Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions

Study Overview
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Brief Summary
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Prospective, single-arm, observational study with invasive coronary physiology measurements before and after transcatheter left-sided valvular intervention.

Detailed Description
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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.

Official Title
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Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions in Patients With Severe Aortic Stenosis or Mitral Regurgitation

Conditions
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Aortic Valve Stenosis, Mitral Regurgitation, Coronary Artery Disease, Fractional Flow Reserve

Intervention / Treatment
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* Diagnostic Test: Coronary Physiology assessment


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single-arm, observational study with invasive measurements in two cohorts (TAVI cohort and TMVr cohort).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>Coronary physiology measurements both pre- and post- transcatheter left-sided valvular intervention. | Diagnostic Test: Coronary Physiology assessment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Physiology