Advertisement

Topics

Safety and Effectiveness of the Device Nit-Occlud® PDA-R

2014-07-23 21:10:47 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and the effectiveness of the device Nit-Occlud® PDA-R in the percutaneous closure of patent ductus.

Description

During the years 2003 to 2008, Kardiozentrum evaluated 1136 patients with echocardiographic studies, 14.7% of the patients were diagnosed with patent ductus arterious (PDA). The device "Nit- occlud® PDA-R" is a medical implant, developed for closure of patent ductus arterious (PDA) or ductus, which is an abnormal communication between the aorta and pulmonary artery. Untreated it can rise the intrapulmonary pressure and lead to serious complications like cardiac insufficiency.

The incidence of ductus as an isolated heart disease is between 3,6 and 7% of all the congenital heart diseases at sea level, and 10 - 14% in the altitude; rising up to 20% in cities at more than 2.500 m about sea level. The ductus' in high altitude are generally wider and larger than at sea level.

The device performs the function of generating the defect occlusion by the body itself. The implant stimulates the body to generate an epithelium over the implant so that the ductus closes. The Nit Occlud® PDA-R system is placed inside of the great arteries with a technique called minimally invasive cardiac catheterization. The implementation of the Nit-occlud® PDA-R system is developed for closure of patent ductus with 2 to 8 mm minimal diameter.

Study Design

Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Congenital Heart Disease

Intervention

Nit-Occlud® PDA-R

Location

Kardiozentrum and Surgical Medical Center Boliviano Belga
La Paz
Murillo
Bolivia
100

Status

Recruiting

Source

pfm S.R.L.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:47-0400

Clinical Trials [1937 Associated Clinical Trials listed on BioPortfolio]

Safety and Effectiveness of the Nit-Occlud® Lê VSD Spiral Coil System

The Ventricular septal defect (VSD) is the most common of all congenital cardiac malformations. By modifying the Nit-Occlud® PDA Device the Nit-Occlud® Lê VSD Spiral System was designed...

Congenital Heart Disease Research Registry

The Congenital Heart Disease Research Registry (CHDRR) is a program dedicated to understanding the etiology and improving the treatment of Congenital Heart Disease (CHD). This Registry wil...

Risk Factors for Acquired Cardiovascular Disease in Adults With Congenital Heart Disease

This research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. This knowledge is important to develop and target ways to prevent...

Heart Failure in Adult Patients With a History of Congenital Heart Disease

In today's world of advanced surgery, children born with congenital heart disease (CHD) are surviving into adulthood. However, the surgical procedures these children undergo do not cure th...

Coxsackie Virus in Pregnancy and Congenital Heart Disease

Investigators would like to find out if a woman's exposure to Coxsackievirus has an effect or increase in incidence of babies being born with congenital heart disease(CHD)

PubMed Articles [18582 Associated PubMed Articles listed on BioPortfolio]

Hospital resource utilization and presence of advance directives at the end of life for adults with congenital heart disease.

Overall health care resource utilization by adults with congenital heart disease has increased dramatically in the past two decades, yet little is known about utilization patterns at the end of life. ...

Bioelectrical impedance analysis in the management of heart failure in adult patients with congenital heart disease.

The recognition of fluid retention is critical in treating heart failure (HF). Bioelectrical impedance analysis (BIA) is a well-known noninvasive method; however, data on its role in managing patients...

Prospective cohort study of C-reactive protein as a predictor of clinical events in adults with congenital heart disease: results of the Boston adult congenital heart disease biobank.

Despite the well-defined association of high-sensitivity hsCRP with cardiovascular outcomes in apparently healthy adults and those with acquired heart disease, the relevance of this inflammatory marke...

Educational achievement of children with congenital heart disease: Promising results from a survey by the German National Register of Congenital Heart Defects.

Survival rates of children with congenital heart disease (CHD) have increased significantly in the decade. There is now increased interest in the long-term outcome and quality of life of these childre...

Efficiency of the home cardiac rehabilitation program for adults with complex congenital heart disease.

We aimed to study the efficiency and safety of once-a-week outpatient rehabilitation followed by home program with tele-monitoring in patients with complex cyanotic congenital heart disease.

Medical and Biotech [MESH] Definitions

Cardiac manifestation of systemic rheumatological conditions, such as RHEUMATIC FEVER. Rheumatic heart disease can involve any part the heart, most often the HEART VALVES and the ENDOCARDIUM.

Occlusion of the outflow tract in either the LEFT VENTRICLE or the RIGHT VENTRICLE of the heart. This may result from CONGENITAL HEART DEFECTS, predisposing heart diseases, complications of surgery, or HEART NEOPLASMS.

A congenital coronary vessel anomaly in which the left main CORONARY ARTERY originates from the PULMONARY ARTERY instead of from AORTA. The congenital heart defect typically results in coronary artery FISTULA; LEFT-SIDED HEART FAILURE and MITRAL VALVE INSUFFICIENCY during the first months of life.

Disease-related laceration or tearing of tissues of the heart, including the free-wall MYOCARDIUM; HEART SEPTUM; PAPILLARY MUSCLES; CHORDAE TENDINEAE; and any of the HEART VALVES. Pathological rupture usually results from myocardial infarction (HEART RUPTURE, POST-INFARCTION).

Inflammation of the ENDOCARDIUM caused by BACTERIA that entered the bloodstream. The strains of bacteria vary with predisposing factors, such as CONGENITAL HEART DEFECTS; HEART VALVE DISEASES; HEART VALVE PROSTHESIS IMPLANTATION; or intravenous drug use.

More From BioPortfolio on "Safety and Effectiveness of the Device Nit-Occlud® PDA-R"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...


Searches Linking to this Trial