Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
NCT05133843 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-11-25
Summary
The purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. This aims to determine how TAVI affects coronary blood flow and coronary microcirculatory function after longer-term follow-up, and how these effects influence FFR and RFR values. In addition, it is aimed to correlate invasive functional testing (FFR and RFR) with non-invasive CT-FFR before and 6 months after TAVI.
Conditions
- Coronary Artery Stenosis
- Transcatheter Aortic Valve Implantation
Interventions
- PROCEDURE
-
Assession of complete coronary physiology
Assession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI.
Sponsors & Collaborators
-
Heart Center Leipzig - University Hospital
collaborator OTHER -
Helios Health Institute GmbH
lead OTHER
Principal Investigators
-
Nicolas Majunke, Dr. · Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
-
Robin Gohmann, Dr. · Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
-
Mohamed Abdel-Wahab, Prof. Dr. · Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-29
- Primary Completion
- 2024-09-30
- Completion
- 2025-09-30
Countries
- Germany
Study Locations
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