Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD

NCT06282926 | Active Not Recruiting FDA Device

• 1 other identifier: 324811
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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.

  To study what is the maximum considered acceptable mean difference between RV volumes measures between CMR and TTE-3DKBR.

  First year of the study

• Evaluate the effects of chronic RV volume overload in this population within one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurement of GLS.

  To study the predictive value of RV volumes using TTE-3DKBR to assess RV systolic dysfunction defined by GLS below -18%.

  Second year of the study

Secondary Outcomes (1)

• Compare TTE-3DKBR evaluation to the conventional 2D echocardiography measurements used in routine clinical practice (TAPSE, TDI, FAC, and GLS).

  First year of the study

Study Arms (2)

Group 1

Healthy adult volunteers

Diagnostic Test: Echocardiography assessment

Group 2

ACHD patients with repaired Tetralogy of Fallot and known moderate or severe pulmonary regurgitation

Diagnostic Test: Echocardiography assessment

Interventions

Echocardiography assessment DIAGNOSTIC_TEST

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.

Also known as: Cardiac Magnetic Resonance

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Group 1 of healthy adult volunteers Group 2 of ACHD patients with repaired Tetralogy of Fallot and known moderate or severe pulmonary regurgitation

You may qualify if:

• Group 1 of healthy adult volunteers - Minimum aged of 18 years old without evidence of structural heart disease.
• Group 2 of ACHD patients - ACHD patient minimum aged of 18 years old with diagnosis of moderate or severe pulmonary regurgitation after ToF repair.

You may not qualify if:

• Group 1 of healthy adult volunteers - No informed consent, evidence of structural heart disease.
• Group 2 of ACHD patients - No informed consent, pacemaker or defibrillator non-compatible with CMR, limited echocardiographic images for image acquisition, and evidence of moderate or severe right ventricle inflow and/or right ventricle outflow tract obstruction.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Manchester Metropolitan University: collaborator

Study Sites (1)

Guys and St Thomas

London, United Kingdom

Location

MeSH Terms

Conditions

Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dario Luis Leal de Freitas, BSc

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: February 28, 2024
• Study Start: April 11, 2024
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

GB (1)