Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions (POTUS)

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

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Aortic Valve Stenosis; Mitral Regurgitation; Fractional Flow Reserve
• Intervention / Treatment: Diagnostic test: Coronary Physiology assessment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas M van Mieghem, MD, PhD; Phone Number: +31 (0)10 70 352 60; Email: n.vanmieghem@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015GD
    • Recruiting
    • Erasmus MC
    • Contact: Nicolas M van Mieghem, MD, PhD; Phone Number: +31(0)107035260; Email: n.vanmieghem@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm; Coronary physiology measurements both pre- and post- transcatheter left-sided valvular 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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Nicolas M van Mieghem, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Coronary Physiology
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Coronary Artery Disease; Aortic Valve Stenosis; Mitral Valve Insufficiency; Constriction, Pathologic
• Other Study ID Numbers: POTUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes