NOACs for Atrial Tachyarrhythmias in Congenital Heart Disease
Congenital Heart DefectsAtrial Fibrillation1 moreRationale: Adult patients with congenital heart disease (CHD) with atrial tachyarrhythmias need to be anticoagulated. It is not known whether non-vitamin K antagonist oral anticoagulants (NOAC) in this patient group are efficient and safe. Aim: The purpose of the NOTE registry is to evaluate the efficacy and safety of NOACs for thromboembolic prevention in atrial tachyarrhythmias in adult patients with congenital heart disease (CHD). Methods: In this multicenter prospective registry adult CHD patients with atrial tachyarrhythmias on NOACs (switch from VKA or new on anticoagulants) will be followed for a minimum of two years. Primary efficacy endpoints are defined as thromboembolism, i.e. the composite of ischemic stroke, systemic and pulmonary embolism and intracardiac thrombosis, and as the composite of stroke and systemic embolism. Primary safety endpoint is defined as major bleeding according to the ISTH criteria. Secondary endpoints include each thromboembolic or bleeding event analysed separately, all-cause mortality, therapy adherence, quality of life, risk assessment of stroke and evaluation of natural history of atrial tachyarrhythmia in adult CHD patients. Primary endpoint assessment will be performed with a per protocol analysis, and demonstrated as Kaplan Meyer estimates of event free survival and event rates per year.
Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients...
Percutaneous Coronary InterventionPatients undergoing percutaneous coronary intervention (PCI) with stent implantation and requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are required to receive triple antithrombotic therapy . This triple therapy includes dual antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC). Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the coagulation cascade have demonstrated non inferiority compared to VKA to prevent thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc >1 . Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA. Overall they seem to result in a lower bleeding rate compared to VKA in association with antiplatelet agents. Recently European guidelines regarding patients requiring chronic anticoagulant therapy and undergoing coronary stent implantation have been updated. However they are based on an expert consensus because of the scarce data available. These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5 . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines suggest that a sole antiplatelet agent could be used in addition to anticoagulation following the WOEST study . In the recently published ESC guidelines on the management of atrial fibrillation, despite the lack of new data, the expert advocate triple therapy followed by dual antiplatelet therapy in most patients for 12 months. The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban 15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar efficacy .
Non-invasive Blood Pressure and Cardiac Output Measurement by Using Applanation Tonometry
Atrial FibrillationLeft Ventricular Failure2 moreTo evaluate and to validate accuracy, precision and trending ability of blood pressure and cardiac output measurement by applanation tonometry in cardiological patients having: atrial fibrillation severe impaired leftventricular function severe aortic valve stenosis patients having left ventricular assist device Experimental measurement: continuous blood pressure measurement and cardiac output measurement is performed by the T-Line 200 pro device (Tensys Medical Inc., San Diego, USA) Control measurement: gold-standard continuous blood pressure measurement is performed by invasive blood pressure measurement by arterial cannulation and cardiac output reference is assessed by transcardiopulmonary thermodilution
Impact of the Pulmonary Vein Isolation on Exercise Capacity in Patients With Chronic Atrial Fibrillation...
Chronic Atrial FibrillationThis study would assess the impact of radio-frequency catheter ablation on exercise capacity and quality of life in long-standing persistent atrial fibrillation (LSP-AF) patients
A CALIBER Study: Risk Factors for Stroke, Heart Failure, and Myocardial Infarction in Atrial Fibrillation...
Atrial FibrillationHeart Failure2 moreWe aim to investigate the prognosis of patients diagnosed with AF, particularly in relation to the development of subsequent stroke, heart failure, and myocardial infarction. We will explore the relationship between these outcomes and a range of risk factors.
Cardioversion of Atrial Fibrillation Accompanied by Chronic Heart Faliure
Chronic Heart FailureThe purpose of this study is to explore the efficacy of low energy cardioversion on atrial fibrillation accompanied with chronic heart failure treated with HTEA or usual medicine.
Evaluation of Effectiveness and Safety of Xa Inhibitor for the Prevention of Stroke And Systemic...
Non-valvular Atrial FibrillationThe efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.
Atrial Fibrillation and the Risk for Neurological Complications
Atrial FibrillationB8: Atrial fibrillation and the risk of neurological complications Twenty-five thousand acute strokes are caused by atrial fibrillation every year. But even more frequent than symptomatic strokes are silent infarctions of the brain. Silent strokes remain undetected in most cases, but cumulate over time and progressively impair cognition. The impact of atrial fibrillation on subacute brain infarctions is not yet known. Moreover, it has not been elucidated so far how effective different therapeutic strategies in the treatment of atrial fibrillation prevent cognitive impairment. Thus, this study aims at evaluating the influence of different types of atrial fibrillation on silent strokes and the related impairment in cognitive functions. Other risk factors and cardiovascular diseases that are known to provoke the development of strokes will be assessed as well. So, it will be possible to isolate the contribution of atrial fibrillation to silent strokes and related cognitive impairment in segregation to other relevant factors. AF patients and controls will be examined twice in two years in order to evaluate the role of atrial fibrillation and differential therapeutic interventions with regard to the progression of silent strokes and cognitive impairment in a within subject-design.
Artificial Intelligence Use for the Detection of Atrial Fibrillation Drivers
FibrillationAtrial1 morepilot clinical study, multicenter, prospective, open, nonrandomized
AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational
Atrial FibrillationLeft Atrial Appendage1 moreThe ACP device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study.