View clinical trials related to Sick Sinus Syndrome.
Filter by:This study is a long-term, prospective, and controlled evaluation of the mechanical dyssynchrony induced by right ventricular apical pacing, both in acute (spontaneous and stimulated) and chronic (12 and 24 months); the study also evaluates the benefit of an alternative pacing site through measures of dyssynchrony in acute and chronic.
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
The aim of this study is to evaluate the effect of minimizing right ventricular pacing in dual-chamber pacemaker patients with sinus node disease (SND) and first degree atrioventricular block (AVIB)on exercise capacity, quality of life and other heart failure measures.
Cardiac pacing is the only effective treatment for symptomatic bradycardia. The right ventricular apex (RVA) has become the most frequently used ventricular pacing site. However, RVA pacing has been shown to cause left ventricular (LV) dyssynchrony wich can lead to LV dysfunction and development of heart failure. Recent studies in animals have demonstrated that pacing at the LV septum induces significantly less ventricular dyssynchrony than RVA pacing and is able to improve LV function to a similar degree as biventricular (BiV) pacing. In addition it was shown that a LV septum lead can be placed permanently by driving a lead with extended helix from the RV side through the inter-ventricular septum into the LV endocardial layer. This was shown to be a feasible and safe procedure and lead stability was shown during four months of follow-up in otherwise healthy and active canines. LV septum pacing may therefore be a good treatment alternative in patients with symptomatic bradycardia, as well as patients with an indication for cardiac resynchronization therapy (CRT). The purpose of this study is to translate the findings from preclinical studies to the clinical situation by investigating the feasibility, long-term lead stability and safety of LV septum pacing by transvenous approach through the inter-ventricular septum in patients.
The 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.
Background: - Potential negative effects of pacing in the RV-apex are well documented - However, study results comparing septal / RVOT-pacing versus RV-apical pacing controversial. - The optimal pacing mode in SSS (DDDR versus AAIR) is unclear, as the DDD (R) mode with an AV delay ≤ 220 ms should be the preferred pacing mode, according to the DANPACE trial [DANPACE, ESC 2010, Stockholm]. Aim: - to evaluate chronic effects of proven right ventricular septal compared to minimized right ventricular septal pacing in patients with SSS Inclusion criterion: -Pacemaker indication according to current guidelines: sick sinus syndrome (SSS) Exclusion criteria: - Life expectancy < 2 years - Age <18 years - Noncompliance with regard to participation in the study - Pregnancy - AV block ° 2 and higher - Permanent atrial fibrillation - Heart failure NYHA III and IV, reduced LV-EF <40% - ICD indication - Acute coronary syndrome. PCI or CABG <3 months - Heart transplant - Placement of septal RV electrode is not possible Study design: - Prospective, monocentric, randomized, double-blinded - Run-in phase: for weeks AAI [R]-DDD [R] - Randomization: two groups A) septal right ventricular chamber pacing: mode DDD [R] versus B) Reduction of unnecessary ventricular pacing: AAI [R]-DDD [R]. - FU: 6 and 12-months Primary endpoints: -LV ejection fraction and end-systolic LV volume after 12 months. Secondary endpoints: -LV end-diastolic volume, TAPSE, parameters of dyssynchrony (SPWMD, LV-PEP, IVMD), AF-burden, % ventricular pacing, CPX: peak oxygen consumption (peak VO2), VO2 AT, VO2/HR, VE/VCO2 slope; QoL scores (SF-36) after 12 months. Statistics/sample size estimation: In order to detect a difference in LVEF of 5% and for LV-ESV of 5 mL between the 2 groups after 12 months: - 90% power/alpha 5%: 84 patients per group - 80% power/alpha 5%: 63 patients per group - 10% for compensation of drop-outs / patients lost of follow-up. Two-sided 5% type 1 error Analysis intention-to-treat and based on the finally programmed pacing mode. Material - PG: market released dual chamber pacemakers with the ability to pace AAI(R) -DDD(R) - pacing leads: market-released standard active electrodes - RV electrode: septal verified under multi-level screening (RAO/LAO) and ECG (LBBB narrow <150 ms / inferior axis)
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
Evidence has been documented for the close relationship between the arrhythmia pathogenesis and the gene expression in renin-angiotensin system. However, it remains unclear for involvement of RAS in the pathogenesis of non-familial sick sinus syndrome. The researchers thus investigated the possible relationship between non-familial sick sinus syndrome and the polymorphism and haplotype of the AGT promoter.
In this study, the investigators will examine whether left ventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia with high risk for development of pacing-induced heart failure.
This 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.