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Fontan Operation clinical trials

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NCT ID: NCT05474664 Not yet recruiting - Fontan Operation Clinical Trials

Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

Start date: August 1, 2022
Phase: Phase 2
Study type: Interventional

This study is phase 2 open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of Camostat mesylate in patients with Protein-losing enteropathy after Fontan operation.

NCT ID: NCT02414321 Recruiting - Clinical trials for Congenital Heart Disease

The Role of the Pulmonary Vasculature in the Fontan Circulation

Start date: June 2015
Phase:
Study type: Observational

This study aims to explore the structural and functional characteristics of the pulmonary vasculature in adult Fontan patients. Objectives: - Determine the effect of pulmonary vasodilatation on indexed cardiac output during simulated exercise. - Characterization of structural properties of small pulmonary arteries.

NCT ID: NCT02269709 Completed - Fontan Operation Clinical Trials

Stage 3 Fontan Operation Liver Ultrasound Study

Start date: November 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the liver stiffness, which can be caused by congestion and fibrosis in pediatric patients before and after a Fontan heart operation. A new form of ultrasound elastography (Acoustic Radiation Force Impulse, or ARFI) will measure liver stiffness.

NCT ID: NCT01413308 Enrolling by invitation - Fontan Operation Clinical Trials

Pulmonary Functions Test in Patients After Fontan Operation

Start date: September 2011
Phase: N/A
Study type: Observational

Developed in the early 1970s, Fontan Operation has provided palliative care for patients with single ventricle physiology. Single ventricle is a rare subclass of the atrioventricular (AV) alignment abnormalities double inlet and common inlet ventricles (and rarely, straddling tricuspid valve), in which there is only one ventricular sinus [1]. Most patients present with symptoms of congestion , low cardiac output, and deep cyanosis immedietly after birth. Untreated, these heart anomalies are highly lethal. Neonatal heart transplantation is implacable because of shortage of donors. Fontan operation is a three staged palliative procedure: the single ventricle pumping blood to the systemic circulation , while blood flows laminarly to the lungs through direct anastomosis of the superior and inferior vena cavae (total cavo pulmonary connections), inevitably by-passing the right heart . This procedure has been shown to immediately correct the mixed venous blood dysfunction, providing treatment for the prominent signs of cyanosis. Along with its beneficial outcomes, Fontan circulation patients have been documented to have a variety of post-operative late complications. Of most substantial, increased systemic vascular resistance (mean of 10-15 mmHg higher) [2], systolic dysfunction as a result of decreased preload and increase afterload [3], and atrial arrhythmias [4]. With the advent of bypassing right-heart circulation with Fontan operation, the pulmonary vascular bed is exposed to a new atmosphere of blood flow. Instead of physiological pulsatile flow in normal circulation, the pulmonary vasculature is receiving slow velocity, laminar flow [5]. Patients post-Fontan operations have been documented to have restrictive-type pulmonary function, but still yet to be correlated with Fontan circulation or as a possible result of prior lung tissue injury from the pre/intra-operation high volume blood flow. Regardless, Fontan patients are described to have decreased pulmonary function. The purpose of this research effort is to document and analyze the pulmonary function of those patients post-Fontan operation. It is still unclear as to what the long-term effects of Fontan operation are towards the pulmonary vascular bed, leaving us questions about the effects on lung capacities, ventilation-perfusion efficiency, and oxygen saturation.