Aortic Stenosis, Calcific
Conditions
Brief summary
The primary purpose of this study is electronic data collection of arterial pressure waveform signals in patients with Aortic Stenosis. The collected digital pressure waveform data will be used to assess the feasibility of using the arterial pressure signal as a decision support tool for early detection of aortic stenosis conditions. Furthermore we evaluate hemodynamic parameters before and after valve repair and its correlation with outcome.
Interventions
DEVICENexfin measuremtents
There will be only observational recordings, no interevntion
Sponsors
Edwards Lifesciences
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* o Patients with severe senile degenerative aortic valve stenosis * Clinical team agrees on eligibility including assessment that TAVR is appropriate for the subject * Patients undergoing TAVR via the femoral approach * Patients who normally require a guiding catheter for central aortic pressure monitoring during the TAVR procedure * Patient must be 18 years old or older * Patient, or legally authorized representative, has given consent to be in the study * Patient height and weight are available prior to study * Ability to perform a Nexfin measurement at the left hand side.
Exclusion criteria
* o Patients with contraindications for placement of aortic catheter * Patients with mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+). * Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is noncalcified * Patients being treated with an intra-aortic balloon pump * Patients less than 40 kg in weight * Female patients of childbearing potential with a known pregnancy * Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the distinctive morphological characteristics of the aortic pressure waveform | During procedure and 4 hours after | the distinctive morphological characteristics of the aortic pressure waveform |
Secondary
| Measure | Time frame |
|---|---|
| changes in hemodynamic variables after TAVR and its influence on cardiac recovery. | during procedure and up to 6 weeks after intervention |
Countries
Netherlands
Outcome results
None listed