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Heart Septal Defects, Atrial clinical trials

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NCT ID: NCT01218607 Completed - Clinical trials for Heart Septal Defects, Atrial

Bosentan for Mild Pulmonary Vascular Disease in Asd Patients.

BOMPA
Start date: October 2010
Phase: Phase 3
Study type: Interventional

Volume overload due to left-to-right shunting in patients with atrial septal defect type secundum causes pulmonary vascular disease over a long period of time. Pulmonary vascular resistance can be assessed non-invasively using bicycle stress echocardiography. By measuring cardiac output and pulmonary artery pressures at different stages of exercise, a pressure-output plot can be obtained. The slope of the pressure-output plot reflects pulmonary vascular resistance. In patients undergoing ASD repair after the age of 40 years, pulmonary vascular resistance was higher when compared to age-matched controls, indicating the presence of mild pulmonary vascular disease. Bosentan has been shown to decrease pulmonary vascular resistance. The investigators hypothesize that in patients with an ASD type secundum, who underwent ASD repair after the age of 40 years, administration of bosentan decreases pulmonary vascular resistance as assessed by bicycle stress echocardiography.

NCT ID: NCT01120964 Completed - Clinical trials for Atrial Septal Defect

Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol

Start date: September 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery. Participants will be randomly assigned to either L-citrulline or a placebo (a substance that has no medicine in it). Citrulline is a protein building block in the body that can convert into another substance, nitric oxide (NO), which controls blood pressure in the lungs. Increased blood pressure in the lungs can be an important surgical problem; it may also lead to problems following surgery, such as severe high blood pressure in the lungs (pulmonary hypertension), increased time spent on a breathing machine, and a longer stay in the intensive care unit (ICU). The hypothesis of this study is that perioperative supplementation with intravenous citrulline will increase plasma citrulline, arginine and NO metabolites and prevent elevations in the postoperative PVT leading to a decrease in the duration of postoperative invasive mechanical ventilation. The objective of this study is to determine in a randomized placebo controlled phase IB multicenter clinical trial if a revised protocol of intravenous L-citrulline delivery given perioperatively achieves a plasma citrulline level of > 100 umol/L in children undergoing surgical repair of an atrial septal defect,ventricular septal defect or an atrioventricular septal defect.

NCT ID: NCT01086046 Recruiting - Thrombosis Clinical Trials

Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure

Start date: January 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate blood clots after Percutaneous ASD Closure in different age, sexuality and defective diameter; evaluating the relationship of blood clotting with Occluder, injury of intima and inflammation;comparation of the effect and safety between different anticoagulation after Percutaneous ASD Repair; explore propose an optimal anticoagulation plan.

NCT ID: NCT01068366 Terminated - Clinical trials for Patent Foramen Ovale

Nickel Allergy With Septal Closure Devices

NASAH
Start date: February 2010
Phase: N/A
Study type: Observational

This study is for patients who have been diagnosed with either a Patent Foramen Ovale [PFO] or an Atrial Septal Defect [ASD]. These are a type of hole located in the wall that separates the top two (2) chambers of the heart. You have been recommended to receive an atrial septal occluder device [a device specifically designed to close PFOs and ASDs] implanted in your heart to close this hole. Because these devices are made of materials that contain nickel, this trial is being conducted to perform blood nickel tests on those patients already referred for an atrial septal occluder device such as yourself. The purpose of this study is to compare levels of nickel in the blood in patients receiving either the Amplatzer or the Helex devices.

NCT ID: NCT00968032 Completed - Clinical trials for Foramen Ovale, Patent

Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System

09k003
Start date: July 2009
Phase: N/A
Study type: Interventional

The foramen ovale is an opening in the interatrial septum. It results from an incomplete coverage of the ostium secundum. In 10 to 24% of the general population incomplete fibrosis of the interatrial septum is a clinical finding and is defined as a patent foramen ovale (PFO). The Nit-Occlud® PFO umbrella is a permanent implant for closing PFOs that is implanted in the PFO using minimally invasive catheter technology. The umbrella is made from Nitinol, a material with superelastic properties, which, in its relaxed state, has the form of a double umbrella. This is a single-center, non-comparative, prospective interventional clinical investigation involving 1 center in Germany to assess the effectiveness, safety and practicability of implantation of the Nit-Occlud PFO® Closure Device.

NCT ID: NCT00799045 Completed - Migraine Clinical Trials

Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects

CANOA
Start date: October 2008
Phase: Phase 4
Study type: Interventional

The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.

NCT ID: NCT00650936 Completed - Clinical trials for Atrial Septal Defect

Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study

Start date: August 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder

NCT ID: NCT00581308 Completed - Clinical trials for Septal Defect, Atrial

Long-term Safety Study of the GORE® HELEX® Septal Occluder

Start date: August 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).

NCT ID: NCT00498446 Completed - Clinical trials for Atrial Septal Defect

Magnetic Resonance Imaging of Atrial Septal Defects

Start date: July 2002
Phase:
Study type: Observational

An atrial septal defect (ASD) is a hole in the heart that can lead to heart failure. Depending on the size and severity of the ASD, They can be treated during a heart catheterization with a special device that can permanently seal the ASD, but knowing the exact size and severity of the ASD is crucial. Newer MRI techniques may provide a better way at diagnosing the size and severity of an ASD. We compared MRI to other standard clinical ways for evaluating an ASD.

NCT ID: NCT00480740 Completed - Clinical trials for Atrial Septal Defect

The Pharmacology and Hemodynamics of Dexmedetomidine in Children With Congenital Heart Disease

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.