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

Overview

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, we aim to correlate invasive functional testing (FFR and RFR) with non-invasive CT-FFR before and 6 months after TAVI.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2022

Detailed Description

Prospective, single center, open-label study to 1. compare coronary flow reserve (CFR), index of microvascular resistance (IMR), fractional flow reserve (FFR) and resting full cycle ratio (RFR) values before TAVI and 6 months after TAVI 2. correlate testing of microcirculatory function (IMR) with measurements of functional testing (FFR and RFR) before and six months after TAVI 3. correlate functional testing (FFR and RFR) with computed tomography (CT) derived fractional flow reserve (CT-FFR) before and six months after TAVI.

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.

Arms, Groups and Cohorts

  • Other: Coronary physiology
    • Assession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI.

Clinical Trial Outcome Measures

Primary Measures

  • Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI
    • Time Frame: 6 Months

Secondary Measures

  • Diagnostic accuracy by considering FFR values of >0.80 as normal
    • Time Frame: 6 Months
    • diagnostic accuracy (sensitivity, specificity, positive predictive value [PPV] and negative predictive value [NPV]) of CT-FFR for the detection of significant coronary stenosis before and 6 months after TAVI by considering FFR values of >0.80 as normal
  • Diagnostic accuracy by considering RFR values of >0.89 as normal
    • Time Frame: 6 Months
    • diagnostic accuracy (sensitivity, specificity, positive predictive value [PPV] and negative predictive value [NPV]) of CT-FFR for the detection of significant coronary stenosis before and 6 months after TAVI by considering RFR values of >0.89 as normal

Participating in This Clinical Trial

Inclusion Criteria

  • 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) Exclusion Criteria:

  • 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 – Contraindication to adenosine (e.g. bronchial asthma) – Chronic renal impairment with severe reduction of glomerular filtration rate (eGFR <30 ml/min) – Presence of cardiogenic shock – Participation in another interventional study involving the left heart or coronary arteries

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Leipzig Heart Institute GmbH
  • Collaborator
    • Heart Center Leipzig – University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nicolas Majunke, Dr., Study Chair, Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
    • Robin Gohmann, Dr., Principal Investigator, Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
    • Mohamed Abdel-Wahab, Prof. Dr., Principal Investigator, Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
  • Overall Contact(s)
    • Nicolas Majunke, Dr., +49 341 865 1428, nicolas.majunke@medizin.uni-leipzig.de

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