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Surgical Planning for Reconstruction of Complex Heart Defects

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Kirk R. Kanter, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00972608
First received: September 3, 2009
Last updated: June 1, 2014
Last verified: June 2014
  Purpose

In the United States, approximately 1 in 200 babies are born each year with harmful congenital heart defects (CHD) that require some form of medical management. Often, these defects consist of holes in the septum (the walls between the heart chambers) and/or abnormal development of the heart chambers or major blood vessels. Surgery is the primary treatment course for many of these patients and, through the use of patches and artificial vessels, it is often possible to repair the defects and recreate the normal blood flow path through the heart.

These techniques are not always simple, however, and the surgeon must take great care not to harm the pumping function of the heart. In more complex cases, the surgeon must decide between multiple repair strategies that will have a major effect on the long-term health of the patient. It would be helpful in such cases for the surgeon to be able to assess the repair options prior to the operation using virtual 3-dimensional representations of that patient's anatomy. Having this ability would remove some of the uncertainty from the decision-making process by providing accurate predictions of post-surgical anatomy.

In fact, the technology exists to include such a surgical planning tool into the standard treatment course for these patients. Using 3D anatomical images, acquired from basic techniques such as magnetic resonance (MR), computed tomography (CT), and echocardiography, engineers at Georgia Tech have the ability to build accurate 3D models of patient anatomy, such as the heart. Using these models with a state-of-the-art graphics manipulation tool, surgeons would have the ability to virtually operate on the patient and select the optimal treatment approach, as previously discussed. Similar techniques have already been developed and used to plan surgeries for a limited subset of CHD patients with a single ventricle physiology.

The purpose of this study is to further develop these techniques and apply them to a broader range of CHD patients. To do this, patients undergoing an appropriate surgical repair will be recruited to participate in the study. Images obtained from pre-operative scans will be used to build the anatomical model, which the surgeon will manipulate to test the different available options. By successfully testing and eventually implementing these techniques in the standard of care for CHD patients, the investigators hypothesize that the optimal approach for reconstruction will be implemented more frequently, and thus patient outcomes will improve.


Condition Intervention
Double Outlet Right Ventricle
Other: Anatomic Reconstruction and Surgical Planning

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Surgical Planning for Reconstruction of Complex Heart Defects

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • The ability to accurately (as determined by the participating cardiac surgeons) reconstruct the patient-specific pathology, and realistically (as determined by comparison to post-operative imaging scans) mimic the surgical repairs. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: August 2009
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Anatomic Reconstruction and Surgical Planning
    Standard of care patient-images will be acquired and used to construct a model of the patient anatomy. The model will then be used to simulate surgical options and allow the surgeon to visually evaluate the optimal approach.
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with complex congenital heart defects, such as Double Outlet Right Ventricle, requiring surgical intervention, who are being treated at Children's Healthcare of Atlanta.

Criteria

Inclusion Criteria:

  • any pre-operative patient with a complex heart lesion treated at Children's Healthcare of Atlanta by Dr. Kanter or his team that is appropriate for surgical planning

Exclusion Criteria:

  • upon review by engineers at Georgia Tech, the image quality of the acquired scans is deemed insufficient to reconstruct an accurate 3D model
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972608

Contacts
Contact: Jan Fernandez, BS,RRT,CCRC 404-785-1731 janet.fernandez@choa.org

Locations
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Georgia Institute of Technology Active, not recruiting
Atlanta, Georgia, United States, 30332
Sponsors and Collaborators
Emory University
Investigators
Study Director: William Border, M.B., Ch.B., M.P.H. Children's Healthcare of Atlanta
Principal Investigator: Kirk Kanter, MD Emory University/Children's Healthcare of Atlanta
Study Chair: Tim Slesnick, MD Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Kirk R. Kanter, MD, Professor of Surgery, Emory University
ClinicalTrials.gov Identifier: NCT00972608     History of Changes
Other Study ID Numbers: IRB00014388
Study First Received: September 3, 2009
Last Updated: June 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
congenital heart disease
surgical planning

Additional relevant MeSH terms:
Double Outlet Right Ventricle
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Transposition of Great Vessels

ClinicalTrials.gov processed this record on November 24, 2014