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Heart Block clinical trials

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NCT ID: NCT03309956 Completed - Clinical trials for Arrhythmias, Cardiac

Holter Versus Zio Patch Electrocardiographic Monitoring in Children

Start date: October 18, 2017
Phase: N/A
Study type: Interventional

This prospective study aims to compare the diagnostic yield, or ability to detect an arrhythmia, of the traditional Holter monitor versus the novel Zio patch monitor in pediatric patients referred for ambulatory electrocardiographic (ECG) monitoring. Children will wear both devices simultaneously for 48 hours and the incidence of clinically significant arrhythmias will be compared.

NCT ID: NCT03157297 Completed - Clinical trials for Atrioventricular Conduction Block

Micra Atrial Tracking Using a Ventricular Accelerometer Study

MARVEL
Start date: July 10, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize performance of the MARVEL algorithm downloaded into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV block. A sub-study will be conducted within the Marvel study, the purpose of this study is to characterize the MARVEL algorithm in patients who were enrolled in the MARVEL study, and to collect and compare the accelerometer signals and AV synchrony at a second point in time.

NCT ID: NCT02920346 Completed - Sjogren's Syndrome Clinical Trials

Prospective Maternal Surveillance of SSA (Sjögren Syndrome A) Positive Pregnancies Using a Hand-held Fetal Heart Rate Monitor

Start date: March 2014
Phase:
Study type: Observational

The purpose of the research study "Heart Sounds at Home" is for pregnant SSA or SSA/SSB (Sjögren syndrome B) antibody positive mothers to use a Doppler fetal heart rate monitor to detect abnormal heart rates and rhythms in their babies before they are born.

NCT ID: NCT02809131 Completed - Syncope Clinical Trials

Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.

ENVELOPE
Start date: April 1, 2016
Phase: Phase 3
Study type: Interventional

The number of cardiac implantable electronic devices (CIEDs) implanted each year has grown rapidly over the past two decades. CIED infections, defined as infections involving the generator implant site (pocket) and/or intravascular leads, have become increasingly prevalent, with the rate of growth in infections outpacing that of CIED procedures. The odds of both short term and long term mortality are at least doubled in patients who suffer CIED infections, and long term survival is particularly poor in women. Optimal strategies to prevent CIED infections in high-risk patients are largely unproven. However, recent observational studies of an antibiotic-coated envelope implanted at the time of CIED procedure have shown that this strategy is associated with a low incidence of CIED infections. Other interventions to prevent CIED infections, including the use of antibiotic irrigant used to wash the pocket during implantation and postoperative oral antibiotics, are commonly used but not supported by rigorous controlled studies. The Specific Aim of this study is to test the hypothesis that the use of the antibacterial envelope alone is noninferior to a strategy using the antibacterial envelope and intraoperative antibacterial irrigant and postoperative oral antibiotics for the reduction of cardiac implantable device infections in patients with ≥2 risk factors for infection.

NCT ID: NCT02636712 Completed - Vasovagal Syncope Clinical Trials

Observation of ImageReady™ MR Conditional Pacing System in China

Start date: December 8, 2015
Phase:
Study type: Observational

To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects

NCT ID: NCT01983293 Completed - Clinical trials for Non-left Bundle Branch Block

CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients

ENHANCE CRT
Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to analyze the effect of left ventricular lead pacing location in the non-left bundle branch block (non-LBBB) heart failure patient population. The left ventricular lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.

NCT ID: NCT01480908 Completed - Clinical trials for Heart Septal Defects, Ventricular

Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect

Start date: June 2011
Phase: N/A
Study type: Interventional

The most common congenital heart disease is the ventricular septal defect, and after surgical closure of a such defect, an arrythmia called the right bundle branch block, is very frequent. Therefore the aim of this study is to investigate if this group of patients has inferior outcomes compared to the group without this arrythmia after surgical closure and compared to a group of healthy control subjects. All patients will be undergoing 1. exercise testing, 2. echocardiography, 3. echocardiography during exercise, and 4. MRI. The perspective is the ability to point out a group of patients with a possible need of further intervention, and additionally to increase the awareness of protecting the electrical system of the heart during the operation.

NCT ID: NCT01423994 Completed - Syncope Clinical Trials

Syncope: Pacing or Recording in the Later Years

Spritely
Start date: August 2011
Phase: Phase 4
Study type: Interventional

Syncope affects about 50% of Canadians, is the cause of 1 - 2% of all emergency room visits, and probably is responsible for CDN $250 million in health care spending each year. It is associated with decreased quality of life, trauma, loss of employment, and limitations in daily activities. It is a particular problem for older people, partly because of increased frailty, and partly because of a difficult differential diagnosis. One of the causes in older adults is intermittent complete heart block in the setting of bifascicular heart block, but they may also faint due to a variety of tachyarrhythmias, sick sinus syndrome, and several neurally mediated syncopes. Often treatment decisions should be made before the true cause is apparent.

NCT ID: NCT01379573 Completed - Neonatal Lupus Clinical Trials

Preventive Approach to Congenital Heart Block With Hydroxychloroquine

PATCH
Start date: January 1, 2011
Phase: Phase 2
Study type: Interventional

Women with antibodies to proteins called SSA/Ro and or SSB/La face a 2% chance of having a child with a life threatening heart condition regardless of whether they have very active lupus, are in remission, or have only vague symptoms. This heart problem is referred to as congenital heart block (the most serious being third degree complete block) and represents damage thought to be caused by these autoantibodies. The heart beats abnormally slowly and almost all children require permanent pacemakers before the age of 20. Importantly, women who have had one child with heart block have a ten-fold higher risk of having another child with the same heart condition. Unfortunately, even close monitoring by special techniques during pregnancy does not reverse complete heart block once it is observed. Thus, treatments aimed at prevention are critical. This study will evaluate for the first time whether hydroxychloroquine, a drug used by many patients with SLE, prevents the development of this heart condition. Data from laboratory experiments suggests that this drug, which crosses the placenta, may decrease the inflammation initiated by the passage of anti-Ro antibodies to the fetus. The study uses a Simon's 2-Stage design, and plans to enroll 19 patients in Stage 1 and 35 patients in Stage 2 if Stage 1 is successful. Patients can already be on hydroxychloroquine or will be started as soon as pregnancy is confirmed. The hope is that fewer than 3 cases of heart block will occur in Stage 1, and fewer than 6 cases will occur out of all 54 patients if Stage 2 is reached. The results of this study are expected to become an integral part of the counseling of women with anti-Ro/La antibodies who are considering pregnancy.

NCT ID: NCT01169493 Completed - Heart Failure Clinical Trials

Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial)

PACE-RBBB
Start date: January 2011
Phase: N/A
Study type: Interventional

Heart failure (HF) affects 5 million Americans and is responsible for more health-care expenditure than any other medical diagnosis. Approximately half of all HF patients have electrocardiographic prolongation of the QRS interval and ventricular dyssynchrony, a perturbation of the normal pattern of ventricular contraction that reduces the efficiency of ventricular work. Ventricular dyssynchrony is directly responsible for worsening HF symptomatology in this subset of patients. Resynchronization of ventricular contraction is usually achieved through simultaneous pacing of the left and right ventricles using a biventricular (BiV) pacemaker or implantable cardioverter-defibrillator. Clinical trial evidence supporting the use of BiV pacing in patients with prolonged QRS duration was obtained almost exclusively in patients with a left bundle-branch block (LBBB) electrocardiographic pattern. Recent evidence suggests that resynchronization of ventricular contraction in patients with LBBB can be obtained by univentricular left ventricular pacing with equal or superior clinical benefits compared to BiV pacing. Animal studies suggest that ventricular resynchronization can be obtained in subjects with right bundle-branch block (RBBB) through univentricular right ventricular pacing. No clinical trial evidence exists to support the use of BiV pacing in patients with RBBB. Thousands of patients with symptomatic HF and RBBB currently have univentricular ICDs in place for the prevention of sudden cardiac death. Most of these devices are currently programmed to avoid RV pacing. We aim to determine if ventricular resynchronization delivered through univentricular RV pacing improves symptoms in patients with RBBB and moderate to severe HF who have previously undergone BiV ICD implantation for symptomatic heart failure. We further aim to determine if ventricular resynchronization improves myocardial performance and ventricular geometry as detected by echocardiographic measures and quality of life for patients with HF and RBBB. We hypothesize that RV univentricular pacing delivered with an atrio-ventricular interval that maximizes ventricular synchrony is equivalent to BiV pacing for improvement in cardiac performance, HF symptoms, and positive ventricular remodeling in patients with HF and RBBB.