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Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.

NCT05708118 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2023-02-01

No results posted yet for this study

Summary

The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients who underwent elective aortic valve replacement or TAVR for stenotic bicuspid aortic valve (BAV) at our institution from 2015 to June 2022.

Participants will undergo both a CT and an echocardiographic assessment at least 90 days after surgery.

Conditions

  • Bicuspid Aortic Valve
  • Aortic Valve Stenosis
  • Aortic Aneurysm
  • Heart Diseases
  • Valvular Heart Disease
  • Valvular Aortic Stenosis
  • Ascending Aorta Aneurysm

Interventions

DIAGNOSTIC_TEST

Echocardiographic assessment.

Patients will be contacted to carry out an echocardiography at least 90 days after surgery. Measurements will be taken for aortic annulus, sinuses of Valsalva, sino-tubular junction, tubular ascending aorta. Aortic valve will be assessed as well.

DIAGNOSTIC_TEST

Computed-tomography assessment

All enrolled patients will undergo a multislice CT scan (retrospectively ECG-gated, whenever possible) with standard contrast medium injection protocol of nonionic contrast agent. All post-surgery controls will be performed at least 90 days after surgery. All CT datasets will be analysed on a dedicated workstation for the qualitative and quantitative assessment of the aortic root including measurements for aortic annulus, sinuses of Valsalva, sino-tubular junction, tubular ascending aorta.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Giovanni A Chiariello, MD · Policlinico Agostino Gemelli

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2024-01-21
Completion
2024-01-21

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05708118 on ClinicalTrials.gov