Coronary Physiology Peri-Transcatheter Left-sided Valvular Interventions
NCT05374733 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2022-05-16
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
Interventions
- 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.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Nicolas M van Mieghem, MD, PhD · Erasmus Medical Center
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-22
- Primary Completion
- 2023-03-01
- Completion
- 2023-03-01
- FDA Device
- Yes
Countries
- Netherlands
Study Locations
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