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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-06

Study Completion Date

2010-05-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HeartFlowNXT - HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography

NCT01757678

Coronary Artery Disease

COMPLETED NA

Study of Coronary Artery Disease by Two Types of Angiography

NCT00273819

Congestive Heart Failure

COMPLETED NA

Evaluating New Radiation Techniques for Cardiovascular Imaging

NCT01621594

Coronary Disease

RECRUITING NA

Visual Estimation of Coronary Fractional Flow Reserve From High-definition Computed Tomographic Coronary Angiography

NCT02179957

Stenoses Ischaemia

COMPLETED

Non-Contrast Magnetic Resonance Angiography Assessment of Patients Referred for Transcatheter Aortic Valve Implantation

NCT02007967

Aortic Valve Stenosis

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Valve Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

* Advanced atrioventricular block (Mobitz Type II second degree or third degree atrioventricular heart block)
* Asthma or chronic obstructive pulmonary disease (emphysema) currently treated with beta adrenergic agonists

-Severe kidney disease (MDRD estimated Glomerular Filtration Rate

\< 30mL/min/l.73m(2)).

-Request of referring physician or surgeon not to administer iodinated radiocontrast

ALTERNATIVE SELECTION CRITERIA: PATHWAY FOR ANALYSIS OF MEDICAL DATA:

-None

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No