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

Coronary Artery Stenosis Clinical Trial

— CHOICE-FR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133843
• Other study ID #: 2021-0125
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Coronary Artery Stenosis
• Coronary Stenosis
• Transcatheter Aortic Valve Implantation

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