Validation of the NTX Wireless Patient Monitoring System
DesaturationBradycardia3 moreReduction in time to detection of Clinically Significant events Reduction of time to Intervention during Clinically Significant events Reduction in the number of admissions to Intensive Care
Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II
Standard Bradycardia Pacing IndicationThe purpose of this study is to characterize the utilization of diagnostics capabilities in St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing indication.
Verification of Prediction Algorithm
Shortness of Breath EpisodeTachycardia2 moreProspective observational clinical study to verify an algorithm used to predict cardiopulmonary events in patients presenting to the emergency department.
Physiologic Pacing Registry
BradycardiaSinus Node Dysfunction5 moreThe Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures prior to physiologic pacing device implants based on the clinical site's routine care.
Predictive Value of Heart Rate Variability on Cardiorespiratory Events
Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)The aim of this study are to investigate whether heart rate variability (HRV) parameters derived from nonlinear time series analysis at five different time points have prognostic utility for assessing the risk of postimmunisation AOP in very preterm/very low birth weight infants immunised in the hospital.
IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
Sinus BradycardiaSinus Node Disease1 moreThe purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.
Complications Following Pacemaker Implantation
BradycardiaThis study examines possible risk factors with regard to complications following pacemaker implantation.
MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY
ArrhythmiaBradycardiaThe primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from the System Longevity Study (SLS).
NTX Wireless Patient Monitoring System
DesaturationBradycardia3 moreDetermine the accuracy of the NTX wireless monitoring system alerts Evaluate patient compliance with wearing device Determine false alarm rates
INGEVITY™ Observational Trial
BradycardiaThe objectives of this registry are to Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events Gather data on actual number of MRI scans performed in the patient cohort implanted with an ImageReady system including information about scanned body parts. Collect physician feedback on lead handling with the INGEVITY lead in a real-life, market-released standard of care environment using devices on intended purpose and which are authorized to bear the CE (Communauté Européenne) marking / are approved for use in the applicable area of participating centers. No additional invasive or other burdensome examinations are to be carried out other than the ones conducted by the centers per their general standard of care.