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Recruiting 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

No phase Interventional Coronary Artery Stenosis Transcatheter Aortic Valve Implantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assession of complete coronary physiology.
Who it may be relevant to
Registry conditions: Coronary Artery Stenosis, Transcatheter Aortic Valve Implantation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

Primary outcome measures

  • Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI [Time frame: 6 Months]
Secondary outcome measures (2)
  • Diagnostic accuracy by considering FFR values of >0.80 as normal [Time frame: 6 Months]
  • Diagnostic accuracy by considering RFR values of >0.89 as normal [Time frame: 6 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Germany · 1 center
  • Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology — Leipzig

Identifiers

NCT: NCT05133843 · 2021-0125

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗