Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis

Aortic Stenosis, Calcific Clinical Trial

— COaRt  

Official title:

Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03088787
• Other study ID #: W17_072
• Status: Recruiting
• Start date: April 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis, Calcific
• Aortic Valve Stenosis
• Calcinosis
• Constriction, Pathologic

Intervention

Device:
• Nexfin measuremtents
There will be only observational recordings, no interevntion

Locations

Country	Name	City	State
Netherlands	Veelo	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Edwards Lifesciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the distinctive morphological characteristics of the aortic pressure waveform	the distinctive morphological characteristics of the aortic pressure waveform	During procedure and 4 hours after
Secondary	changes in hemodynamic variables after TAVR and its influence on cardiac recovery.		during procedure and up to 6 weeks after intervention