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

• Conditions: Aortic Stenosis, Calcific
• Interventions: Device: Nexfin measuremtents

• Registration Number: NCT03088787
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-23
• Study Start: 2017-04-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-08
• Primary Completion: 2018-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients for TAVR	Nexfin measuremtents	Patients for TAVR

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
changes in hemodynamic variables after TAVR and its influence on cardiac recovery.	during procedure and up to 6 weeks after intervention

Trial Locations

Locations (1)

Veelo; 🇳🇱 Amsterdam, Netherlands