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Impact of pulsatile bidirectional cavopulmonary connection on post-Fontan flow dynamics and endothelial function in single ventricle physiology: a prospective study

Impact of pulsatile bidirectional cavopulmonary connection on post-Fontan flow dynamics and endothelial function in single ventricle physiology: a prospective study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20250924010
Enrollment
62
Registered
2025-09-24
Start date
2026-04-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Change in thrombomodulin, vWF Ag and CBA in patients who underwent classical Glenn and pulsatile Glenn operation that completed Fontan operation. Pulsatile Glenn, Antegrade pulmonary blood flow, thrombomodulin, endothelial dysfunction, Von Willebrand factor

Interventions

Patients who underwent pulsatile Glenn operation and complete Fontan operation,Patients who underwent classical Glenn operation and complete Fontan operation
Other,Other

Sponsors

Siriraj hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. All consecutive post-Fontan patients age 1 to 60 years old who previously underwent pulsatile bidirectional cavopulmonary connection at Siriraj hospital and aged match post-Fontan patients who did not.

Exclusion criteria

Exclusion criteria: 1. Patients who were not undergone true bidirectional cavopulmonary connection such as Kawashima operation and one-and-a-half operation. 2. Patients whose laboratory data related with endothelial dysfunction and 4D-flow CMR were incomplete. 3. Patients who are known to have disease that associated with abnormal bleeding tendency or thrombosis.

Design outcomes

Primary

MeasureTime frame
Endothelial dysfunction post-Fontan operation thrombomodulin, vWF: Ag, vWF: CBA

Secondary

MeasureTime frame
Flow mechanics on 4D flow CMR post-Fontan operation Cardiac MRI parameters

Countries

Thailand

Contacts

Public ContactChodchanok Vijarnsorn

Faculty of Medicine Siriraj Hospital

cvijarnsorn@yahoo.com0813447015

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026