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X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development

X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00965679
Enrollment
1
Registered
2009-08-25
Start date
2009-08-06
Completion date
2010-05-27
Last updated
2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

Cardiac CT, Iodinated Radiocontrast, Ionizing Radiation, Aortic Valve Stenosis, Percutaneous Aortic Valve Replacement, Heart Valve

Brief summary

Background: * Computed tomography (CT) creates three-dimensional images based on X-ray imaging. CT is useful for determining treatment approaches for certain diseases, such as calcific aortic stenosis (narrowing of the aorta because of calcium deposits). * Comparing the data received from CT scans with the data received from heart catheterization (which assesses the heart's condition and function) can be used to improve treatment in patients with certain heart conditions. Researchers are interested in looking at the effectiveness of both procedures in assessing possible surgical treatments for patients with calcific aortic stenosis. Objectives: \- To analyze cardiac CT scans in conjunction with existing heart scan results to improve treatments for future minimally invasive aortic valve replacement. Eligibility: \- Patients 18 years of age and older who have been diagnosed with aortic valve stenosis that may be treated surgically, and who will undergo or have recently undergone heart catheterization. Design: * Participants will have a CT scan within 90 days of the medically necessary heart catheterization, but before any other surgical or catheter treatment. * During the CT scan, patients will be asked to hold their breath intermittently for about 5 to 20 seconds. Patients will be inside the scanner for less than 30 minutes. * Patients will be asked to return in 3 to 7 days for a blood test to check kidney function. * Researchers will analyze the results of the CT scan in conjunction with the previous results from the catheterization to determine possible improved treatment options.

Detailed description

We will collect cardiac computed tomography (CT) data from patients with aortic valve stenosis being considered for surgical or catheter treatment. These data will be analyzed along with medically-necessary fluoroscopy from cardiac catheterization to learn whether they can be combined to enhance future minimally invasive valve treatments.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
Lead SponsorNIH

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* INCLUSION CRITERIA: SELECTION CRITERIA: PATHWAY FOR RESEARCH CT: * Adult patients age 18 years or older * Having calcific aortic stenosis being considered for surgical or catheter-based treatment, determined on physical examination or noninvasive imaging such as echocardiography * Undergoing diagnostic cardiac catheterization within 1 year * Able to provide informed consent ALTERNATIVE SELECTION CRITERIA: PATHWAY FOR ANALYSIS OF MEDICAL DATA: * Adult patients age 18 years or older * Having calcific aortic stenosis being considered for surgical or catheter-based treatment, determined on physical examination or noninvasive imaging such as echocardiography * Undergoing diagnostic cardiac catheterization within 1 year * Having undergone cardiac CT for medical indications meeting the technical requirements of this protocol * Able to provide informed consent

Exclusion criteria

SELECTION CRITERIA: PATHWAY FOR RESEARCH CT: * Pregnant or lactating women * Decompensated heart failure (unable to lie flat during CT)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026