Double Outlet Right VentricleNCT00972608
Surgical Planning for Reconstruction of Complex Heart Defects
An observational study of Double Outlet Right Ventricle, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Double Outlet Right Ventricle
- What is being tested?
- Anatomic Reconstruction and Surgical Planning
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to 9 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- upon review by engineers at Georgia Tech, the image quality of the acquired scans is deemed insufficient to reconstruct an accurate 3D model
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Georgia Institute of Technology
Atlanta, Georgia, 30332
About this study
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:
- 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.
- Use the developed protocol to prospectively plan and evaluate the possible surgical options for new patients.
- Validate that the optimal virtual anatomy agrees with what was surgically implemented using post-operative patient scans, when available.
Read the detailed description
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 optimal approach for reconstruction will be implemented more frequently, and thus patient outcomes will improve.
- Conditions
- Double Outlet Right Ventricle
- Being tested
- Anatomic Reconstruction and Surgical Planning
- Keywords
- congenital heart disease, surgical planning
- Medical subject headings
- Double Outlet Right Ventricle, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomic Reconstruction and Surgical PlanningOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2009 (estimated)
- Study startAug 2009
- Primary completion9 Jan 2019
- Study completion9 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double Outlet Right VentricleStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Slesnick, Emory University
- Investigators
- Kirk Kanter, MD, Principal investigator, Emory University/Children's Healthcare of AtlantaTim Slesnick, MD, Study chair, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972608
- Sponsor's protocol ID
- IRB00014388
- Status last verified
- Dec 2021
- First submitted
- 3 Sep 2009
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Planning for Reconstruction of Complex Heart Defects
- ClinicalTrials.gov ID
- NCT00972608
- Acronym / sponsor ID
- IRB00014388
- Conditions
- Double Outlet Right Ventricle
- Keywords
- congenital heart disease, surgical planning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2009 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 7 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Use the developed protocol to prospectively plan and evaluate the possible surgical options for new patients.
- Validate that the optimal virtual anatomy agrees with what was surgically implemented using post-operative patient scans, when available.
Detailed description
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 optimal approach for reconstruction will be implemented more frequently, and thus patient outcomes will improve.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- upon review by engineers at Georgia Tech, the image quality of the acquired scans is deemed insufficient to reconstruct an accurate 3D model
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomic Reconstruction and Surgical PlanningStandard 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. | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk Kanter, MD principal investigator
Emory University/Children's Healthcare of Atlanta
Tim Slesnick, MD study chair
Children's Healthcare of Atlanta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Double Outlet Right Ventricle, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.