Micra AV Transcatheter Pacing System Post-Approval Registry
BradycardiaMedtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release. The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.
PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
BradycardiaThe primary objective of this study is to evaluate the safety and the electrical performances of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.
Safety and Performance Study of the Moderato System
Hypertension Resistant to Conventional TherapyBradycardia1 moreThe purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce their blood pressure.
"Effects of Manual Lymphatic Drainage in the Neck in Healthy Subjects. Experimental Randomized Crossover...
Blood PressureNervous System Diseases3 moreDrainage manoeuvres described in different Manual Lymphatic Drainage methods, suggest modificactions in vital signs, by changes at nervous system, that would involve modifications to heart rate, breathing rate, blood pressure, cardiac vascular level (arteries and lymphatics). In addition this hypothetical relaxing effect could be beneficial for other types of pathologies associated with the presence of stress, cardiac problems, respiratory pathology, muscle tension, muscle trigger points, etc. With this study investigators compare different manoeuvres in the neck area to observe the results in the participants regarding the basal state.
The Personalized Chinese Herb Formulas Over Hypertensive Bradyarrhythmia
Hypertensive Heart Disease72 patients who have been diagnosed with hypertensive bradyarrhythmia were selected and randomly divided into research group and control group. The research group received regular medication against hypertension and the personalized formulas based on syndrome differentiation, meanwhile the control group only received the regular medication. The five symptoms (palpitation, short of breath, angina, dizzy and lumbar debility) were graded and used for evaluation of treatment.
Promotion of Coronary Collateral Function by Ivabradine-Induced Bradycardia in Patients With Coronary...
Coronary Artery DiseaseThe purpose of this study in patients with chronic stable coronary artery disease treatable by percutaneous coronary intervention (PCI) is to evaluate the long-term efficacy and safety of the orally taken selective I(f)-inhibitor Ivabradine (Procoralan®, Servier Switzerland) with regard to the promotion of collateral growth.
Spontaneous Atrio Ventricular Conduction Preservation
Sinus Node DysfunctionBradycardia-Tachycardia Syndrome1 moreIn case of sinus node dysfunction, it is often necessary to choose the safer option provided by a DDD pacemaker even though the most appropriate mode of pacing is AAI mode. In addition to saving energy, the latter mode allows spontaneous ventricular activation, the haemodynamic consequences of which are, in most cases, better than those obtained with dual chamber pacing. Recent studies as the MOST study suggest also that ventricular desynchronization imposed by right ventricular apical pacing even when AV synchrony is preserved increases the risk of atrial fibrillation in patients with SND. Similar results were already given by anterior studies (PIPAF) which, taking into account the percentage of ventricular pacing, suggested that AF prevention algorithm in combination with a preserved native conduction are efficient in reducing AF burden. However, current practice is to implant a dual chamber pacemaker to prevent the risk of atrioventricular block (AVB) even if DDDR pacing with a fixed long AV delay was found inefficient in reducing ventricular pacing and was associated with a high risk of arrhythmias. The Symphony 2550 cardiac pacemaker offers pacing modes that automatically switch from AAI(R) mode to DDD(R) or DDI(R) in event of severe atrioventricular conduction disorder, irrespective of whether or not these are accompanied by an atrial arrhythmia, returning spontaneously to AAI(R) mode as soon as the spontaneous AV conduction has resumed. These 2 particular modes are called the AAI SafeR and DDD/AMC (R) mode. The main differences between both modes are that (i) AAI SafeR does not trigger any AV Delay after a sensed or paced atrial event which allows long PR intervals or even limited ventricular pauses with no switch to DDD(R), while (ii) DDD/AMC (R) is able to optimize AV Delay after switching to DDD(R) according to measured spontaneous conduction times and to provide an acceleration in case of vaso-vagal syndrome. This pacing mode has previously been assessed in clinical studies. This study intends to demonstrate that the automatic modes switching significantly reduce the percentage of ventricular pacing in patients implanted with a spontaneous AV conduction and reduce the occurrence of atrial arrhythmias, on a mid-term follow-up period, in comparison to standard DDD pacing with long AVDelay.
Study for Atrial Fibrillation Reduction (SAFARI)
Atrial FibrillationBradycardiaAtrial fibrillation (AF), which is the name for rapid beats in the upper chambers of the heart, is the world's most common kind of irregular heart beat. People with AF experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness. Although AF can occur in otherwise healthy people for no apparent reason, it is sometimes associated with high blood pressure, heart disease or lung problems. The purpose of the SAFARI trial is to study the effectiveness of pacing algorithms in the upper chamber of the heart for patients who have both AF and bradycardia (slow heart beat).
Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine...
Spinal AnesthesiaPatients undergoing lower extremity surgery with spinal anesthesia are often sedated to reduce patient discomfort due to large noises during surgery and also to reduce anxiety. Most commonly used sedatives include propofol and midazolam, but these agents are known to often cause hypotension or respiratory depression. Dexmedetomidine is a selective alpha 2 adrenergic drug, which acts as a sedative and also has analgesia effects. In contrast to propofol or midazolam, dexmedetomidine rarely causes respiratory depression, and therefore is often used in critically ill patients in the ICU and also in patients undergoing simple procedures. Hemodynamically, dexmedetomidine evokes a biphasic blood pressure response with a short hypertensive phase and subsequent hypotension. Bradycardia is also observed in many patients, which may lead to more serious outcomes when progressing to sinus pause or shock. Therefore, drugs to prevent bradycardia during dexmedetomidine infusion may help patients maintain a more stable hemodynamic state. The present study aims to compare the ability of atropine and glycopyrrolate to prevent bradycardia during dexmedetomidine infusion in patients undergoing lower extremity orthopedic surgery with spinal anesthesia.
Aveir DR Real-World Evidence Post-Approval Study
Cardiac PacemakerArrythmia1 moreThe purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.