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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Stenosis; Transcatheter Aortic Valve Implantation
• Intervention / Treatment: Procedure: Assession of complete coronary physiology

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Majunke, Dr.; Phone Number: +49 341 865 1428; Email: nicolas.majunke@medizin.uni-leipzig.de
• Study Contact Backup: Name: Mohamed Abdel-Wahab, Prof. Dr.

Study Locations

• Germany
  • Leipzig, Germany, 04289
    • Recruiting
    • Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology
    • Contact: Nicolas Majunke, Dr.; Phone Number: +49 341 865 1428; Email: nicolas.majunke@medizin.uni-leipzig.de
    • Contact: Mohamed Abdel-Wahab, Prof. Dr.
    • Principal Investigator: Nicolas Majunke, Dr.
    • Principal Investigator: Robin Gohmann, Dr.
    • Principal Investigator: Mohamed Abdel-Wahab, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Coronary physiology; Assession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI.	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.; Other Names: FFR, RFR, CFR, IMR, and CT-FFR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Helios Health Institute GmbH
• Collaborators: Heart Center Leipzig - University Hospital
• Investigators: Study Chair: Nicolas Majunke, Dr., Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology; Principal Investigator: Robin Gohmann, Dr., Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology; Principal Investigator: Mohamed Abdel-Wahab, Prof. Dr., Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: coronary microcirculatory function; transcatheter aortic valve implantation; Coronary Artery Stenosis; fractional flow reserve; coronary physiology; coronary blood flow; non-invasive CT-FFR; resting full cycle ratio
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Aortic Valve Stenosis; Constriction, Pathologic; Coronary Stenosis
• Other Study ID Numbers: 2021-0125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No