This trial is evaluating whether Left bundle branch pacing lead (Select Secure 3830 lead) will improve 3 primary outcomes and 11 secondary outcomes in patients with Heart Block. Measurement will happen over the course of 30 days.
This trial requires 100 total participants across 2 different treatment groups
This trial involves 2 different treatments. Left Bundle Branch Pacing Lead (Select Secure 3830 Lead) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
"Treatment is focused on symptom management rather than a cure for the underlying disease, which can be treated through many forms of therapy. It was difficult to identify specific therapies for any condition." - Anonymous Online Contributor
"Heart block can have many causes ranging from benign changes, to serious, sometimes fatal condition of the heart muscle. Most causes related to the heart can be traced to arrhythmias or the abnormalities related to the electrical conduction system of the heart, the bundle of hearts." - Anonymous Online Contributor
"In cases treated by PACE, there was a significant and statistically significant trend toward a lower risk of recurrent block or death in patients with complete heart block compared with patients with a remaining first-degree block." - Anonymous Online Contributor
"Heart block results from an interruption in the electrical conduction system of the heart. Most blocks originate in the sinoatrial node, although other sites, such as the atrioventricular node and bundle branches, also play an active role.\n" - Anonymous Online Contributor
"Signs of heart block include chest pain, a feeling of pressure or discomfort in the chest, blurred vision, and weakness in the face or legs.\n" - Anonymous Online Contributor
"Approximately 6,200 Americans will develop bradycardia each year due to heart block. The age-adjusted risk was highest in the second- to fifth-decade age groups (10.0-4.6%) but was much higher in younger age groups (42.8%). Women (16.6%) and blacks (14.6%) are more likely to develop heart block than whites (7.2%)." - Anonymous Online Contributor
"Most patients with secondary heart block have a prolonged PR interval, in contrast to patients with primary heart block. Myocardial fibrosis may explain the higher incidence of primary versus secondary heart block in these two groups. The low degree of QRS distortion in the majority of cases suggests that an early termination of this distortion process could be responsible for the occurrence of the more severe form of arrhythmia." - Anonymous Online Contributor
"Select Secure leads demonstrate improved lead integrity and safety compared with standard Secure leads. Use of a selective Secure lead in patients with significant heart block is being increasingly accepted and is well tolerated. Our first results show that using a Select Secure lead in the treatment of left bundle branch block could be beneficial. The current generation of Select Secure leads has become a tool for therapeutic intervention in patients with significant heart block in a variety of clinical applications." - Anonymous Online Contributor
"Use of a 3830 leads with LVAP leads is safe and effective in stimulating left ventricular function. These leads exhibit fewer side effects and are more economical compared to the use of conventional leads." - Anonymous Online Contributor
"Most patients get heart block at a younger age (i.e., under 40) than they think they do. Younger patients tend to overestimate the true frequency of the heart block they are getting and thus over-treat for the symptoms of the disease." - Anonymous Online Contributor
"LV BBR pacing leads are safe and effective for people with LV dysfunction and LV lead complications are low. A small percentage may experience some lead problems. It should not be surprising that no lead problems occurred in patients who had all three of the following complications: no pacing leads in place, no P-wave progression, and no P-wave axis >160 deg." - Anonymous Online Contributor
"A substantial minority of patients with left bundle branch block may be eligible for clinical trials. Those with mild or moderate symptoms with no evidence of disease, and those who are asymptomatic with nonspecific ECGs, should strongly be considered for therapeutic clinical trials. Because of the limitations in the numbers of patients in clinical trials, a large enough sample size is needed before determining the benefit of one treatment modality in comparison with another. The presence of other heart disease is a contraindication to participation in clinical trials." - Anonymous Online Contributor