SW-RCT Implementation of Canadian Syncope Risk Score Based Practice Recommendations
SyncopeSyncope is a common reason for emergency department (ED) presentation. While often benign, some patients have serious and life-threatening underlying causes, both cardiac and non-cardiac, which may or may not be apparent at the time of the initial ED assessment. Identifying which patients will benefit from further investigation, ongoing monitoring and/or hospital admission is essential to reduce both adverse outcomes and high costs. The research team has spent over a decade developing the evidence base for a risk stratification tool directed at optimizing the accuracy of ED decisions: the Canadian Syncope Risk Score (CSRS). This tool is now ready for the final phase of its introduction into clinical practice, namely a robust, multicentre implementation trial of the CSRS-based practice recommendations to demonstrate its real-world effectiveness. These recommendations, if applied, could lead to reduction in hospitalization with only 6% of high-risk patients requiring hospitalization, shorter ED lengths of stay for the 76% of ED syncope patients who are at low risk for 30-day serious outcomes, and more standardized disposition decisions, specifically discharge of 18% of medium-risk patients after appropriate discussion. Hence, the investigators hypothesize that an important reduction in hospitalization and ED disposition time can be achieved by implementing the CSRS-based recommendations with potential improvements in patient safety. The overall objective of this study is to evaluate the effectiveness of the knowledge translation (KT) of the CSRS-based practice recommendations in multiple Canadian EDs using a stepped wedge cluster randomized trial (SW-CRT) on health care efficiency and patient safety.
LBBAP Data Collection Registry
BradycardiaSinus Node Dysfunction4 moreThe purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.
BAsel Syncope EvaLuation (BASEL IX) Study
SyncopeSyncope is a major health problem. In the emergency department (ED), the management of patients with syncope still remains a clinical challenge because underlying diseases and prognosis can be extremely various. Structural heart disease and primary electrical disorders are major risk factors for sudden cardiac death and mortality in patients with syncope. In contrast, patients with reflex syncope and exclusion of structural heart disease have an excellent prognosis. Therefore The investigators test the hypothesis that the use of a meticulous patient history, clinical examination and novel biomarkers can improve the rapid and accurate diagnosis of cardiac syncope in patients presenting to the ED and is able to improve risk stratification regarding adverse outcomes. The prospective multicenter cohort study is designed to enroll 720 patients presenting with transient loss of consciousness within the last 12 hours to the ED. Blood samples for the measurement of novel biomarkers will be obtained at presentation. All patients will be contacted by phone at 6, 12 and 24 months to determine major adverse events (death, resuscitation, recurrence of syncope, hospitalization for syncope).
CSRS Implementation - A Pilot Study
SyncopeSyncope is a common reason for emergency department (ED) presentation. While often benign, some patients have serious and life-threatening underlying causes, both cardiac and non-cardiac, which may or may not be apparent at the time of the initial ED assessment. Identifying which patients will benefit from further investigation, ongoing monitoring and/or hospital admission is essential to reduce both adverse outcomes and the high costs. Our group has spent over a decade developing the evidence base for a risk stratification tool directed at optimizing the accuracy of ED decisions: the Canadian Syncope Risk Score (CSRS). This tool is now ready for the final phase of its introduction into clinical practice, namely a robust, multicentre implementation trial of the CSRS based practice recommendations to demonstrate its real-world effectiveness. Prior to the launch of the large-scale implementation trial, a pilot study to assess primarily the feasibility and secondarily the effectiveness is needed.
Improving Management of Emergency Department Patients With Undifferentiated Syncope: Prospective...
SyncopeAmong Kaiser Permanente Northern California (KPNC) health plan members, age ≥16 years, with recent syncope and presyncope undergoing emergency department (ED) management with a point-of-care clinical decision support (CDS) tool, how well does the Canadian Syncope Risk Score predict 30-day serious outcomes that were not evident during index ED evaluation?
Autonomic Monitoring in Neurocardiogenic Syncope
SyncopeChest Pain1 moreThis is a prospective observational pilot study of suitability of autonomic monitoring via the VU-AMS device for prediction of neurocardiogenic syncope (NCS) in children referred to cardiopulmonary exercise testing (CPET) for a diagnosis of syncope. The study population is children referred for CPET to evaluate for neurocardiogenic syncope. The purpose is to describe autonomic function during rest and exercise and determine the positive predictive value of autonomic function measurements against the gold standard for diagnosis of neurocardiogenic syncope, the CPET. Children presenting for CPET with chest pain or who are status post orthotopic heart transplantation will serve as positive and negative controls respectively.
Validation of PMcardio AI-assisted Clinical Assistant in Primary Care
Cardiovascular DiseasesMedical Device7 moreThis study aimed to analyze and investigate whether the use of the PMcardio clinical assistant leads to a more efficient patient management in primary care and more accessible specialised care compared to usual standards of care and to assess the reliability and safety of the PMcardio smartphone application in the primary care use environment. Additionally, to evaluate time savings and cost saving implications of increased availability of specialised care at the primary care level.
The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study
SyncopeVasovagal1 moreMulticentre, prospective, double blinded, randomized study designed as an intrapatient comparison to evaluate the effects of the Biotronik Closed-loop Stimulation algorithm on prevalence and timing of haemodynamic variations and clinical prodromes induced by head-up tilt test in patients underwent pacemaker implantation for refractory cardioinhibitory vasovagal syncope.
Second Study on Cardio-neuromodulation in Humans
Cardiac DiseaseSyncope3 moreDifferent approaches to cardio-neuroablation (CNA) to treat neurally mediated syncope, sinus node dysfunction, and functional atrioventricular block have been published. Investigators have developed a more limited and specific approach of CNA, called cardio-neuromodulation (CardNM). This treatment is based on a tailored vagolysis of the sinoatrial node through partial ablation of the anterior right ganglionated plexus (ARGP); it is also based on an innovative anatomic strategy. The feasibility of CardNM has already been tested in our center in a limited first study in humans (CardNMH1), with a favorable outcome for the patients involved. The results of CardNMH1 have been submitted for publication. The purpose of this second study of CardNM in humans (CardNMH2) is to collect more procedural and clinical data in well-defined patient groups.
Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope
Vasovagal SyncopeThe main purpose is to prevent syncope in patients with recurrent syncopal episodes caused by malignant vasovagal faints and bradycardia. Patients are treated by a special pacemaker (closed loop stimulation [CLS]) which can potentially identify an incipient attack and prevent syncope by pacing.