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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05133843
Other study ID # 2021-0125
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 29, 2021
Est. completion date June 30, 2024

Study information

Verified date September 2023
Source Helios Health Institute GmbH
Contact Nicolas Majunke, Dr.
Phone +49 341 865 1428
Email nicolas.majunke@medizin.uni-leipzig.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology Leipzig

Sponsors (2)

Lead Sponsor Collaborator
Helios Health Institute GmbH Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI 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).
6 Months
Secondary Diagnostic accuracy by considering FFR values of >0.80 as normal 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 6 Months
Secondary Diagnostic accuracy by considering RFR values of >0.89 as normal 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 6 Months
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