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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03088787
Other study ID # W17_072
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04889872 - PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR N/A
Active, not recruiting NCT03585933 - Prognostic Value of Myocardial Fibrosis in Severe Aortic Valve Stenosis
Completed NCT03923530 - Pressure Assessment to Improve Outcomes After TAVR: a Registry Early Phase 1
Recruiting NCT04242225 - Accuracy of Using 2D Transesophageal Echocardiography Compared to Balloon Sizing in Determining Valve Size During Transcatheter Aortic Valve Implantation