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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05133843 on ClinicalTrials.gov