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Trial record 5 of 227 for:    Recruiting, Not yet recruiting, Available Studies | Aortic stenosis

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

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ClinicalTrials.gov Identifier: NCT03088787
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
D.P.Veelo, 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.

Condition or disease Intervention/treatment
Aortic Stenosis, Calcific Device: Nexfin measuremtents

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. the distinctive morphological characteristics of the aortic pressure waveform [ Time Frame: During procedure and 4 hours after ]
    the distinctive morphological characteristics of the aortic pressure waveform


Secondary Outcome Measures :
  1. changes in hemodynamic variables after TAVR and its influence on cardiac recovery. [ Time Frame: during procedure and up to 6 weeks after intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) procedures
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088787


Locations
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Netherlands
Veelo Recruiting
Amsterdam, Netherlands
Contact: Denise Veelo    +31205669111    d.p.veelo@amc.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Edwards Lifesciences

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Responsible Party: D.P.Veelo, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03088787     History of Changes
Other Study ID Numbers: W17_072
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Calcinosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Calcium Metabolism Disorders
Metabolic Diseases