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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04514250




Registration number
NCT04514250
Ethics application status
Date submitted
12/08/2020
Date registered
14/08/2020
Date last updated
13/10/2023

Titles & IDs
Public title
Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients
Scientific title
Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients
Secondary ID [1] 0 0
SAVI-AoS NL74875.100.20
Universal Trial Number (UTN)
Trial acronym
SAVI-AoS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of the valve metrics vs baseline clinical parameters (KCCQ)
Timepoint [1] 0 0
1 to 5 years
Primary outcome [2] 0 0
Evaluation of the valve metrics vs baseline clinical parameters (6MWT)
Timepoint [2] 0 0
1 to 5 years
Primary outcome [3] 0 0
Evaluation of the valve metrics vs baseline clinical parameters (biomarkers)
Timepoint [3] 0 0
1 to 5 years
Secondary outcome [1] 0 0
Correlation between invasive (cardiac catherization) and non-invasive (stress echocardiography; computational fluid dynamics obtained from CT scan data) SAVI measurements
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
SAVI vs. clinical outcome (number of hospitalizations (hear failure/angina/syncope/rhythm disturbances/valvular intervention/any death/cardiac death)
Timepoint [2] 0 0
1 to 5 years

Eligibility
Key inclusion criteria
- Age = 50 years

- Moderate aortic stenosis confirmed in the past 3 months by standard echocardiographic
evaluation: aortic valve area >1.0 cm2 plus either maximal velocity 2.5-3.9 m/s or
mean gradient 15-39 mmHg

- Ability to undergo exercise stress testing

- Ability to understand and the willingness to provide written informed consent
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
A potential subject who meets any of the following criteria will be excluded from
participation in this study

- Any hemodynamic criterion for severe AS: maximal velocity >= 4 m/s, mean gradient >=
40mmHg, aortic valve area =< 1 cm2

- Percutaneous coronary intervention or coronary artery bypass grafting in the past
three months, or have revascularization planned in the near future

- Known, unrevascularized, and severe coronary artery disease (for example a 90%
diameter stenosis or FFR<0.7 in the proximal left anterior descending artery)

- Impaired left ventricular function (ejection fraction <50%)

- Unicuspid, bicuspid, or non-calcified aortic valve observed during echocardiography
(note that later cusp fusion noted during study-related cardiac imaging will not
exclude a subject)

- Severe aortic regurgitation, mitral valve disease, tricuspid regurgitation, or a
significant intracardiac shunt

- Co-existing hypertrophic cardiomyopathy or severe septal hypertrophy >15mm

- Persistent atrial fibrillation with uncontrolled ventricular response

- Recent (within 6 weeks) acute coronary syndrome

- Estimated glomerular filtration rate =30 mL/min or end-stage renal disease on
replacement therapy (dialysis)

- Severe COPD GOLD stage 3 or 4, home oxygen dependence, or =2 pulmonary inhalers (note
that well-treated and stable asthma and GOLD stage 1 or 2 COPD is permitted)

- Severe comorbid condition with life expectancy <2 years

- Prior adverse reaction to dobutamine

- Severe iodine contrast allergy

- Pregnancy

- Severe pulmonary hypertension with systolic pulmonary artery pressure greater than
50mmHg or isolated and symptomatic right ventricular failure

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/04/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Fiona Stanley Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Denmark
State/province [3] 0 0
Aalborg
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul
Country [5] 0 0
Netherlands
State/province [5] 0 0
Eindhoven
Country [6] 0 0
Netherlands
State/province [6] 0 0
Rotterdam

Funding & Sponsors
Primary sponsor type
Other
Name
Catharina Ziekenhuis Eindhoven
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 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 website
https://clinicaltrials.gov/ct2/show/NCT04514250
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04514250