Health TrialsbyHealthPanel

RVOT Stenting Versus Surgical RV-PA Conduit in Cyanotic Adults

ConditionsCyanotic Congenital Heart DiseaseRight Ventricular Outflow Tract Obstruction
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorAssiut University

About this trial

This prospective observational cohort study aims to compare clinical and hemodynamic outcomes of percutaneous right ventricular outflow tract stenting versus surgical right ventricle-to-pulmonary artery conduit placement in cyanotic adults with congenital heart disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- Age 16 years or older

Cyanotic congenital heart disease with significant right ventricular outflow tract obstruction requiring intervention

Undergoing either percutaneous RVOT stenting or surgical right ventricle-to-pulmonary artery conduit placement

Available baseline clinical, echocardiographic, and cardiac CT data

Disqualifiers

- Concomitant major cardiac surgery other than RV-PA conduit placement

Contraindications to contrast-enhanced cardiac CT

Inadequate CT image quality

Incomplete clinical or imaging data

Trial population

Adult patients aged 16 years or older with cyanotic congenital heart disease and significant right ventricular outflow tract obstruction undergoing either percutaneous RVOT stenting or surgical RV-PA conduit placement at Aswan Heart Center.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 2 trial groups
Group A: Percutaneous RVOT Stenting
Group B: Surgical RV-PA Conduit

Trial outcomes

Primary outcomes

1

Change in systemic oxygen saturation

Mean change in resting systemic oxygen saturation (SpO2) in percentage from baseline to 12 months.

Time frame
At 12 months

Secondary outcomes

1

Change in peak RVOT gradient

Mean change in peak right ventricular outflow tract gradient in mmHg measured by echocardiography.

Time frame
At 12 months
2

Change in TAPSE

Mean change in tricuspid annular plane systolic excursion (TAPSE) in millimeters measured by echocardiography.

Time frame
At 12 months
3

Number of patients with improvement in NYHA class

Number of patients showing improvement of at least one New York Heart Association functional class.

Time frame
At 12 months
4

Length of hospital stay

Mean length of hospital stay in days after the index procedure.

Time frame
At 1 month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: