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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelios Health Institute GmbH

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Patients whose CT-angiography was determined to be non-diagnostic/unreadable during its evaluation

Previous coronary artery bypass grafting with patent grafts to the interrogated vessel

Patients with severe lesions with a diameter stenosis ≥ 90%, flow-limiting lesions, or a significant left main coronary artery stenosis

Critical coronary artery disease deemed by the Heart Team to require immediate revascularization

Trial design

Treatments tested in this trial

  • Assession of complete coronary physiology

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Helios Health Institute GmbH

Lead sponsor

Heart Center Leipzig - University Hospital

Collaborator