Mode Selection Trial in Sinus Node Dysfunction (MOST)
ArrhythmiaCardiovascular Diseases4 moreTo determine if dual chamber rate-modulated pacing (DDDR) in patients with sick sinus syndrome is superior to single chamber pacing (VVIR) with respect to subsequent frequency of adverse clinical events such as stroke, quality of life and function, and cost effectiveness.
Safety and Performance Study of the INGEVITY Lead
BradycardiaSinus Node DysfunctionThe objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
ImageReady(TM) MR Conditional Pacing System Clinical Study
BradycardiaSinus Node DysfunctionThe objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with the Conditions of Use included in the Boston Scientific MRI Technical Guide
AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals
Atrioventricular BlockSick Sinus Syndrome2 moreThis is a randomized, prospective clinical trial to determine the effects of two different pacemaker atrioventricular delay (AV delay) settings on heart function in patients with dual chamber pacemakers implanted for symptomatic bradycardia with long PR intervals (delayed conduction between upper and lower chambers of the heart). The study will compare a long, fixed AV delay (standard) with an optimized AV delay for each individual using echocardiography (experimental).
Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
Heart BlockSick Sinus Syndrome2 moreThe study aims to use cardiac MRI scans and analysis techniques to evaluate differences in cardiac function after 12 months of pacing in patients with pacing leads placed in different positions within the right ventricle (apically or septally).
Ingenio Device Algorithm Study
Sinus Node DiseaseAV Block1 moreThe purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
Ventricular Pace Suppression Versus Intrinsic Rhythm Support Study
Sick Sinus SyndromeThe objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: Intrinsic Rhythm Support Plus (IRSplus) and Ventricular Pace Suppression (VpS). The study will compare ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted with a pacemaker for Sick Sinus Syndrome.
Reducing Atrial Pacing Rate to Reduce Atrial Fibrillation in Patients With Sick Sinus Syndrome....
Sinus Node DiseaseAtrial FibrillationAtrial fibrillation (AF) is prevalent in patients with sick sinus syndrome (SSS) and associated with an increased risk of stroke and death. Within the first two years after pacemaker implantation almost half of the patients are diagnosed with AF. Studies have indicated that an increased amount of stimulation from the pacemaker in the atria is associated with an increased amount of AF. The aim of the present study is to test the hypothesis that a reduction of stimulation from the pacemaker in the atria, and reducing the minimal heart rate, increases the time to AF.
Right Ventricular Outflow Tract Study
Sinus-node DysfunctionThis is a prospective, randomized, double blinded, multi-center, controlled study to evaluate the clinical impact at 18 months after DDD implantation of alternative pacing site (RVOTs and RVA) and the different conduction path (RVOTs and AV node) on cardiac dysfunction prevention.
Austria Study - Analysis of Difference Between Active and Passive Fixation Leads
BradycardiaHeart Block1 moreIn this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated. In addition the influence of the stimulation location by type of lead on QRS width, ejection fraction and NYHA class will be evaluated using and electrocardiogram and echocardiogram.