Aortic Valve StenosisPOTUSNCT05374733
Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions
A study testing Coronary Physiology assessment in people with Aortic Valve Stenosis and Mitral Regurgitation, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Mitral Regurgitation, Coronary Artery Disease
- What is being tested?
- Coronary Physiology assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Mar 2021to 1 Mar 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
- Age ≥ 18.
- a) TAVI cohort: severe aortic valve stenosis for which TAVI is scheduled after discussion in the Heart Team.
- TMVr cohort: severe functional/degenerative mitral regurgitation for which TMVr is scheduled after discussion in the Heart Team.
- At least intermediate coronary artery disease, defined as 50-99% diameter stenosis in a vessel ≥ 2.5 mm
- Elective procedure
- Written informed consent
Who cannot join
- TAVI cohort: height coronary ostia < 10 mm
- Severe chronic kidney disease, defined as estimated glomerular filtration rate < 30 ml/min.
- Contra-indication for intravenous adenosine: severe asthma or chronic obstructive pulmonary disease, known allergy to adenosine or previous reported bronchospasm in response to adenosine.
- Degenerated surgical or transcatheter aortic valve bioprosthesis.
- Vessels that have collaterals to a chronic total occlusion or that are supplied by an arterial or venous bypass graft will not be interrogated in this study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, 3015GD
Nicolas M van Mieghem, MD, PhD, +31(0)107035260, n.vanmieghem@erasmusmc.nl
About this study
Official title: Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions in Patients With Severe Aortic Stenosis or Mitral Regurgitation
Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.
Read the detailed description
The POTUS study is a prospective, investigator-initiated, single-arm observational study with invasive measurements that will consist of two cohorts. The first cohort consists of 120 patients with intermediate coronary artery disease who undergo a transcatheter aortic valve implantation (TAVI) for severe aortic valve stenosis ('TAVI cohort'). The second cohort consists of 30 patients with intermediate coronary artery disease who undergo transcatheter mitral valve repair (TMVr) for functional/degenerative mitral regurgitation ('TMVr cohort'). Both cohorts will undergo a battery of coronary physiological tests both before and after the valvular intervention. Additionally, in the case that the fractional flow reserve (FFR) over a coronary lesion is significant (i.e. FFR ≤ 0.80) during the post valvular intervention measurements, additional percutaneous coronary intervention (PCI) will take place during the same procedure.
- Conditions
- Aortic Valve Stenosis, Mitral Regurgitation, Coronary Artery Disease, Fractional Flow Reserve
- Being tested
- Coronary Physiology assessment
- Keywords
- Coronary Physiology
- Medical subject headings
- Aortic Valve Stenosis, Mitral Valve Insufficiency, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Physiology assessmentDiagnostic test
- Pd/Pa, diastolic pressure ratio (dPR), resting full cycle ratio (RFR), FFR, coronary flow reserve (CFR), and index of microvascular resistance (IMR) measurements in the coronary of interest before the valvular intervention.
- Pd/Pa, dPR, RFR, FFR, vFFR, CFR and IMR measurements in the coronary of interest after the valvular intervention.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Coronary physiology measurements both pre- and post- transcatheter left-sided valvular intervention. Receives: Diagnostic Test: Coronary Physiology assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the FFR value before and after TAVI
The impact of TAVI on FFR
Measured: Directly before and after the TAVI procedure (1 hour)
The change in the FFR value before and after TMVr
The impact of TMVr on FFR
Measured: Directly before and after the TMVr procedure (1 hour)
Secondary outcomes (9)
The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on RFR
Measured: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in dPR before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on dPR
Measured: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in Pd/Pa before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on Pd/Pa
Measured: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in CFR before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on CFR
Measured: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in IMR before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on IMR
Measured: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in transvalvular gradient before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on the transvalvular gradient
Measured: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in left ventricular end-diastolic pressure (LVEDP) before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on the LVEDP
Measured: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in systemic aortic pressure before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on hemodynamics
Measured: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in heart rate before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on hemodynamics
Measured: Directly before and after the TAVI/TMVr procedure (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start22 Mar 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-arm, observational study with invasive measurements in two cohorts (TAVI cohort and TMVr cohort).
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas van Mieghem, Erasmus Medical Center
- Investigators
- Nicolas M van Mieghem, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374733
- Sponsor's protocol ID
- POTUS
- Acronym
- POTUS
- Status last verified
- May 2022
- First submitted
- 21 Sep 2021
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions in Patients With Severe Aortic Stenosis or Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT05374733
- Acronym / sponsor ID
- POTUS / POTUS
- Conditions
- Aortic Valve Stenosis, Mitral Regurgitation, Coronary Artery Disease, Fractional Flow Reserve
- Keywords
- Coronary Physiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 16 May 2022 (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.
Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.
Detailed description
The POTUS study is a prospective, investigator-initiated, single-arm observational study with invasive measurements that will consist of two cohorts. The first cohort consists of 120 patients with intermediate coronary artery disease who undergo a transcatheter aortic valve implantation (TAVI) for severe aortic valve stenosis ('TAVI cohort'). The second cohort consists of 30 patients with intermediate coronary artery disease who undergo transcatheter mitral valve repair (TMVr) for functional/degenerative mitral regurgitation ('TMVr cohort'). Both cohorts will undergo a battery of coronary physiological tests both before and after the valvular intervention. Additionally, in the case that the fractional flow reserve (FFR) over a coronary lesion is significant (i.e. FFR ≤ 0.80) during the post valvular intervention measurements, additional percutaneous coronary intervention (PCI) will take place during the same procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, observational study with invasive measurements in two cohorts (TAVI cohort and TMVr cohort).
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Diagnostic Test: Coronary Physiology assessmentCoronary physiology measurements both pre- and post- transcatheter left-sided valvular intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18.
- a) TAVI cohort: severe aortic valve stenosis for which TAVI is scheduled after discussion in the Heart Team.
- At least intermediate coronary artery disease, defined as 50-99% diameter stenosis in a vessel ≥ 2.5 mm
- Elective procedure
- Written informed consent
Key exclusion criteria (5 listed)
- TAVI cohort: height coronary ostia < 10 mm
- Severe chronic kidney disease, defined as estimated glomerular filtration rate < 30 ml/min.
- Contra-indication for intravenous adenosine: severe asthma or chronic obstructive pulmonary disease, known allergy to adenosine or previous reported bronchospasm in response to adenosine.
- Degenerated surgical or transcatheter aortic valve bioprosthesis.
- Vessels that have collaterals to a chronic total occlusion or that are supplied by an arterial or venous bypass graft will not be interrogated in this study.
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 |
|---|---|---|
| Coronary Physiology assessment1. Pd/Pa, diastolic pressure ratio (dPR), resting full cycle ratio (RFR), FFR, coronary flow reserve (CFR), and index of microvascular resistance (IMR) measurements in the coronary of interest before the valvular intervention. 2. Pd/Pa, dPR, RFR, FFR, vFFR, CFR and IMR measurements in the coronary of interest after the valvular intervention. | Diagnostic test | Single arm |
Primary outcome
The change in the FFR value before and after TAVI
Time frame: Directly before and after the TAVI procedure (1 hour)
The impact of TAVI on FFR
The change in the FFR value before and after TMVr
Time frame: Directly before and after the TMVr procedure (1 hour)
The impact of TMVr on FFR
9 secondary outcomes
The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr)
Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in dPR before and after transcatheter valvular intervention (either TAVI or TMVr)
Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in Pd/Pa before and after transcatheter valvular intervention (either TAVI or TMVr)
Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in CFR before and after transcatheter valvular intervention (either TAVI or TMVr)
Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in IMR before and after transcatheter valvular intervention (either TAVI or TMVr)
Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in transvalvular gradient before and after transcatheter valvular intervention (either TAVI or TMVr)
Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in left ventricular end-diastolic pressure (LVEDP) before and after transcatheter valvular intervention (either TAVI or TMVr)
Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in systemic aortic pressure before and after transcatheter valvular intervention (either TAVI or TMVr)
Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)
The change in heart rate before and after transcatheter valvular intervention (either TAVI or TMVr)
Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- 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.
Nicolas M van Mieghem, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Physiology assessment in people with Aortic Valve Stenosis and Mitral Regurgitation, run by Erasmus Medical Center 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 6 inclusion and 5 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 16 May 2022. 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?
Contact Nicolas M van Mieghem, MD, PhD (+31 (0)10 70 352 60, n.vanmieghem@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the FFR value before and after TAVI (time frame: Directly before and after the TAVI procedure (1 hour)). The study lists 2 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 16 May 2022.