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Heart Block clinical trials

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NCT ID: NCT00460928 Completed - Neonatal Lupus Clinical Trials

Preventive IVIG Therapy for Congenital Heart Block

PITCH
Start date: April 2007
Phase: Early Phase 1
Study type: Interventional

Neonatal lupus (NL) is the name given to a group of conditions that can affect the babies of mothers who have certain autoantibodies against components of the body's cells that are called SSA/Ro and SSB/La. NL can appear as a temporary rash that usually goes away by the time the baby is 6 months old, or very rarely an abnormal blood or liver condition that also improves with time - or it can cause permanent and often life-threatening damage to the fetal heart, known as congenital heart block (CHB). In women with anti-Ro/La antibodies who are pregnant for the first time, only about 2% of the babies will develop CHB. But for a woman who has already had a child with CHB or NL rash, the risk of CHB in her next pregnancy is nearly 20%. Unfortunately, once complete (third degree) heart block has been unequivocally identified in a fetus, it has never been reversed with any of the therapies that have been tried to date. Our previous studies strongly indicate that scarring of the conduction system (the heart's own natural "pacemaker"), a consequence of inflammation triggered by the mother's antibodies, damages or even destroys the cells that allow the heart to beat at a normal rhythm. Instead, the damaged heart beats extremely slowly, to an extent that is fatal to nearly 20% of affected babies (with most deaths occurring as fetal demises). Nearly all surviving children with CHB require permanent implantation of a pacemaker device. Because it is so difficult to treat or repair the damaged heart, a high-priority strategy is to try to prevent the inflammatory process before irreversible scarring can occur. The aim of this clinical-based proposal is to determine whether treating the pregnant mother with intravenous immune globulin (IVIG) will prevent the development of CHB.

NCT ID: NCT00382525 Completed - Heart Failure Clinical Trials

PANORAMA Observational Study

Start date: January 2005
Phase: N/A
Study type: Observational

To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with or without cardiac resynchronization therapy), implantable loop recorders and leads used within their intended use. Clinical variables will be analyzed in relation to device-based data and diagnostics.

NCT ID: NCT00374608 Completed - Pacemaker Clinical Trials

Exercise in Chronically Paced Children

Start date: January 2007
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the exercise capacity of patients with complete heart block who are chronically being paced from the right ventricle. Also, we hope to correlate the level of uncoordinated contraction with the patients exercise capacity. We will enroll patients with complete heart block as diagnosed by standard electrocardiographic means and now have a permanent pacemaker. All patients we approach for this study will receive an echocardiogram to assess their heart function. As part of the echocardiogram, they will also receive a Tissue Synchronization Imaging (TSI) evaluation to assess the level of uncoordinated contraction they have. The patients will then be subjected to a cardiac exercise stress test which will involve them running on a treadmill until they cannot continue while data is collected regarding their heart's response to exercise. All portions of the study are noninvasive, which means they work from probes and monitors outside the body.

NCT ID: NCT00292539 Completed - Atrial Fibrillation Clinical Trials

Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class

Start date: February 2006
Phase: N/A
Study type: Observational

This registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left ventricular ejection fraction shall be documented.

NCT ID: NCT00286858 Completed - Bradycardia Clinical Trials

Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing

Start date: September 2006
Phase:
Study type: Observational

This study shall evaluate in daily medical practice the clinical results of the AV delay hysteresis search algorithm in patients with a INSIGNIA ULTRA or AVT pacemaker implanted for one of the three following indications: sinus node dysfunction, atrial disease (or bradycardia/tachycardia) and atrio-ventricular paroxysmal block. In addition use and outcome of automatic functions will be evaluated.

NCT ID: NCT00269659 Completed - Heart Failure Clinical Trials

Evaluating Effects of a Left Bundle Branch Block

Start date: January 2004
Phase: Phase 3
Study type: Observational

A left bundle branch block (LBBB) is related to abnormal cardiac conduction and mechanical asynchrony and is associated with hypertension and coronary artery disease. Improved evaluation of left ventricular (LV) mechanical asynchrony is needed, because of the increasing number of patients with a LBBB and heart failure. A variety of patterns of mechanical activation can be observed in LBBB patients. Novel imaging modalities such as tissue Doppler imaging, real-time 3D echocardiography and cardiovascular magnetic resonance imaging provide information about regional and global LV function in healthy subjects, patients without a LBBB with heart failure, patients with a LBBB without heart failure, and patients with a LBBB with heart failure. The investigators want to evaluate the different patient groups with the novel imaging modalities and they want to compare the novel imaging modalities with each other. The investigators hypothesized that, between the groups, differences concerning regional and global LV function are measurable. Each novel imaging technique has its own advantages and limitations but are comparable in measuring regional and global LV function.

NCT ID: NCT00180557 Completed - Bradycardia Clinical Trials

Austria Study - Analysis of Difference Between Active and Passive Fixation Leads

Start date: September 2003
Phase: Phase 4
Study type: Interventional

In this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated. In addition the influence of the stimulation location by type of lead on QRS width, ejection fraction and NYHA class will be evaluated using and electrocardiogram and echocardiogram.

NCT ID: NCT00074373 Completed - Clinical trials for Systemic Lupus Erythematosus

The Research Registry for Neonatal Lupus

Start date: May 27, 2010
Phase:
Study type: Observational

Women with lupus and other related disorders produce certain antibodies in the blood. Some women have these antibodies even if they have not yet developed symptoms of lupus or Sjogren's syndrome. When these women become pregnant, they may pass the antibodies to their infants. The infants may then develop a disease called neonatal lupus. The symptoms of neonatal lupus include an abnormally slow heart beat (heart block) and a skin rash. This registry collects information on women and infants affected by neonatal lupus as well as other family members who may be healthy.

NCT ID: NCT00007358 Completed - Myocardial Injury Clinical Trials

Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus

Start date: October 2000
Phase: N/A
Study type: Interventional

Some newborns are born with congenital heart block (CHB), a condition occurring in babies with neonatal lupus. The first part of the study will test the effectiveness of fluorinated steroids, including dexamethasone, in improving the heart function and general health of newborns who have auto-antibody-associated CHB. The second part of this study will use ultrasound and heart monitoring to observe high-risk pregnant women and their fetuses during the third trimester of pregnancy.