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

Last updated: November 22, 2024
Sponsor: Helios Health Institute GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Treatment

Assession of complete coronary physiology

Clinical Study ID

NCT05133843
2021-0125
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18 years

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

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

  • Patients who have undergone coronary CT angiography before TAVI in which CAD couldnot be ruled out

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

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

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

Exclusion

Exclusion Criteria:

  • Patients whose CT-angiography was determined to be non-diagnostic/unreadable duringits evaluation

  • Previous coronary artery bypass grafting with patent grafts to the interrogatedvessel

  • 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 immediaterevascularization

  • 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 coronaryarteries

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Assession of complete coronary physiology
Phase:
Study Start date:
September 29, 2021
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology

    Leipzig, 04289
    Germany

    Active - Recruiting

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