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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04514250
Ethics application status
Date submitted
12/08/2020
Date registered
14/08/2020

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?
No
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
Active, not 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
1/10/2028
Actual
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
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
Netherlands
State/province [4] 0 0
Eindhoven
Country [5] 0 0
Netherlands
State/province [5] 0 0
Rotterdam

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04514250