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Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients
NCT04514250 · View on ClinicalTrials.gov ↗
Study Summary
Discrepancies exist among aortic stenosis severity classification, patient symptom burden, and - in some cases - even survival. The new Stress Aortic Valve Index (SAVI) metric correlates better with transvalvular flow and might be a better predictor of symptoms and prognosis. The current study will demonstrate the value of SAVI (both non-invasive and invasive) in patients with moderate aortic stenosis. The population will consist of subjects at least 50 years old with moderate aortic stenosis (defined as aortic valve area \>1.0 cm2 plus either maximal velocity 2.5-3.9 m/s or mean gradient 15-39 mmHg). Subjects with severe concomitant valve disease or severe unrevascularized coronary artery disease will be excluded, so that the isolated prognosis of aortic stenosis can be investigated. All subjects will undergo invasive SAVI measurements during catheterization. Furthermore patients will receive non-invasive testing with an exercise echocardiogram and computed tomography (CT) scan for non-invasive SAVI measurements. The short-term objective will compare SAVI with standard resting indexes for symptom burden, functional capacity, and biomarkers. The long-term objective will associate SAVI and standard resting indexes with clinical outcomes related to valvular disease. The investigators hypothesize that low SAVI (more marked AS during stress) will track with more symptoms and a worse prognosis. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The patients will have several study visits. The index visit will be planned to obtain informed consent and baseline parameters. The measurement visit(s) will consist of the invasive SAVI measurement, echocardiogram, stress echo imaging, 6-minute walk test, quality of life questionnaire, and the cardiac CT. During the final visit after 12 months, subjects will undergo a CT valvular calcium scan, quality of life questionnaire, and 6-minute walk test. Every subject will have
Conditions Studied
Study Locations (5)
Other
- Aalborg University Hospital — Aalborg
- Catharina Hospital Eindhoven — Eindhoven
- Erasmus University Medical Center — Rotterdam
Massachusetts
- UMass Medical Memorial Center — Worcester
Texas
- UTHealth Houston, McGovern Medical School — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-04-14 |
| Est. Completion | 2028-10-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04514250
The ClinicalTrials.gov registry entry for NCT04514250 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Catharina Ziekenhuis Eindhoven, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04514250 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Other, Massachusetts, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04514250 about?
NCT04514250 is a clinical study titled "Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients". Discrepancies exist among aortic stenosis severity classification, patient symptom burden, and - in some cases - even survival. The new Stress Aortic Valve Index (SAVI) metric correlates better with transvalvular flow and might be a better predictor of symptoms and prognosis. The current study will...
What is the current status of trial NCT04514250?
This trial is currently active not recruiting. The enrollment target is 52 participants. The study started on 2021-04-14. Estimated completion is 2028-10-01.
What conditions does trial NCT04514250 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT04514250?
This trial is sponsored by Catharina Ziekenhuis Eindhoven, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04514250 being conducted?
This trial has 5 study locations across Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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