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

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Stenosis, Calcific
• Intervention / Treatment: Device: Nexfin measuremtents

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Veelo
    • Contact: Denise Veelo; Phone Number: +31205669111; Email: d.p.veelo@amc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) procedures

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients for TAVR	Device: Nexfin measuremtents; There will be only observational recordings, no interevntion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Edwards Lifesciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: W17_072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No