AcQBlate Force Confirmatory Study for Atrial Arrhythmias
Atrial ArrhythmiasAcQBlate Force Confirmatory Study for Atrial Arrhythmias (AcQBlate Force-PRA)
A Digital Flu Intervention for People With Cardiovascular Conditions
Cardiovascular DiseasesAtrial Fibrillation8 moreA 6-month prospective, digital randomized controlled trial targeting approximately 49,000 individuals to evaluate the effectiveness of an influenza vaccination intervention during influenza season for people with cardiovascular conditions
Transcutaneous Electrical Stimulation & Sinoatrial Node Function
Electricity; EffectsHeart ArrhythmiaTranscutaneous electrical stimulation (TES) is used in clinical practice to diagnose or treat a diverse range of medical conditions for over a century. Although the benefits of TES are well known, its potential side effects on the heart have not been convincingly clarified. This study will test whether TES has any effect on the sinoatrial node (SAN).
An Evaluation of the Safety and Performance of the CathVision Cube® System
Cardiac ArrhythmiaThe primary objective is to evaluate the safety and technical performance of the CathVision Cube® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.
NIPS to Identify High-risk Patients With ICD
Malignant ArrhythmiaImplantable cardioverter-defibrillator (ICD) is a widely used and effective therapy which reduces the risk of cardiac death in many cardiac diseases, both implanted for secondary and primary prevention. It is known that recurrent arrhythmias and ICD discharges have adverse prognostic significance. Parameters that would identify patients who are at increased risk of arrhythmias and appropriate ICD interventions would be of clinical value. The aim of the study is to evaluate the usefulness of non-invasive programmed stimulation (NIPS) in determining the likelihood of life-threatening arrhythmic events in patients with ICD.
AutoMatic disPERsion Tagging Function Preliminary Evaluation
Atrial FibrillationAtrial Tachycardia1 moreInterventional, prospective, non-randomized, single-center, non-controlled clinical investigation as part of the premarket clinical evaluation of VX1+ medical device, aiming to verify that VX1+ in bidirectional configuration with auto-tagging function is both ergonomic and reliable for dispersed electrograms detection and automatic tagging on 3D-map in real-time.
Effects of Marine n-3 Fatty Acids on Heart Rate Variability and Arrhythmias in Patients Receiving...
Kidney Failure ChronicArrhythmias CardiacBackground: End Stage Renal Disease (ESRD) patients have an extremely high mortality and the leading cause of death is cardiovascular disease which accounts for 50% of all deaths. It is estimated that about one third is due to arrhythmias. Previous studies reveal a higher risk of various arrhythmias in dialysis patients but the prevalence is uncertain. Atrial fibrillation is the most common arrhythmia among patients with ESRD. The arrhythmia is often asymptomatic, but the risk of stroke increases dramatically and the annual mortality doubles. Autonomic cardiac dysfunction is often seen in patients with ESRD, and this is expressed by attenuated Heart Rate Variability (HRV) which is a measure of the variation in the time interval between heart beats. Attenuated 24 hours HRV is associated with an increased risk of sudden cardiac death in the general population and among patients with ESRD. N-3 polyunsaturated fatty acids (PUFAs) in fish or fish oil supplements have been shown to increase HRV and reduce the risk of various ventricular and supraventricular arrhythmias in some but not all studies, but this effect has only been sparsely investigated in the high risk patients with ESRD, who has a very low intake of n-3 PUFAs. Objective: The purpose of this study is to investigate the effects of n-3 PUFA supplementation on HRV and arrhythmias in dialysis patients. Hypothesis: n-3 PUFA supplementation increases 24 hours HRV in dialysis patients. n-3 PUFA supplementation reduces the level of Supraventricular tachycardia, premature atrial complexes (PACs) and premature ventricular complexes (PVCs) in chronic dialysis patients. Design: Randomized double-blind, placebo controlled trial Study participants: 140 dialysis patients at Aalborg University Hospital and Vendsyssel Hospital, Hjørring in Denmark. Inclusion time: Summer 2014 to Fall 2015 Methods: The patients are allocated to 3 months treatment with supplements of 2 g n-3 PUFAs or placebo (olive oil). The following data are registered at baseline and after 3 months treatment: Demographics and medical history, Standard ECG-12, blood pressure, blood samples, 48 hours ambulatory ECG Holter recordings, Intake of n-3 PUFAs (assessed by questionnaires and blood measurements). Perspective: A positive result of this study might make it possible to achieve a reduction in arrhythmias and mortality in these high risk patients by a cheap and well tolerated nutritional supplement.
Diagnosis of Arrhythmias in Syncope by Pocket-ECG III® or Conventional Holter
SyncopeThe purpose of this study is to determine whether continuous cardiac telemetry with the Pocket-ECG III® system is more useful than conventional Holter to find out the cause of syncope
The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection
ArrhythmiaThe Master Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG. The electrodes are dry, textile ECG electrodes. The garment is designed to position the electrodes in the appropriate anatomical locations, without any special guidance. The dry electrodes are made from unique yarns with silver embedded into the garment using a proprietary technique developed by HealthWatch (HW)that obviates the need for skin preparation or the application of fluids. The garment can be connected to any standard ECG device available in the hospitals. The purpose of this study is to evaluate the safety and effectiveness of the Master Caution Garment for continuous monitoring of ECG signal compared to standard gel electrodes. The following endpoints will be evaluated in subjects participating in the study: Primary: Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes using standard ECG devices. Secondary: Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes when event is detected by the ECG devices.
Prevention of Arrhythmia Device Infection Trial (PADIT)
ArrhythmiaThe goal of the study is to compare whether a center-wide policy of incremental antibiotic therapy will reduce CIED infection rate compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. All antibiotics used are approved for use and readily available.