NCT03088787

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

March 17, 2017

Last Update Submit

May 3, 2018

Conditions

Aortic Stenosis, Calcific

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • changes in hemodynamic variables after TAVR and its influence on cardiac recovery.

    during procedure and up to 6 weeks after intervention

Study Arms (1)

Patients for TAVR

Patients for TAVR

Device: Nexfin measuremtents

Interventions

Nexfin measuremtentsDEVICE

There will be only observational recordings, no interevntion

Patients for TAVR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veelo

Amsterdam, Netherlands

RECRUITING

Related Publications (2)

  • Kho E, Schenk J, Vlaar APJ, Vis MM, Wijnberge M, Stam LB, van Mourik M, Jorstad HT, Hermanns H, Westerhof BE, Veelo DP, van der Ster BJP. Detecting aortic valve stenosis based on the non-invasive blood pressure waveform-a proof of concept study. Geroscience. 2024 Dec;46(6):5955-5965. doi: 10.1007/s11357-024-01136-w. Epub 2024 Mar 20.

    PMID: 38509415DERIVED

  • 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.

    PMID: 36187009DERIVED

MeSH Terms

Conditions

Aortic Valve, Calcification of

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 17, 2017

First Posted

March 23, 2017

Study Start

April 1, 2017

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

May 8, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Locations

NL(1)