Surgical Planning for Reconstruction of Complex Heart Defects

NCT00972608 | Completed

• 1 other identifier: IRB00014388
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to utilize cardiac imaging data acquired as part of the standard of care for these patients, such as MRI, 3D echo, and CT, and existing 3D reconstruction protocols to assess the feasibility of using surgical planning in the treatment of patients with complex cardiac defects. The specific aims of the project are as follows:

1. 1.Develop a protocol to reconstruct heart models from patient imaging data and perform "virtual" surgery on reconstructed 3D anatomy using appropriate, pre-existing patient datasets.
2. 2.Use the developed protocol to prospectively plan and evaluate the possible surgical options for new patients.
3. 3.Validate that the optimal virtual anatomy agrees with what was surgically implemented using post-operative patient scans, when available.

Conditions

Double Outlet Right Ventricle

Keywords

congenital heart disease; surgical planning

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Interventions

Anatomic Reconstruction and Surgical Planning OTHER

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 Criteria

• Age: Up to 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• any pre- or post-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

You may not qualify if:

• upon review by engineers at Georgia Tech, the image quality of the acquired scans is deemed insufficient to reconstruct an accurate 3D model

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Georgia Institute of Technology

Atlanta, Georgia, 30332, United States

Location

MeSH Terms

Conditions

Double Outlet Right Ventricle; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Septal Defects, Ventricular; Heart Septal Defects; Cardiovascular Abnormalities; Cardiovascular Diseases; Transposition of Great Vessels; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kirk Kanter, MD

  Emory University/Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

• Tim Slesnick, MD

  Children's Healthcare of Atlanta

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 7, 2009
• Study Start: August 1, 2009
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

US (2)