View clinical trials related to Bradycardia.
Filter by:The treatment of chronic bradycardia, one of the cardiovascular diseases, remains an essential unsolved issue. The objective of this project is to speed up a new drug CARDIX-101 clinical Phase 1IA trial for the treatment of chronic bradycardia and to solve an unmet medical need. To date, there is no regulatory approved drug of this type available in the U.S or the world. If the new drug CARDIX-101 demonstrated a significant positive effect on chronic bradycardia, it should have a sizeable demand and solve an unmet medical need.
This is a multicenter randomized controlled study. By comparing patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation and pacemaker therapy, and long-term follow-up to evaluate its safety and effectiveness after surgery, in order to evaluate the safety and effectiveness of cardiac autonomic ganglion ablation in the treatment of sinus bradycardia.
Purpose of Study: Apnoea of Prematurity (AOP) is common, affecting the majority of infants born <34 weeks gestational age (GA). Apnea is accompanied by intermittent hypoxia (IH), which contributes to multiple pathologies, including retinopathy of prematurity (ROP), sympathetic ganglia injury, impaired pancreatic islet cell and bone development, and neurodevelopmental disabilities. Standard of care for AOP/IH includes prone positioning, positive pressure ventilation, and caffeine therapy. The objective of this device is to provide an adjunct to current AoP treatment to support breathing in premature infants by using a simple, non-invasive vibratory device placed over limb proprioceptor fibers, an intervention using the principle that limb movements facilitate breathing. Methods Used: Premature infants (27+6 - 34+6 weeks GA) with clinical confirmed weeks with diagnosis of Apnoea of Prematurity. Caffeine therapy was not a reason for exclusion. Small vibration devices were placed on one hand and one foot and activated in a 6 hour ON/OFF sequence for a total of 24 hours. Heart rate, respiratory rate, oxygen saturation (SpO2), and breathing pauses were continuously collected.
BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand, treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and pro-arrhythmia/sudden death which may be amplified by concomitant use of other QTc-prolonging drugs and/or ion disbalances. COVIDAR is an international initiative to monitor the occurrence of arrhythmic events in the context of the SARS-CoV2 infection, to identify potential modifiable predisposing factors to reduce their incidence and to inform the best arrhythmia management options in this patient population. MAIN OBJECTIVE: To describe the incidence and type of arrhythmic events in the context of the SARS-CoV2 infection. STUDY DESIGN: patient registry (observational). Patients will not undergo any additional investigations. Only data that is generated during routine clinical care will be collected. STUDY POPULATION: Patients admitted to the hospital highly suspected of or with confirmed COVID-19.
Particularly in CRT (Cardiac Resynchronisation Therapy), limited accessibility of the coronary sinus along with its branches and the mismatch between the region of latest left ventricular (LV) contraction and an adequate epimyocardial vein frequently lead to therapy failure and might even be responsible for the 30 % non-responders, although this aspect has not been thoroughly investigated yet. Further complications such as postoperative micro- (i.e. increased thresholds) or macro-dislodgement (i.e. loss of stimulation success) of the LV electrodes are frequent complications leading to reoperation or a change of strategy. The current transthoracic epimyocardial approach via mini-thoracotomy circumvents the aforesaid obstacles and is regarded as the first-choice alternative approach. Participation in the trial would prevent patients from this invasive, transthoracic approach and at the same time allow the same degree of freedom in lead placement. Risks and complications are in this case comparable to the open surgical approach but with a lower risk of intraoperative rib fracture, postoperative pain with consecutive pulmonary hypo-ventilation and pneumonia. Apart from the benefit of the single individual, societies benefit will include a much higher responder rate in CRT patients and less lead-associated infections. Thoracotomy with breach of the pleural cavity and single lung ventilation - a procedure that itself bears a high risk for postoperative atelectasis, pleural effusion and infection will be avoided. In patients on hemo-dialysis and patients who suffer from an infected pacemaker-system, extravascular lead placement should be preferred. Again, the current open, transthoracic epimyocardial approach via mini-thoracotomy is regarded as the first-choice alternative approach. Aim of this study is the validation of the feasibility of an alternative, minimal-invasive therapy method for implanting a cardiac pacemaker.
Intranasal injection of epinephrine is used routinely during endoscopic sinus surgery (ESS) to reduce bleeding in the nasal mucosa and thereby improve visualization of the surgical field. However, systemic absorption of epinephrine via the nasal mucosa is often accompanied by cardiovascular side effects during the early postinjection period, putting in risk patients with cardiovascular morbidity. Evidence indicate that topical administration of epinephrine achieves similar hemostatic effects compared with injection of epinephrine, while avoiding systemic adverse effects. We wish to conduct a prospective controlled trial assessing the hemostatic and hemodynamic effects of intranasal injection compared to topical application of epinephrin during ESS, in order to evaluate whether the previous could be avoided due to its untoward effects. We hypothesize that topical administration of epinephrine provides a hemostatic effect not inferior to that of intranasal injection while minimizing hemodynamic instability during ESS.