Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years

• Willing to participate and able to understand, read and sign the informed consent document before the planned procedure

• Severe symptomatic aortic stenosis with indication for TAVI according to current guidelines deemed by the Heart Team

• Patients who have undergone coronary CT angiography before TAVI in which CAD could not be ruled out

• CAD in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed coronary stenosis, in which the physiological severity of the lesion is in question (typically 40-90% diameter stenosis).

• Eligible for invasive coronary angiography and functional assessment (FFR, RFR, CFR and IMR)

• Eligible for coronary CT-angiography and functional assessment (CT-FFR)

Locations
Other Locations
Germany
Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology
RECRUITING
Leipzig
Contact Information
Primary
Nicolas Majunke, Dr.
nicolas.majunke@medizin.uni-leipzig.de
+49 341 865 1428
Backup
Mohamed Abdel-Wahab, Prof. Dr.
Time Frame
Start Date: 2021-09-29
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 50
Treatments
Other: 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
Leads: Helios Health Institute GmbH

This content was sourced from clinicaltrials.gov