Aortic Valve DiseaseNIMO-TAVINCT05840757
Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation
A study testing HemoSphere ClearSight Module in people with Aortic Valve Disease, run by University of Basel at 1 site in Switzerland.
Trial summary
In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- HemoSphere ClearSight Module
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years old) with severe aortic stenosis undergoing elective TAVI.
Who cannot join
- Emergency indication for TAVI
- Severe tricuspid regurgitation
- Severe mitral stenosis or severe regurgitation
- Invasive right heart catheterization impossible
- Dependency on right ventricle pacing immediately after TAVI implantation
- Vulnerable subjects
Show all 9Show fewer
- Known or suspected non-compliance, drug or alcohol abuse
- Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation affecting this study
- Previous enrolment into the current investigation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation - A Single-center, Prospective, Interventional Study With the ClearSight® Finger Cuff
In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional management.
The aim of this study is to evaluate the effectiveness and safety of a non-invasive hemodynamics monitoring tool called ClearSight for monitoring during TAVI procedures compared with standard invasive measurements.
Read the detailed description
In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional management.
The aim of this study is to evaluate the effectiveness and safety of a non-invasive hemodynamics monitoring tool called ClearSight for monitoring during TAVI procedures compared with standard invasive measurements.
The ClearSight monitoring system works non-invasively by utilizing an inflatable finger cuff which adjusts automatically to measure the arterial blood pressure which enables the calculation of parameters such as cardiac output or index. Multiple studies have demonstrated the reliability and feasibility of continuous non-invasive monitoring, in different settings, however it was never performed in patients undergoing TAVI.
The ClearSight monitoring system will be directly compared to invasive measurements of hemodynamic parameters during the procedure. In addition, information regarding baseline hemodynamics and its changes during/after procedure may give important information on peri- and post-procedural management and short-term outcomes and discharge planning. A tool, providing this information non-invasively with the same accuracy might result in a major improvement in daily practice..
- Conditions
- Aortic Valve Disease
- Being tested
- HemoSphere ClearSight Module
- Keywords
- Transcatheter aortic valve implantation, hemodynamic parameter
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoSphere ClearSight ModuleDevice
The Clear Sight system consists of a finger cuff connected to a monitor It will be applied to the patients finger before and removed after the TAVI procedure.
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic Monitoring | Other | Simultaneous measurement of hemodynamic parameters such as Cardiac output, cardiac index and blood pressure with invasive right heart catheterization and non-invasive application of the Clearsight Finger Cuff. Receives: Device: HemoSphere ClearSight Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
Cardiac Output (CO in L/min)
Measured: During aortic valve implantation which generally takes about 40mins
Cardiac Index
Cardiac Index (CI in L/min/m2)
Measured: During aortic valve implantation which generally takes about 40mins
Systolic blood pressure
systolic blood pressure (sBP in mmHg)
Measured: During aortic valve implantation which generally takes about 40mins
Diastolic blood pressure
diastolic blood pressure (dBP in mmHg)
Measured: During aortic valve implantation which generally takes about 40mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start31 Mar 2023
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Nestelberger, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840757
- Sponsor's protocol ID
- Basel
- Acronym
- NIMO-TAVI
- Status last verified
- May 2024
- First submitted
- 4 Apr 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive MOnitoring in Transcathether Aortic Valve Implantation - A Single-center, Prospective, Interventional Study With the ClearSight® Finger Cuff
- ClinicalTrials.gov ID
- NCT05840757
- Acronym / sponsor ID
- NIMO-TAVI / Basel
- Conditions
- Aortic Valve Disease
- Keywords
- Transcatheter aortic valve implantation, hemodynamic parameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 May 2023 (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.
In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional management.
The aim of this study is to evaluate the effectiveness and safety of a non-invasive hemodynamics monitoring tool called ClearSight for monitoring during TAVI procedures compared with standard invasive measurements.
Detailed description
In patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) minimal evidence is available for invasive hemodynamic monitoring and no evidence for tools able to measure traditionally invasive parameters non-invasively for peri-procedural guidance and post-interventional management.
The aim of this study is to evaluate the effectiveness and safety of a non-invasive hemodynamics monitoring tool called ClearSight for monitoring during TAVI procedures compared with standard invasive measurements.
The ClearSight monitoring system works non-invasively by utilizing an inflatable finger cuff which adjusts automatically to measure the arterial blood pressure which enables the calculation of parameters such as cardiac output or index. Multiple studies have demonstrated the reliability and feasibility of continuous non-invasive monitoring, in different settings, however it was never performed in patients undergoing TAVI.
The ClearSight monitoring system will be directly compared to invasive measurements of hemodynamic parameters during the procedure. In addition, information regarding baseline hemodynamics and its changes during/after procedure may give important information on peri- and post-procedural management and short-term outcomes and discharge planning. A tool, providing this information non-invasively with the same accuracy might result in a major improvement in daily practice..
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic Monitoring | Other | Device: HemoSphere ClearSight ModuleSimultaneous measurement of hemodynamic parameters such as Cardiac output, cardiac index and blood pressure with invasive right heart catheterization and non-invasive application of the Clearsight Finger Cuff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (>18 years old) with severe aortic stenosis undergoing elective TAVI.
Key exclusion criteria (9 listed)
- Emergency indication for TAVI
- Severe tricuspid regurgitation
- Severe mitral stenosis or severe regurgitation
- Invasive right heart catheterization impossible
- Dependency on right ventricle pacing immediately after TAVI implantation
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 |
|---|---|---|
| HemoSphere ClearSight ModuleThe Clear Sight system consists of a finger cuff connected to a monitor It will be applied to the patients finger before and removed after the TAVI procedure. | Device | Hemodynamic Monitoring |
Primary outcome
Cardiac Output
Time frame: During aortic valve implantation which generally takes about 40mins
Cardiac Output (CO in L/min)
Cardiac Index
Time frame: During aortic valve implantation which generally takes about 40mins
Cardiac Index (CI in L/min/m2)
Systolic blood pressure
Time frame: During aortic valve implantation which generally takes about 40mins
systolic blood pressure (sBP in mmHg)
Diastolic blood pressure
Time frame: During aortic valve implantation which generally takes about 40mins
diastolic blood pressure (dBP in mmHg)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HemoSphere ClearSight Module in people with Aortic Valve Disease, run by University of Basel at 1 site in Switzerland.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 14 May 2024. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (time frame: During aortic valve implantation which generally takes about 40mins). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2024.