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Status unknownNCT05374733POTUSUpdated May 16, 2022

Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions

An interventional study of Coronary Physiology assessment in Aortic Valve Stenosis, Mitral Regurgitation and Coronary Artery Disease, sponsored by Erasmus Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-16.

Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2021, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Aortic Valve Stenosis
  • Mitral Regurgitation
  • Coronary Artery Disease
  • Fractional Flow Reserve

Keywords

  • Coronary Physiology
03

In context

Aortic Valve Stenosis

1,006 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.

This study's planned enrollment of 150 is above the median of 120 across 537 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.

Browse Erasmus Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18.

  • a) TAVI cohort: severe aortic valve stenosis for which TAVI is scheduled after discussion in the Heart Team.

    b) 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Other
    Single arm

    Coronary physiology measurements both pre- and post- transcatheter left-sided valvular intervention.

    Diagnostic Test: Coronary Physiology assessment

Interventions

  • Diagnostic testCoronary Physiology assessment

    1. 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.

06

What researchers measure

Primary outcomes

  1. The change in the FFR value before and after TAVI

    The impact of TAVI on FFR

    Time frame: Directly before and after the TAVI procedure (1 hour)

  2. The change in the FFR value before and after TMVr

    The impact of TMVr on FFR

    Time frame: Directly before and after the TMVr procedure (1 hour)

Secondary outcomes

  1. The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr)

    The impact of TAVI/TMVr on RFR

    Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)

  2. The change in dPR before and after transcatheter valvular intervention (either TAVI or TMVr)

    The impact of TAVI/TMVr on dPR

    Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)

  3. The change in Pd/Pa before and after transcatheter valvular intervention (either TAVI or TMVr)

    The impact of TAVI/TMVr on Pd/Pa

    Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)

  4. The change in CFR before and after transcatheter valvular intervention (either TAVI or TMVr)

    The impact of TAVI/TMVr on CFR

    Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)

  5. The change in IMR before and after transcatheter valvular intervention (either TAVI or TMVr)

    The impact of TAVI/TMVr on IMR

    Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)

  6. The change in transvalvular gradient before and after transcatheter valvular intervention (either TAVI or TMVr)

    The impact of TAVI/TMVr on the transvalvular gradient

    Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)

  7. 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

    Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)

  8. The change in systemic aortic pressure before and after transcatheter valvular intervention (either TAVI or TMVr)

    The impact of TAVI/TMVr on hemodynamics

    Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)

  9. The change in heart rate before and after transcatheter valvular intervention (either TAVI or TMVr)

    The impact of TAVI/TMVr on hemodynamics

    Time frame: Directly before and after the TAVI/TMVr procedure (1 hour)

Other outcomes

  1. The difference in the mean change in the FFR between the TAVI cohort and the TMVR cohort.

    The mean change in the FFR in TAVI patients will be compared to mean change in FFR in TMVr patients.

    Time frame: Baseline

  2. The difference in the mean change in the RFR between the TAVI cohort and the TMVR cohort.

    The mean change in the RFR in TAVI patients will be compared to mean change in RFR in TMVr patients.

    Time frame: Baseline

  3. The difference in the mean change in the dPR between the TAVI cohort and the TMVR cohort.

    The mean change in the dPR in TAVI patients will be compared to mean change in dPR in TMVr patients.

    Time frame: Baseline

  4. The difference in the mean change in the Pd/Pa between the TAVI cohort and the TMVR cohort.

    The mean change in the Pd/Pa in TAVI patients will be compared to mean change in Pd/Pa in TMVr patients.

    Time frame: Baseline

  5. The number of patients in who the post FFR, RFR, Pd/Pa or dPR value crosses the border of hemodynamic significance as compared to the value pre-valvular intervention.

    Number of patients who have 1) a positive FFR/RFR/Pd/Pa/dPR value pre-valvular intervention, and negative FFR/RFR/Pd/Pa/dPR post-valvular intervention or 2) a negative FFR/RFR/Pd/Pa/dPR pre-valvular intervention, and positive FFR/RFR/Pd/Pa/dPR value post-valvular intervention.

    Time frame: Baseline

  6. The number of patients in whom the decision for coronary revascularization is altered when based on the post-procedural FFR value instead of angiographic stenosis severity.

    Number of patients who have 1) post-valvular intervention FFR ≤ 0.80 and diameter stenosis 50-70% or 2) post-valvular intervention FFR \> 0.80 and diameter stenosis ≥ 70%.

    Time frame: Baseline

  7. The diagnostic performance of vessel FFR (vFFR; an angiography-based FFR index) in the setting of valvular heart disease.

    The vFFR pre-intervention will be validated against the FFR-value both pre- and post-intervention

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Erasmus MC
    Rotterdam, 3015GD, Netherlands
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2021 (actual). Primary completion is estimated for Mar 2023, 23 months after the start.

Of 174 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 23 months is below that.

Counting every sponsor, half of 277 studies reached it within 33 months; a quarter within 19 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2021
First posted
May 16, 2022
StartActual
Mar 22, 2021
Primary completionEst.
Mar 1, 2023
CompletionEst.
Mar 1, 2023
Last update
May 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05374733
Lead sponsor
Erasmus Medical Center
Responsible party
Nicolas van Mieghem (Prof. Dr. Nicolas M. Van Mieghem, Erasmus Medical Center) — Principal investigator
First posted
May 16, 2022
Start date
Mar 22, 2021
Primary completion
Mar 1, 2023 (estimated)
Completion
Mar 1, 2023 (estimated)
Last update
May 16, 2022

Study contacts

Nicolas M van Mieghem, MD, PhD
Contact
n.vanmieghem@erasmusmc.nl
+31 (0)10 70 352 60
Nicolas M van Mieghem, MD, PhD
principal investigator · Erasmus Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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