Aortic Stenosis, CalcificCOaRtNCT03088787
Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis
An observational study of Aortic Stenosis, Calcific, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis, Calcific
- What is being tested?
- Nexfin measuremtents
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2017to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) procedures
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Veelo
Amsterdam
Denise Veelo, +31205669111, d.p.veelo@amc.nl
About this study
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.
- Conditions
- Aortic Stenosis, Calcific
- Being tested
- Nexfin measuremtents
- Medical subject headings
- Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexfin measuremtentsDevice
There will be only observational recordings, no interevntion
| Study group | Role | What they receive |
|---|---|---|
| Patients for TAVR | Patients for TAVR Receives: Device: Nexfin measuremtents |
What is being measured
The primary outcome is the main question the study is designed to answer.
the distinctive morphological characteristics of the aortic pressure waveform
the distinctive morphological characteristics of the aortic pressure waveform
Measured: During procedure and 4 hours after
Secondary outcomes (1)
changes in hemodynamic variables after TAVR and its influence on cardiac recovery.
Measured: during procedure and up to 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Apr 2017
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Stenosis, CalcificStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, D.P.Veelo, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088787
- Sponsor's protocol ID
- W17_072
- Acronym
- COaRt
- Status last verified
- May 2018
- First submitted
- 17 Mar 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 38509415Schenk 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.
PubMed 36187009
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis
- ClinicalTrials.gov ID
- NCT03088787
- Acronym / sponsor ID
- COaRt / W17_072
- Conditions
- Aortic Stenosis, Calcific
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients for TAVR | – | Device: Nexfin measuremtentsPatients for TAVR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) procedures
Key inclusion criteria (8 listed)
- o Patients with severe senile degenerative aortic valve stenosis
Key exclusion criteria (7 listed)
- o Patients with contraindications for placement of aortic catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexfin measuremtentsThere will be only observational recordings, no interevntion | Device | Patients for TAVR |
Primary outcome
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
1 secondary outcome
changes in hemodynamic variables after TAVR and its influence on cardiac recovery.
Time frame: during procedure and up to 6 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Derived from this study: PubMed 38509415Kho 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.
- Derived from this study: PubMed 36187009Schenk 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.
- Individual participant dataSharing planned: Yes
Related trials for Aortic Stenosis, Calcific
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Active, not recruiting
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
Aortic Stenosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression
Calcific Aortic Valve Disease, AORTIC VALVE DISEASES
Active, not recruiting
DurAVR™ THV EU-EFS
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, Calcific, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the distinctive morphological characteristics of the aortic pressure waveform (time frame: During procedure and 4 hours after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03088787, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.