Clinical trial NCT03088787: Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis
Official title: Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Stenosis, Calcific
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2017-03-23
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) procedures

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.


Eligibility criteria: 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

Primary outcomes:
measure: the distinctive morphological characteristics of the aortic pressure waveform
timeFrame: During procedure and 4 hours after
Secondary outcomes:
measure: changes in hemodynamic variables after TAVR and its influence on cardiac recovery.
timeFrame: during procedure and up to 6 weeks after intervention
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Veelo
Study officials:
References:
citation: Schenk J, Kho E, Rellum S, Kromhout J, Vlaar APJ, Baan J, van Mourik MS, Jorstad HT, van der Ster BJP, Westerhof BE, Bruns S, Immink RV, Vis MM, Veelo DP. Immediate reduction in left ventricular ejection time following TAVI is associated with improved quality of life. Front Cardiovasc Med. 2022 Sep 16;9:988840. doi: 10.3389/fcvm.2022.988840. eCollection 2022.