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

May 13, 2022 updated by: Nicolas van Mieghem, Erasmus Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single arm
Coronary physiology measurements both pre- and post- transcatheter left-sided valvular intervention.
Diagnostic test: Coronary Physiology assessment
  1. 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.
  2. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change in the FFR value before and after TAVI
Time Frame: Directly before and after the TAVI procedure (1 hour)
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
Time Frame: Directly before and after the TMVr procedure (1 hour)
The impact of TMVr on FFR
Directly before and after the TMVr procedure (1 hour)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr)
Time Frame: Directly before and after the TAVI/TMVr procedure (1 hour)
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)
Time Frame: Directly before and after the TAVI/TMVr procedure (1 hour)
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)
Time Frame: Directly before and after the TAVI/TMVr procedure (1 hour)
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)
Time Frame: Directly before and after the TAVI/TMVr procedure (1 hour)
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)
Time Frame: Directly before and after the TAVI/TMVr procedure (1 hour)
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)
Time Frame: Directly before and after the TAVI/TMVr procedure (1 hour)
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)
Time Frame: Directly before and after the TAVI/TMVr procedure (1 hour)
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)
Time Frame: Directly before and after the TAVI/TMVr procedure (1 hour)
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)
Time Frame: Directly before and after the TAVI/TMVr procedure (1 hour)
The impact of TAVI/TMVr on hemodynamics
Directly before and after the TAVI/TMVr procedure (1 hour)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The difference in the mean change in the FFR between the TAVI cohort and the TMVR cohort.
Time Frame: Baseline
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.
Time Frame: Baseline
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.
Time Frame: Baseline
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.
Time Frame: Baseline
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.
Time Frame: Baseline
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.
Time Frame: Baseline
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.
Time Frame: Baseline
The vFFR pre-intervention will be validated against the FFR-value both pre- and post-intervention
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolas M van Mieghem, MD, PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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