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NCT07016477 · ClinicalTrials.gov registry record

Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure

A clinical trial of Coronary Artery Disease and Aortic Valve Stenosis, sponsored by Semmelweis University.

Recruiting
Registry status
1,000
Enrollment target
7
Study locations

NCT07016477: Recruiting study of Coronary Artery Disease and Aortic Valve Stenosis, sponsored by Semmelweis University.

NCT07016477 is a study of Coronary Artery Disease and Aortic Valve Stenosis that is actively recruiting participants, run by Semmelweis University. The registered enrollment target is 1,000 participants, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (22% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07016477, a study of Coronary Artery Disease and Aortic Valve Stenosis, is actively recruiting participants, sponsored by Semmelweis University.

RECRUITING
Registry status
1,000 participants
Enrollment target
7
Study locations

Study Summary

The clinical and demographic characteristics of patients undergoing transcatheter aortic valve implantation (TAVI) pose unique challenges for coronary computed tomography (CT) imaging, as this patient population is mainly composed of elderly, frail individuals with severe aortic stenosis, multiple comorbidities, high prevalence of heavily calcified coronary artery disease (CAD) and revascularized coronary arteries. Such vulnerable patients could benefit from a more precise assessment and characterization of their CAD with ultra-high resolution (UHR) photon-counting detector (PCD) CT that would potentially avoid the need for pre-implantation invasive coronary angiography (ICA). This international multicenter prospective registry study aims to investigate the feasibility and diagnostic accuracy of PCD-CT in the assessment of CAD in the high-risk population of patients undergoing TAVI, as compared to ICA.

Primary Outcome

Assessment of the diagnostic accuracy (sensitivity, specificity, PPV, NPV) of UHR PCD-CT coronary angiography as compared to invasive coronary angiography (ICA) within three months of PCD-CT

Conditions Studied

Coronary Artery Disease Aortic Valve Stenosis Tomography, X-Ray Computed

Interventions

  • DIAGNOSTIC_TEST Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography

Study Locations (7)

Other

  • Albert-Ludwigs-Universität Freiburg - Freiburg im Breisgau
  • University Medical Center Mainz - Mainz
  • Universitätsklinikum Tübingen - Tübingen
  • Semmelweis University - Budapest
  • Maastricht University - Maastricht
  • University Hospital of Zürich - Zurich

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2024-06-01
Est. Completion 2030-05-30
Semmelweis University

1 total trials

What NCT07016477 shows while recruiting

NCT07016477 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, below the 1,282-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (22% lower).

The record links to 3 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography is the first listed.

NCT07016477 lists 7 locations in 2 states (Other, South Carolina).

Frequently Asked Questions

What is clinical trial NCT07016477 about?

NCT07016477 is a clinical study titled "Prospective Registry of Patients Undergoing Cardiac CT With NAEOTOM Alpha PCD-CT Before TAVI Procedure". The clinical and demographic characteristics of patients undergoing transcatheter aortic valve implantation (TAVI) pose unique challenges for coronary computed tomography (CT) imaging, as this patient population is mainly composed of elderly, frail individuals with severe aortic stenosis, multiple c...

What is the current status of trial NCT07016477?

This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2024-06-01. Estimated completion is 2030-05-30.

What conditions does trial NCT07016477 study?

This clinical trial studies the following conditions: Coronary Artery Disease, Aortic Valve Stenosis, Tomography, X-Ray Computed.

What interventions are being tested in trial NCT07016477?

The interventions under investigation include: Ultra-High Resolution Photon Counting Detector Coronary Computed Tomography Angiography (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT07016477?

This trial is sponsored by Semmelweis University, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07016477 being conducted?

This trial has 7 study locations across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Coronary Artery Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07016477's enrollment target sits among peer trials

1,000 46th of 219 higher than 171 of 219 other Coronary Artery Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07016477

Source: ClinicalTrials.gov NCT07016477, the US trial registry maintained by the National Library of Medicine. NCT07016477 (large enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.