MedTrace Logo

Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD

NCT06282926 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 59

Last updated 2025-07-25

No results posted yet for this study

Summary

The main objective of this study is to evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair.

As part of the validation study, the reproducibility of the TTE-3DKBR in assessing RV volume and EF will also be tested in a group of healthy adult volunteers. Additionally, TTE-3DKBR evaluation will be compared in both groups to the conventional 2D echocardiography measurements used in routine clinical practice, such as tricuspid annular plane systolic excursion (TAPSE), tissue Doppler imaging (TDI), fractional area change (FAC), and global longitudinal strain (GLS).

Another objective of the study is also to evaluate the effects of chronic RV volume overload with an interval of one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurements, particularly with GLS.

The study will end when the required number of patients have been enrolled and when the last subject undergoes the research dataset acquisition. The study may be terminated prematurely if it becomes apparent that the recruitment target cannot be met within the projected recruitment phase.

Conditions

  • Tetralogy of Fallot

Interventions

DIAGNOSTIC_TEST

Echocardiography assessment

Group 1 will have healthy adult volunteers recruited at the workplace following specific criteria to participate in the study. A research cardiac ultrasound protocol to assess the RV will be performed at two different visits, with a maximum interval of two weeks between them. Group 2 will have ACHD patients with known moderate or severe pulmonary regurgitation after ToF repair, following specific criteria to participate in the study. This group of patients will be studied in two separate visits. The patients will be recruited during the first visit when attending to an existing hospital appointment for ACHD CMR. A research cardiac ultrasound protocol to assess the RV will be performed on the same day, either before or after the CMR. For all patients who will have a second follow-up visit at the ACHD outpatient clinic within a maximum interval of one year, the same research protocol will be performed, in addition to the usual cardiac ultrasound.

Sponsors & Collaborators

  • Manchester Metropolitan University

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Dario Luis Leal de Freitas, BSc · Guy's and St Thomas' NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-11
Primary Completion
2025-09-26
Completion
2025-09-26
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT06282926 on ClinicalTrials.gov