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 acronym: CHOICE-FR
StatusUnknown
PhaseNot applicable
Started

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Re-verified, no change to tracked fieldsv5
  3. Primary completion date: Dec 31, 2023 to Sep 30, 2024
    • Study completion date: Jun 30, 2024 to Sep 30, 2025
    v4
  4. Primary completion date: Sep 30, 2022 to Dec 31, 2023
    • Study completion date: Mar 31, 2023 to Jun 30, 2024
    v3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05133843
Lead Sponsor Helios Health Institute GmbH
Collaborators: Heart Center Leipzig - University Hospital
Conditions
(from sponsor)		 Coronary Artery Stenosis, Transcatheter Aortic Valve Implantation
Related terms Coronary Stenosis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov