Clinical trial NCT05374733: Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions
Official title: Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions in Patients With Severe Aortic Stenosis or Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenosis
Mitral Regurgitation
Coronary Artery Disease
Fractional Flow Reserve
Keywords: Coronary Physiology
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-arm, observational study with invasive measurements in two cohorts (TAVI cohort and TMVr cohort).
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change in the FFR value before and after TAVI
timeFrame: Directly before and after the TAVI procedure (1 hour)
measure: The change in the FFR value before and after TMVr
timeFrame: Directly before and after the TMVr procedure (1 hour)
Secondary outcomes:
measure: The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr)
timeFrame: Directly before and after the TAVI/TMVr procedure (1 hour)
measure: The change in dPR before and after transcatheter valvular intervention (either TAVI or TMVr)
timeFrame: Directly before and after the TAVI/TMVr procedure (1 hour)
measure: The change in Pd/Pa before and after transcatheter valvular intervention (either TAVI or TMVr)
timeFrame: Directly before and after the TAVI/TMVr procedure (1 hour)
measure: The change in CFR before and after transcatheter valvular intervention (either TAVI or TMVr)
timeFrame: Directly before and after the TAVI/TMVr procedure (1 hour)
measure: The change in IMR before and after transcatheter valvular intervention (either TAVI or TMVr)
timeFrame: Directly before and after the TAVI/TMVr procedure (1 hour)
measure: The change in transvalvular gradient before and after transcatheter valvular intervention (either TAVI or TMVr)
timeFrame: Directly before and after the TAVI/TMVr procedure (1 hour)
measure: The change in left ventricular end-diastolic pressure (LVEDP) before and after transcatheter valvular intervention (either TAVI or TMVr)
timeFrame: Directly before and after the TAVI/TMVr procedure (1 hour)
measure: The change in systemic aortic pressure before and after transcatheter valvular intervention (either TAVI or TMVr)
timeFrame: Directly before and after the TAVI/TMVr procedure (1 hour)
measure: The change in heart rate before and after transcatheter valvular intervention (either TAVI or TMVr)
timeFrame: Directly before and after the TAVI/TMVr procedure (1 hour)
Other outcomes:
measure: The difference in the mean change in the FFR between the TAVI cohort and the TMVR cohort.
timeFrame: Baseline
measure: The difference in the mean change in the RFR between the TAVI cohort and the TMVR cohort.
timeFrame: Baseline
measure: The difference in the mean change in the dPR between the TAVI cohort and the TMVR cohort.
timeFrame: Baseline
measure: The difference in the mean change in the Pd/Pa between the TAVI cohort and the TMVR cohort.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: The diagnostic performance of vessel FFR (vFFR; an angiography-based FFR index) in the setting of valvular heart disease.
timeFrame: Baseline
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Nicolas M van Mieghem, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: