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Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | Coronary physiology measurements both pre- and post- transcatheter left-sided valvular intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Physiology assessment | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in the FFR value before and after TAVI | The impact of TAVI on FFR | 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 | Directly before and after the TMVr procedure (1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr) | The impact of TAVI/TMVr on RFR | Directly before and after the TAVI/TMVr procedure (1 hour) |
| The change in dPR before and after transcatheter valvular intervention (either TAVI or TMVr) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| The difference in the mean change in the RFR between the TAVI cohort and the TMVR cohort. |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas M van Mieghem, MD, PhD | Contact | +31 (0)10 70 352 60 | n.vanmieghem@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas M van Mieghem, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Recruiting | Rotterdam | 3015GD | Netherlands |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D008944 | Mitral Valve Insufficiency |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Prospective, single-arm, observational study with invasive measurements in two cohorts (TAVI cohort and TMVr cohort).
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|
The impact of TAVI/TMVr on dPR |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | Directly before and after the TAVI/TMVr procedure (1 hour) |
The mean change in the RFR in TAVI patients will be compared to mean change in RFR in TMVr patients. |
| Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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%. | Baseline |
| 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 | Baseline |
| D014694 |
| Ventricular Outflow Obstruction |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |