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

Primary Purpose

Aortic Valve Stenosis, Mitral Regurgitation, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Coronary Physiology assessment
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Valve Stenosis focused on measuring Coronary Physiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Erasmus MCRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

Coronary physiology measurements both pre- and post- transcatheter left-sided valvular intervention.

Outcomes

Primary Outcome Measures

The change in the FFR value before and after TAVI
The impact of TAVI on FFR
The change in the FFR value before and after TMVr
The impact of TMVr on FFR

Secondary Outcome Measures

The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on RFR
The change in dPR before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on dPR
The change in Pd/Pa before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on Pd/Pa
The change in CFR before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on CFR
The change in IMR before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on IMR
The change in transvalvular gradient before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on the transvalvular gradient
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
The change in systemic aortic pressure before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on hemodynamics
The change in heart rate before and after transcatheter valvular intervention (either TAVI or TMVr)
The impact of TAVI/TMVr on hemodynamics

Full Information

First Posted
September 21, 2021
Last Updated
May 13, 2022
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05374733
Brief Title
Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions
Acronym
POTUS
Official Title
Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions in Patients With Severe Aortic Stenosis or Mitral Regurgitation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Mitral Regurgitation, Coronary Artery Disease, Fractional Flow Reserve
Keywords
Coronary Physiology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single-arm, observational study with invasive measurements in two cohorts (TAVI cohort and TMVr cohort).
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Other
Arm Description
Coronary physiology measurements both pre- and post- transcatheter left-sided valvular intervention.
Intervention Type
Diagnostic Test
Intervention Name(s)
Coronary Physiology assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in the FFR value before and after TAVI
Description
The impact of TAVI on FFR
Time Frame
Directly before and after the TAVI procedure (1 hour)
Title
The change in the FFR value before and after TMVr
Description
The impact of TMVr on FFR
Time Frame
Directly before and after the TMVr procedure (1 hour)
Secondary Outcome Measure Information:
Title
The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr)
Description
The impact of TAVI/TMVr on RFR
Time Frame
Directly before and after the TAVI/TMVr procedure (1 hour)
Title
The change in dPR before and after transcatheter valvular intervention (either TAVI or TMVr)
Description
The impact of TAVI/TMVr on dPR
Time Frame
Directly before and after the TAVI/TMVr procedure (1 hour)
Title
The change in Pd/Pa before and after transcatheter valvular intervention (either TAVI or TMVr)
Description
The impact of TAVI/TMVr on Pd/Pa
Time Frame
Directly before and after the TAVI/TMVr procedure (1 hour)
Title
The change in CFR before and after transcatheter valvular intervention (either TAVI or TMVr)
Description
The impact of TAVI/TMVr on CFR
Time Frame
Directly before and after the TAVI/TMVr procedure (1 hour)
Title
The change in IMR before and after transcatheter valvular intervention (either TAVI or TMVr)
Description
The impact of TAVI/TMVr on IMR
Time Frame
Directly before and after the TAVI/TMVr procedure (1 hour)
Title
The change in transvalvular gradient before and after transcatheter valvular intervention (either TAVI or TMVr)
Description
The impact of TAVI/TMVr on the transvalvular gradient
Time Frame
Directly before and after the TAVI/TMVr procedure (1 hour)
Title
The change in left ventricular end-diastolic pressure (LVEDP) before and after transcatheter valvular intervention (either TAVI or TMVr)
Description
The impact of TAVI/TMVr on the LVEDP
Time Frame
Directly before and after the TAVI/TMVr procedure (1 hour)
Title
The change in systemic aortic pressure before and after transcatheter valvular intervention (either TAVI or TMVr)
Description
The impact of TAVI/TMVr on hemodynamics
Time Frame
Directly before and after the TAVI/TMVr procedure (1 hour)
Title
The change in heart rate before and after transcatheter valvular intervention (either TAVI or TMVr)
Description
The impact of TAVI/TMVr on hemodynamics
Time Frame
Directly before and after the TAVI/TMVr procedure (1 hour)
Other Pre-specified Outcome Measures:
Title
The difference in the mean change in the FFR between the TAVI cohort and the TMVR cohort.
Description
The mean change in the FFR in TAVI patients will be compared to mean change in FFR in TMVr patients.
Time Frame
Baseline
Title
The difference in the mean change in the RFR between the TAVI cohort and the TMVR cohort.
Description
The mean change in the RFR in TAVI patients will be compared to mean change in RFR in TMVr patients.
Time Frame
Baseline
Title
The difference in the mean change in the dPR between the TAVI cohort and the TMVR cohort.
Description
The mean change in the dPR in TAVI patients will be compared to mean change in dPR in TMVr patients.
Time Frame
Baseline
Title
The difference in the mean change in the Pd/Pa between the TAVI cohort and the TMVR cohort.
Description
The mean change in the Pd/Pa in TAVI patients will be compared to mean change in Pd/Pa in TMVr patients.
Time Frame
Baseline
Title
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.
Description
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.
Time Frame
Baseline
Title
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.
Description
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%.
Time Frame
Baseline
Title
The diagnostic performance of vessel FFR (vFFR; an angiography-based FFR index) in the setting of valvular heart disease.
Description
The vFFR pre-intervention will be validated against the FFR-value both pre- and post-intervention
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas M van Mieghem, MD, PhD
Phone
+31 (0)10 70 352 60
Email
n.vanmieghem@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas M van Mieghem, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas M van Mieghem, MD, PhD
Phone
+31(0)107035260
Email
n.vanmieghem@erasmusmc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions

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