Back to results

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)

Primary Purpose

Coronary Artery Stenosis, Transcatheter Aortic Valve Implantation

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Assession of complete coronary physiology

About this trial

This is an interventional diagnostic trial for Coronary Artery Stenosis focused on measuring Coronary Artery Stenosis, transcatheter aortic valve implantation, coronary physiology, coronary blood flow, coronary microcirculatory function, non-invasive CT-FFR, fractional flow reserve, resting full cycle ratio

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Coronary physiology

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Diagnostic accuracy by considering RFR values of >0.89 as normal

Full Information

NCT ID

NCT05133843

First Posted

November 12, 2021

Last Updated

September 28, 2023

Sponsor

Helios Health Institute GmbH

Collaborators

Heart Center Leipzig - University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05133843

Brief 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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 29, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Helios Health Institute GmbH

Collaborators

Heart Center Leipzig - University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Stenosis, Transcatheter Aortic Valve Implantation

Keywords

Coronary Artery Stenosis, transcatheter aortic valve implantation, coronary physiology, coronary blood flow, coronary microcirculatory function, non-invasive CT-FFR, fractional flow reserve, resting full cycle ratio

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, single center, open-label

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Coronary physiology

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Assession of complete coronary physiology

Other Intervention Name(s)

FFR, RFR, CFR, IMR, and CT-FFR

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

6 Months

Secondary Outcome Measure Information:

Title

Diagnostic accuracy by considering FFR values of >0.80 as normal

Description

Time Frame

6 Months

Title

Diagnostic accuracy by considering RFR values of >0.89 as normal

Description

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicolas Majunke, Dr.

Phone

+49 341 865 1428

nicolas.majunke@medizin.uni-leipzig.de

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Abdel-Wahab, Prof. Dr.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Majunke, Dr.

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Robin Gohmann, Dr.

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohamed Abdel-Wahab, Prof. Dr.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Leipzig

ZIP/Postal Code

04289

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas Majunke, Dr.

Phone

+49 341 865 1428

nicolas.majunke@medizin.uni-leipzig.de

First Name & Middle Initial & Last Name & Degree

Mohamed Abdel-Wahab, Prof. Dr.

First Name & Middle Initial & Last Name & Degree

Nicolas Majunke, Dr.

First Name & Middle Initial & Last Name & Degree

Robin Gohmann, Dr.

First Name & Middle Initial & Last Name & Degree

Mohamed Abdel-Wahab, Prof. Dr.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs