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NCT Number: NCT05133843

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Leipzig, 04289, Germany

Location status: Recruiting

Location contact

Mohamed Abdel-Wahab, Prof. Dr.

CONTACT

Mohamed Abdel-Wahab, Prof. Dr.

PRINCIPAL_INVESTIGATOR

Nicolas Majunke, Dr.

CONTACT

[email protected]

+49 341 865 1428

Nicolas Majunke, Dr.

PRINCIPAL_INVESTIGATOR

Robin Gohmann, Dr.

PRINCIPAL_INVESTIGATOR

About this study

Prospective, single center, open-label study to

  • 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
  • correlate testing of microcirculatory function (IMR) with measurements of functional testing (FFR and RFR) before and six months after TAVI
  • correlate functional testing (FFR and RFR) with computed tomography (CT) derived fractional flow reserve (CT-FFR) before and six months after TAVI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assession of complete coronary physiology

Procedure

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

Other names: FFR, RFR, CFR, IMR, and CT-FFR

Primary outcomes

  1. Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI

    Time frame: 6 Months

    Comparison of coronary flow reserve, index of microvascular resistance, fractional flow reserve and resting full cycle ratio.

    The variation in correlation between CT-FFR and IMR, FFR or RFR before and after TAVI will be estimated using a General Linear Model (GLM) with an interaction between the independent variable (IMR, FFR, RFR) and the time period (before or after TAVI).

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Abdel-Wahab, Prof. Dr.

CONTACT

Nicolas Majunke, Dr.

CONTACT

[email protected]

+49 341 865 1428

Sponsors and collaborators

Lead sponsor

Helios Health Institute GmbH

Other

Collaborators

  • Heart Center Leipzig - University Hospital

Registry information

Acronym: CHOICE-FR

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Nov 24, 2021
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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