Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions

Coronary Artery Disease Clinical Trial

— POTUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05374733
• Other study ID #: POTUS
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: May 2022
• Source: Erasmus Medical Center
• Contact: Nicolas M van Mieghem, MD, PhD
• Phone: +31 (0)10 70 352 60
• Email: n.vanmieghem[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Coronary Artery Disease
• Fractional Flow Reserve
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Diagnostic Test:
• Coronary Physiology assessment
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.

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.	Baseline
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)