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RecruitingNCT05133843CHOICE-FRUpdated Nov 25, 2024

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

An interventional study of Assession of complete coronary physiology in Coronary Artery Stenosis and Transcatheter Aortic Valve Implantation, sponsored by Helios Health Institute GmbH. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-25.

Sponsored by Helios Health Institute GmbH · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Sep 2021; still recruiting 5 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • 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
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's planned enrollment of 50 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Helios Health Institute GmbH is the lead sponsor of 17 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureAssession of complete coronary physiology

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

    Also known as: FFR, RFR, CFR, IMR, and CT-FFR

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 Months

Secondary outcomes

  1. 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

    Time frame: 6 Months

  2. 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

    Time frame: 6 Months

07

Study locations

1 of 1 sites recruiting
  • Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology
    Leipzig, 04289, Germany
    • Nicolas Majunke, Dr. · Contact · nicolas.majunke@medizin.uni-leipzig.de · +49 341 865 1428
    • Mohamed Abdel-Wahab, Prof. Dr. · Contact
    • Nicolas Majunke, Dr. · Principal investigator
    • Robin Gohmann, Dr. · Principal investigator
    • Mohamed Abdel-Wahab, Prof. Dr. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05133843
Lead sponsor
Helios Health Institute GmbH
Collaborators
Heart Center Leipzig - University Hospital
Responsible party
Sponsor
First posted
Nov 24, 2021
Start date
Sep 29, 2021
Primary completion
Sep 30, 2024
Completion
Sep 30, 2025 (estimated)
Last update
Nov 25, 2024

Study contacts

Nicolas Majunke, Dr.
Contact
nicolas.majunke@medizin.uni-leipzig.de
+49 341 865 1428
Mohamed Abdel-Wahab, Prof. Dr.
Contact
Nicolas Majunke, Dr.
study chair · Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Robin Gohmann, Dr.
principal investigator · Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Mohamed Abdel-Wahab, Prof. Dr.
principal investigator · Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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