View clinical trials related to Bradyarrhythmia.
Filter by:The goal of this clinical trial is to evaluate the incidence of bradycardia during laparoscopic cholecystectomy. The main question[s] it aims to answer are: - Does bradycardia really occurs during pneumoperitoneum/laparoscopic surgery? - If the patient get Glycopyrrolate, Does it really prevent pneumoperitoneum/laparoscopic surgery induced bradycardia?
The clinical study is intended to implement and test the collection and analysis of paired ECG data from the HeartWatch and two comparator devices, an Event Recorder and Holter. The HeartWatch is indicated for extended diagnostic evaluation of patients with transient symptoms of possible cardiac origin such as syncope and palpitations, as well as patients at risk for arrhythmias, but without significant symptoms. While the use of the device itself can be managed by both healthcare professionals and patients, interpretation of the collected data for diagnosis is restricted to healthcare professionals, as the data must be loaded and analyzed separately after recording. Patients indicated for extended ambulatory ECG testing will be approached for participation. Subjects will wear the HeartWatch and an Event Recorder for up to 72 hours or the HeartWatch and Holter monitor for up to 48 hours. Subjects will be asked to document their activities (standing, sitting, walking, exercise, or laying down). Event recorder subjects will collect user-triggered and auto-triggered data, while Holter subjects will record diary information on their activities and any relevant symptoms. Adverse events and user preference for one device versus the other being used in that arm will also be collected from all subjects. Paired ECG data from the HeartWatch and comparator devices is expected to be similar in terms of the events documented and the proportion of data that is clinically interpretable.
The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future enhancements in device functionalities.
Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw (active fixation) for initial fixation in the patient´s heart. Both types of electrodes provide similar results in a long-term follow-up and the use of one or the other electrode type in many instances is mainly based on the implanter´s preference. The PACMAN-trial investigates whether the two lead types are associated with different amounts of myocardial micro-damage during implantation.
The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.
The number of patients with implantable pulse generator (IPG) has steadily increased in Japan causing increment in number of in office follow-ups and greater burden on many hospitals. The purpose of this multicenter randomized study is to demonstrate that BIOTRONIK Home Monitoring system reduces office follow-up visits without compromising patient safety.
Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system. Success of a pacing lead implant can be defined considering 3 items: ease of lead implant, lead stability and lead electrical performances. These factors may be related to the physician experience (global implant experience, experience with a given lead), to the implant procedure (lead access, lead position, implant time, scopy time) to the lead (handling and mechanical characteristics) and to the patient (ischemic history). Even though implant success rate is quite high with currently available leads, the weight of the different factors influencing success has never been studied systematically. The objective of the current study is then to define the predictive factors of an implant success with the CapsureFix MRI model 5086. This lead has been selected because it has been available for a short period, so the investigators have a limited experience of it and it has a unique design which makes it conditionally safe in an MRI environment and which may be associated with specific handling characteristics.
The technological progress allowed the development of more and more sophisticated pacemakers, widening the therapeutic indications but also meeting the physiological needs of the patient. This progress led to a more and more complex programming for the physicians. To help them set optimally the pacing parameters, physicians refer to the existing recommendations of learned societies as well as to his expertise. Manufacturers developed also algorithms integrated into pacemakers with the aim of assisting physicians in their programming. TherapyGuide is a function which proposes a programming adapted to the psychopathological state of the patient, with a justification based on experts' consensus, clinical studies as well as on published articles. Physicians have the choice to accept or reject the programming proposed by TherapyGuide. When rejected, there is no means to analyze the modifications brought to the proposed set of parameters. The nature, the frequency and the reasons of these modifications are not thus known. The purpose of this study is to assess the acceptance of the TherapyGuide proposals by physicians and to identify the most frequent type of programming changes they make and their rationale.
Primary Objective: To characterize left ventricular (LV) threshold behavior over time using daily left ventricular capture management (LVCM) measurements. Study Design: This is a multicenter, prospective, non-interventional study with patients receiving their first cardiac resynchronisation therapy-implantable cardioverter defibrillator (CRT-ICD) device. The study design, based on the primary objective, is an observational examination of LV thresholds over time. Daily left ventricular threshold measurements will be collected using the LVCM feature. Up to 150 patients will be enrolled in Canada to evaluate the primary objective at up to 15 study centers. Data will be collected at Baseline, Implant, 12 months post-implant and all regularly scheduled follow-up visits up to 12 months post-implant. Devices: The ConcertoTM CRT-ICD device and future Medtronic CRT-ICD devices containing the LVCM feature will be used in this study.
The study objective is to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international environment.