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553 active trials for Atrial Fibrillation

Effect of Venous Cannulation on the Incidence of Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass

Context Atrial fibrillation is the most frequent arrhythmia following coronary artery bypass grafting. POAF is associated with worse outcomes following CABG. In addition, recurrence of AF is associated with longer hospital stay and higher rate of neurological and renal complications compared to a single episode of AF Objective To estimate the proportion of eligible people who are willing to participate, number of participants who drop out of the trial and use the results of this study to inform a larger study. Study Design: Pilot randomized controlled trial. Patients will be blinded to the intervention. Participants: The study population will include 40 patients. Patients admitted to the Jewish General Hospital for elective coronary artery bypass grafting from May 2021 will be included in the study. Patients will be included if they were in sinus rhythm with a HR ?50 bpm, undergoing on-pump coronary artery bypass grafting and hemodynamically stable. Patients will be excluded from the study if they meet any of the following criteria: Second or third degree heart block, LVEF <35%, left atrial volume index ?42 ml/m2, right atrial volume index > 47 ml/m2, any degree of tricuspid regurgitation, any degree of right ventricular dysfunction, emergency or minimally invasive operation, concurrent valve operation, history of atrial fibrillation or previous cardiac surgery Study Interventions and Measures Patients will be randomly assigned to one of two treatment groups according to the venous cannulation technique used during surgery. Group A will undergo cavoatrial cannulation with a 2-stage venous cannula. Group B will undergo bicaval cannulation with snares. Similar surgical methods will be used in all treatment groups . The primary endpoint will be defined as any episode of atrial fibrillation in any participant lasting >5 minutes in duration or any episode leading to hemodynamic compromise (SBP<90 mmHg) or causing symptoms (angina or dyspnea). Atrial fibrillation will be diagnosed using telemetry and a 12-lead ECG. Patients will be followed up in 1 month with a 12-lead ECG to determine their rhythm. The secondary endpoints are the development of RV dysfunction, tricuspid regurgitation and any increase in left atrial volume index as detected by post-operative transthoracic echocardiography.

Start: May 2021
What is the Optimal Antithrombotic Strategy in Patients Presenting With Acute Coronary Syndrome Having Atrial Fibrillation With Indication for Anticoagulants?

The optimal antithrombotic management in patients with coronary artery disease (CAD) and concomitant atrial fibrillation (AF) is unknown. Patients with AF are treated with oral anticoagulation (OAC) to prevent ischemic stroke and systemic embolism and patients with acute coronary syndrome (ACS) or those who undergo percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), i.e. aspirin plus P2Y12 inhibitor (clopidogrel), to prevent stent thrombosis (ST) and myocardial infarction (MI). Patients with AF undergoing PCI were traditionally treated with triple antithrombotic therapy (TAT, i.e. oral anticoagulation (OAC) plus aspirin and P2Y12 inhibitor) to prevent ischemic complications. However, TAT doubles or even triples the risk of major bleeding complications. More recently, several clinical studies demonstrated that omitting aspirin, a strategy known as dual antithrombotic therapy (DAT) is safer compared to TAT with comparable efficacy. However, pooled evidence from recent meta-analyses suggests that patients treated with DAT are at increased risk of myocardial infarction (MI), stent thrombosis (ST) and even cardiovascular (CV) death. Insights from the AUGUSTUS trial showed that aspirin added to OAC and clopidogrel for 30 days, but not thereafter, resulted in fewer severe ischemic events. This finding emphasizes the relevance of early aspirin administration on ischemic benefit, also reflected in the current ESC guideline. However, because we consider the bleeding risk of TAT unacceptably high, we propose to use a short course of DAPT (drop the OAC for 1 month). There is evidence from the BRIDGE study that a short period of omitting OAC is safe in patients with AF. In this study, these patients are treated with DAPT that also prevents stroke, albeit not as effective as OAC. Thus, by omitting OAC in the first month, we make room for aspirin use for optimal prevention of myocardial infarction or stent thrombosis in the first month after ACS or PCI. The WOEST 3 trial is a multicentre, open-label, randomised controlled trial to investigate the safety and efficacy of one month DAPT compared to standard therapy consisting of OAC and P2Y12 inhibitor combined with aspirin up to 30 days. We hypothesise that the use of short course DAPT is superior in bleeding and, secondary, non-inferior in preventing ischemic events. The primary endpoint is clinically relevant bleeding (according to the International Society of Thrombosis and Haemostasis definition) after one month. Secondary endpoints include a composite of CV death, MI, ischemic stroke, ST, and systemic embolism after one month, and one year follow-up.

Start: July 2022
Prevention of Atrial Fibrillation by Low-dose Landiolol Administration After Cardiac Surgery

Postoperative atrial fibrillation (POAF) is a common complication that occurs in 30-50% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. During the perioperative period, the discontinuation of beta-blocker treatment is known to be a risk factor for developing POAF in patient undergoing cardiac surgery. Early beta-blocker reintroduction is associated with lower incidence of POAF. Unfortunately, side effects of currently available beta-blockers (including esmolol), such as low blood pressure and excessive bradycardia and/or their extended duration of action, limit their use in the post-operative period especially for prevention. Landiolol, an ultra-short acting injectable beta-blocker, offers the advantage of significantly limiting low blood pressure events while increasing therapeutic efficacy in the treatment of POAF in cardiac and non-cardiac surgery. Landiolol, when used at low dose in the postoperative period, has been showed to reduce the incidence of POAF with no increased incidence of side effect as compared to standard of care. The limitation is that these promising data come from single center studies with limited samples and conducted exclusively in Japanese population. If landiolol is approved for use in the treatment of atrial fibrillation in non-Asian patients, there are no data on the prevention of POAF in cardiac surgery. The objective of this multicenter, double-blind, randomized, placebo- controlled phase III trial is to confirm that landiolol postoperative infusion is associated with lower incidence of POAF without excess of adverse events as compared to standard of care in a non-Asian population after cardiac surgery with sternotomy.

Start: January 2021
High Density Scar Guided Atrial Fibrillation Mapping

HD SAGA: There is increasing evidence that having AF is associated with some scarring of the upper chamber of the heart, the left atrium. There is also evidence that the amount of scarring can predict ablation success rates. Recently, rapid ultra high density mapping equipment has become available and this has the capability of defining the electrical scar in the atrium in detail. The equipment used to do this is standard approved equipment for the procedure but its use for making scar maps has not been fully assessed. In the mapping phase of the study therefore, the aim will be to collect high density scar maps in AF and normal rhythm to see how they compare. Maps will be collected in different ways to see if that changes their accuracy. The study will also assess if the values previously suggested as representing scar with lower density mapping systems are still appropriate where high density mapping equipment is used. The results from this study will help to improve the understanding of scar in the atrium and help demonstrate the most efficient way to collect scar information using this high density mapping equipment. In the future, clinicians may be able to use these very detailed scar maps to tailor and refine the way they ablate patients with AF, though the focus of the current study is just on collecting the scar information. While identifying areas requiring ablation is important to an ablation procedure, the other important aspect is the efficacy of ablation. Until now, we have been reliant on assessing our inputs into an ablation (such as the level of contact and the power delivered) but have been limited in the assessment of the output of an ablation in terms of lesion characteristics. New ablation catheter technology is now available which can assess the localised impedance drop with ablation. This is likely a better surrogate for lesion parameters than what we have previously had available and merits further study. Based on such study, we may be able to define targets for ablation which would help to guide future ablations. HD SAGA S: Approval amendment March 2021 In addition to the above, using new catheter technology incorporating contact force into the assessment of ablation lesion efficacy. HD SAGA H: Approval amendment March 2021 Using new mapping catheter (HD Grid) and algorithms (HD Wave) to compare scar maps between AF and SR and pre-establish pulmonary vein isolation lines.

Start: August 2019