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Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients

Study acronym: SAVI-AoS
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record status
This record was last updated February 14, 2024 (before its estimated October 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Apr 14, 2027 to Oct 1, 2024v8 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 52
    • Study sites: 7 to 5
    • Study completion date: Apr 14, 2027 to Oct 1, 2028
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Notable Primary completion date: Apr 14, 2022 to Apr 14, 2027
    • Study sites: 1 to 7
    v6
  4. Notable Primary endpoints: 1 to 3
    • Secondary endpoints: 1 to 2
    v5
  5. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Mar 1, 2022 to Apr 14, 2022
    • Study completion date: Mar 1, 2026 to Apr 14, 2027
    • Start date changed from estimate of Mar 1, 2021 to Apr 14, 2021
    • Eligibility criteria revised
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Start date: Oct 1, 2020 to Mar 1, 2021
    • Primary completion date: Oct 1, 2022 to Mar 1, 2022
    • Study completion date: Oct 1, 2026 to Mar 1, 2026
    • Eligibility criteria expanded, about 19 words
    v3
  2. Minor Eligibility criteria expanded, about 4 wordsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 an echocardiogram yearly as suggested by guideline criteria and could possibly be contacted until five years after enrollment. Blood samples will be drawn at baseline and the 1-year follow-up. Potentially the new SAVI metric could identify patients at higher risk among those with moderate gradient AS. However, since no outcome data currently exists regarding SAVI and prognosis, no conclusions could be derived from these measurements until study completion.
Trial Details
NCT Number NCT04514250
Lead Sponsor Catharina Ziekenhuis Eindhoven
Conditions
(from sponsor)
Aortic Valve Stenosis
Related terms Aortic Valve Stenosis
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov