Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions

NCT05374733 | Unknown FDA Device

• 1 other identifier: POTUS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aortic Valve Stenosis; Mitral Regurgitation; Coronary Artery Disease; Fractional Flow Reserve

Keywords

Coronary Physiology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• The change in RFR before and after transcatheter valvular intervention (either TAVI or TMVr)

  Directly before and after the TAVI/TMVr procedure (1 hour)

• The change in dPR before and after transcatheter valvular intervention (either TAVI or TMVr)

  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)

  Directly before and after the TAVI/TMVr procedure (1 hour)

• The change in CFR before and after transcatheter valvular intervention (either TAVI or TMVr)

  Directly before and after the TAVI/TMVr procedure (1 hour)

• The change in IMR before and after transcatheter valvular intervention (either TAVI or TMVr)

  Directly before and after the TAVI/TMVr procedure (1 hour)

Other Outcomes (7)

• The difference in the mean change in the FFR between the TAVI cohort and the TMVR cohort.

  Baseline

• The difference in the mean change in the RFR between the TAVI cohort and the TMVR cohort.

  Baseline

• The difference in the mean change in the dPR between the TAVI cohort and the TMVR cohort.

  Baseline

Study Arms (1)

Single arm

OTHER

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

Diagnostic Test: Coronary Physiology assessment

Interventions

Coronary Physiology assessment DIAGNOSTIC_TEST

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.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, 3015GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Mitral Valve Insufficiency; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Nicolas M van Mieghem, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas M van Mieghem, MD, PhD

CONTACT

+31 (0)10 70 352 60; n.vanmieghem@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Nicolas M. Van Mieghem

Model Details: Prospective, single-arm, observational study with invasive measurements in two cohorts (TAVI cohort and TMVr cohort).

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: May 16, 2022
• Study Start: March 22, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)