replacement in adults.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This will be primarily a technique paper. The only clinical data points I am interested in are the presence of pulmonary stenosis, pulmonary insufficiency or perivalvular leak on the initial post-operative echocardiogram. I estimate reviewing 50 patients' charts dated March 22.2003 through and including March 22.2006 at Emory Hospital .

    Primary Aim: Present an effective technique for pulmonary valve replacement

    Secondary Aim: Present our excellent technical results of PVR in our adult congenital patients

    Study Design

    Study Type:
    Observational
    Time Perspective:
    Retrospective
    Official Title:
    Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique
    Study Start Date :
    Aug 1, 2007
    Actual Primary Completion Date :
    Aug 1, 2007
    Actual Study Completion Date :
    Aug 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Adults undergoing pulmonary valve replacement

      • at Emory Hospital

      • between 3.22.03 amd 3.22.06

      Exclusion Criteria:
      • those charts that do not fall under inclusion criteria

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Emory University Atlanta Georgia United States 30306

      Sponsors and Collaborators

      • Emory University

      Investigators

      • Principal Investigator: Brian E Kogon, MD, Emory University SOM

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Brian Kogon, Associate Professor of Surgery, Emory University
      ClinicalTrials.gov Identifier:
      NCT00384163
      Other Study ID Numbers:
      • 0453-2006
      First Posted:
      Oct 5, 2006
      Last Update Posted:
      Nov 26, 2013
      Last Verified:
      Nov 1, 2013
      Keywords provided by Brian Kogon, Associate Professor of Surgery, Emory University
      cardiac
      adult
      PVR

      Study Results

      No Results Posted as of Nov 26, 2013