Topics

Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.

2018-10-17 12:26:19 | BioPortfolio

Summary

The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric. This surveillance includes an "all-comers" prospective cohort of pediatric (<22 years of age) patients implanted according to the IFU with the EXCOR® Pediatric.

Description

The Advanced Cardiac Therapies Improving Outcomes Network (Action) database will be used for the surveillance. The network was developed to determine best practice and improve quality in the pediatric mechanical circulatory support field. The registry Protocol and Manual of Operations will be followed by participating pediatric transplant hospitals. Quality assurance of the data will be monitored by the registry's data coordinating center.

Study Design

Conditions

Ventricular Dysfunction

Intervention

EXCOR Pediatric

Location

Sites per Action network
Cincinnati
Ohio
United States
45229

Status

Enrolling by invitation

Source

Berlin Heart, Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-10-17T12:26:19-0400

Clinical Trials [2069 Associated Clinical Trials listed on BioPortfolio]

EXCOR Pediatric Ventricular Assist Device (VAD)

The purpose of the study is to determine whether use of the Berlin Heart EXCOR Pediatric VAD for bridge-to-transplant is associated with a reasonable assurance of safety and probable benef...

EXCOR® Pediatric VAD Anticoagulation IDE

The Berlin Heart EXCOR ventricular assist device received approval from the FDA as a bridge to transplantation for children in 2011. Successful bridge to transplantation or recovery in the...

Pumps for Kids, Infants, and Neonates

PumpKIN is a randomized, multicenter, two-arm trial evaluating the investigational Infant Jarvik 2015 versus the EXCOR® Pediatric VAD in pediatric patients with heart failure. This study ...

Right Ventricular Dysfunction in Cardiac Surgery Patients

To establish the correlation between echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the perio...

Progressive Ventricular Dysfunction Prevention in Pacemaker Patients

The purpose of this pilot study is to evaluate the progression of ventricular dysfunction in patients with ventricular dysfunction within the permanent pacing population.

PubMed Articles [8665 Associated PubMed Articles listed on BioPortfolio]

Implantation of the Berlin Heart EXCOR ventricular assist device.

The Berlin Heart EXCOR® is a mechanical, pulsatile ventricular assist device. The paracorporeal assist device is pneumatically driven and can be used for long-term bridging therapy of one or both ven...

New or Persistent Right Ventricular Systolic Dysfunction Is Associated With Worse Outcomes in Pediatric Acute Respiratory Distress Syndrome.

The trajectory and importance of right ventricular systolic function and pulmonary hypertension during the course of pediatric acute respiratory distress syndrome are unknown. We hypothesized that new...

Cardiac Dysfunction Identified by Strain Echocardiography Is Associated With Illness Severity in Pediatric Sepsis.

Sepsis-induced myocardial dysfunction has been associated with illness severity and mortality in pediatrics. Although early sepsis-induced myocardial dysfunction diagnosis could aid in hemodynamic man...

A rare cause of erectile dysfunction: left ventricular diastolic dysfunction.

The aim of this study was to investigate the association between left ventricular diastolic dysfunction (LVDD) and erectile dysfunction (ED) without overt cardiovascular disease.

Right Ventricular Failure.

Interest in the right ventricle has increased because of advances in pulmonary hypertension treatment, improved diagnostic technology, and increased implantation of left ventricular assist devices and...

Medical and Biotech [MESH] Definitions

Diabetes complications in which VENTRICULAR REMODELING in the absence of CORONARY ATHEROSCLEROSIS and hypertension results in cardiac dysfunctions, typically LEFT VENTRICULAR DYSFUNCTION. The changes also result in myocardial hypertrophy, myocardial necrosis and fibrosis, and collagen deposition due to impaired glucose tolerance.

A condition in which the RIGHT VENTRICLE of the heart was functionally impaired. This condition usually leads to HEART FAILURE or MYOCARDIAL INFARCTION, and other cardiovascular complications. Diagnosis is made by measuring the diminished ejection fraction and a depressed level of motility of the right ventricular wall.

A form of CARDIAC MUSCLE disease that is characterized by ventricular dilation, VENTRICULAR DYSFUNCTION, and HEART FAILURE. Risk factors include SMOKING; ALCOHOL DRINKING; HYPERTENSION; INFECTION; PREGNANCY; and mutations in the LMNA gene encoding LAMIN TYPE A, a NUCLEAR LAMINA protein.

A condition in which the LEFT VENTRICLE of the heart was functionally impaired. This condition usually leads to HEART FAILURE; MYOCARDIAL INFARCTION; and other cardiovascular complications. Diagnosis is made by measuring the diminished ejection fraction and a depressed level of motility of the left ventricular wall.

A potentially lethal cardiac arrhythmia characterized by an extremely rapid, hemodynamically unstable ventricular tachycardia (150-300 beats/min) with a large oscillating sine-wave appearance. If untreated, ventricular flutter typically progresses to VENTRICULAR FIBRILLATION.

More From BioPortfolio on "Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation."

Quick Search

Relevant Topics

Cardiology
Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial