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.
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.
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)
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.
This is a an investigator-initial, multicenter, open-label, randomized, parallel-group comparative study to evaluate the effect on the incidence of AF and pacemaker dependence in SSS patients receiving physiological atrial-based pacing alone or adding losartan 100mg to physiological atrial-based pacing treatment. The duration of the study will be approximately 13 months, comprising 4-week pre-study period, and 12-month treatment period.
The objective of this trial is to show the therapeutic efficacy of the preventive pacing therapies of the Selection 9000 and Vitatron T70 DR pacemakers, dedicated to handle atrial fibrillation (AF). Two new algorithms (post-AF response and ventricular rate stabilization [VRS]) will be assessed in a combined pathway, compared to a control group. The efficacy of the overall available therapies to prevent AF and its symptoms will then be assessed also.
The purpose of this study is to determine the incidence of atrial fibrillation and heart failure in patients with pacemaker therapy with different pacing modes (AAI, DDD, and a novel algorithm to minimize ventricular pacing).