Apple Watch-led Surveillance of AF Recurrence After Catheter Ablation
Atrial FibrillationAtrial fibrillation (AF) is a heart rhythm disorder associated with debillitating symptoms, psychological distress and heart failure. It can also significantly increase an individuals stroke risk. Catheter ablation (CA) for AF is the most effective way to restore normal heart rhythm. However, AF can recur in up to 50% of patients after their first CA procedure and a second 'top-up' procedure may be needed to maximise effect. Early detection of recurrences can enable planning and treatment and repeat CA procedures. Post-CA follow-up strategies rely on episodic rhythm monitoring (Holter monitor tests) that usually last between 1 and 7 days. However, AF recurrences can be intermittent and may not occur during these short monitoring episodes. A greater duration of monitoring has been shown to yield greater detection of AF recurrences. Relying on symptoms alone to detect recurrence is also sub-optimal. AF recurrences can also be insidious. Similar symptoms may be reported from ectopy, atrial tachycardias or atrial flutter. These may require different management approaches, necessitating rhythm characterisation before considering a repeat CA. The Apple Watch (AW) is a wristwatch that is able to monitor a wearer's heart rate and rhythm regularity as well as facilitating an immediate, real-time single-lead ECG recording. This non-invasive device that can be purchased over- the-counter has demonstrated feasibility in detecting AF and may offer a potential non-invasive, alternative long-term rhythm surveillance strategy to diagnose AF in these patients. The investigators propose a single-centre, randomised controlled study to compare the standard follow-up strategy after index AF CA versus one supplemented with an AW-led prolonged monitoring strategy to determine if the latter will improve the expediency and rate of AF recurrence detection. Whether this will lead to improved downstream decision-making, reduction in symptomatic events and a lower prevalence of AF in the longer term will also be studied.
Risk-Based Screening for the Evaluation of Atrial Fibrillation Trial
Atrial Fibrillation and FlutterTo determine whether a risk-based screening programme for occult paroxysmal atrial fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of 3 or greater, increases the detection of new atrial fibrillation/flutter. To determine whether a risk-based screening programme for occult paroxysmal atrial fibrillation, involving extended cardiac monitoring in adults with CHA2DS2-VASc score of 3 or greater, is cost-effective. To determine the sensitivity, specificity, positive predictive value and negative predictive values of self-monitoring of pulse in adults for detection of atrial fibrillation. To determine the cost, cost effectiveness, and budget impact of a risk-based screening programme for occult paroxysmal atrial fibrillation, relative to a control of usual care in general practice.
Assessment of the Link Between Monomeric Functional Form Plasma Level of Vasostatin-1 and Occurrence...
Atrial FibrillationShockAtrial fibrillation (AF) is a cardiac rhythm disorder particularly common in intensive care patients. Some meta-analyzes report a prevalence of new onset AF ranging from 4.5% to 29.5% in polyvalent intensive care. In our department, a recent month-long survey showed that more than 30% of the patients who were unhealthy on admission suffer from an episode of new onset AF during their stay. The occurrence of AF in intensive care has a pejorative effect on the patient's outcome, and this through two factors. On the one hand, the decreasing of cardiac output by degradation of the ventricular filling in diastole time, on the other hand the FA is responsible for an over-risk of ischemic stroke. In fact, it has been shown that the occurrence of new onset AF in intensive care is associated with a higher level of severity and a higher mortality. It is also important to underline the medico-economic impact of this rhythmic disorder as complication of shock due to the frequent prescription of various anti-arrhythmic or anticoagulant medication. Various factors have been mentioned to explain the frequent occurrence of AF in shocked patients. The shock state, whatever its origin, is characterized by the occurrence of a systemic inflammatory response syndrome in which is observed a particularly important releasing of stress hormones and endogenous catecholamines involved in the occurrence of a rapid multi-organ failure without treatment. Systemic humoral elements are possibly involved in the occurrence of new onset AF, such as high level of inflammation that characterizes shock states. In addition, physiological factors such as hypoxia, hypovolemia, hyperthermia or ionic disorders are also implicated, but their non-systemic association with intensive care new onset FA suggests that humoral factors may play an important and independent role. Among these humoral factors, the proteins of chromogranin family particularly Vasostatin-I (VS-I) seem possibly involved in the genesis of AF in the aggressed intensive care patients. Several studies have highlighted the beneficial regulatory role of VS-I on the cardiovascular system, particularly in a study on a canine model Stavrakis and al. have shown the VS-I protective role on the FA occurrence. However, as has been demonstrated in a prospective study in intensive care, the rates of circulating VS-I were significantly higher in the most severe patients and those whose prognosis was the most pejorative, thus not supporting the thesis of the protective effect of VS-I. An explanation exists for this discrepancy: VS-I is present in two distinct forms in the circulating blood. In vitro work carried out within the U1121 INSERM team with has made it possible to highlight the coexistence of two forms of VS-1: an aggregated "inactive" form and an "active" disaggregated form. In our hypothesis, the inactive aggregated form would be predominant during the states of acute pathological aggressions such as the shock and thus would not exert the anti arrhythmic and cardio protector expected functions. The first aim of our study is therefore to confirm that the onset of new onset FA during the shock state is associated with a significant decrease in the VS-I plasma level in its monomeric form called "active", even when high levels of total VS-1 are detected by ELISA in the plasma of patients. Our project is a pilot and unpublished translational work. The link between VS-I and new onset AF in intensive care severe patients has never been studied in vivo, and the recent work of the associated INSERM team provides advances in understanding the function of VS-I over time shock conditions. Nevertheless, our experimental hypothesis require confirmation in humans. A better understanding of the factors influencing the occurrence of cardiac arrhythmias in intensive care patients is a major ambition as it would be a step forward in the development of a preventive strategy or new treatment for the benefit of patients.
Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation
Atrial FibrillationThe goal of this single center, investigator initiated, open label prospective randomized controlled trial is to compare the efficacy of a single 200J RBW shock and a single 360J BTE shock. The secondary objective of the study is to compare the frequency of adverse events after one or two 200J RBW or 360J BTE shocks
PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation
Atrial FibrillationIntracerebral HemorrhageAtrial fibrillation (AF) is the most common form of irregular heart rhythm. In people with AF, blood clots often form in the heart, which can travel to the brain. Blockage of brain arteries by these clots is a major cause of stroke. This type of stroke is called an ischaemic stroke and approximately 15% of all ischaemic strokes are caused by AF. People with AF are often prescribed a medication called an anticoagulant, which makes it less likely for blood clots to form and thus can prevent ischaemic strokes. However, anticoagulants also increase the risk of bleeding, so they are not suitable for everyone. Some people who have AF have had a different type of stroke which is caused by bleeding in the brain, an intracerebral haemorrhage (ICH). These people are at increased risk of suffering both an ischaemic stroke (due to AF) and another ICH. It is not known whether it is best for these people to take an anticoagulant medication or not, as previous research studies did not include this group of people. PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF) is a research study on the best stroke prevention in people with atrial fibrillation (AF) who have recently had a bleeding in their brain, (ICH). This is a trial where half of the participants will take an anticoagulant medication, preventing blood clot formation, and half will not receive an anticoagulant. The direct oral anticoagulants (DOACs) that will be used in this trial are all licenced for use in the United Kingdom and within the European Union (EU) to prevent strokes in people with AF. However, the current licence does not extend to use with people who have had an ICH because it has not been tested in this group with a randomised controlled trial. DOACs will be tested in ICH survivors with AF because previous research trials have shown that people are up to 50% less likely to have bleeding complications in the brain with DOACs than with Warfarin (another commonly used anticoagulant). The aim of PRESTIGE-AF is to answer the question of whether people with ICH and AF should take an anticoagulant medication or if it is better for them to avoid it.
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative AF After...
StrokeAtrial FibrillationMultinational, investigator-initiated study of oral anticoagulation versus no anticoagulation for the prevention of stroke and other adverse cardiovascular events in patients with transient perioperative atrial fibrillation after noncardiac surgery and additional stroke risk factors.
Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation...
Upper Gastrointestinal BleedingCurrent clinical society guidelines and statements are non-specific and relatively open-ended regarding the optimal timing to restart non-warfarin oral anticoagulant (NOAC) after gastrointestinal bleeding (GIB) in patients with atrial fibrillation (AF) who require the prophylactic medication for stroke prevention. These patients are at increased risk for devastating future thromboembolic events including stroke if NOAC is not resumed promptly, whilst premature resumption of anticoagulants can result in recurrent GIB, haemorrhage, anaemia, myocardial ischaemia and infarction in those with ischaemic heart disease, and even death. However, the question as to how early a NOAC can be safely restarted after acute GIB has not been previously answered, and there remains an important knowledge gap.
Positron Emission Tomography (PET) Imaging of Thrombosis
Atrial FibrillationCOVID-192 moreThe purpose of the study is to evaluate a new radiotracer called 64Cu-FBP8 for PET-MR imaging of thrombosis. The tracer has the potential of detecting thrombosis anywhere in the body, for instance in the left atrial appendage of patients with atrial fibrillation, and thereby may provide a non-invasive alternative to the current standard-of-care methods.
Diagnostic Validation of Wearable ECG Monitoring Patch, ATP-C120
Atrial Fibrillation New OnsetA new wearable patch-type device, ATP-C120 (ATsens, Seongnam, Korea) is a novel, single-lead ECG monitoring device and can continuously monitor the ECG signal for upto 11 days. This study is designed to experiment its diagnostic capability of new-onset atrial fibrillation in high risk patients. Several studies reported that validated CHA2DS2-VASc score has high performance in predicting new-onset atrial fibrillation and there are over 10 percent of new-onset atrial fibrillation in patients whose calculated CHA2DS2-VASc scores are ≥ 2. Thus, through this study, the investigators sought to evaluate the validation of early detection of new-onset atrial fibrillation by ATP-C120.
Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of...
Postoperative Atrial FibrillationStatins have rapid and significant actions that have potentially important (but not yet proven) implications for postoperative atrial fibrillation and cardiac protection in patients undergoing cardiac surgery. The focus of this study is, therefore, on patients having surgical aortic valve replacement (with aortotomy) and the development of postoperative atrial fibrillation (POAF). Our aims are: to investigate the risk of POAF, infection or other complications after SAVR in continuous versus preoperative discontinuous treatment with statins. The study is a single centre randomized controlled trial with continuance treatment with statin vs. discontinuance (7 to 14 days prior surgery until the 30th post-operative day included), on patients undergoing elective solitary SAVR with bioprosthesis with prior usage of statins the last 3 months and of at least 7 days. This randomized studies will address 2 separate hypotheses in patients undergoing open heart operation with solitary aortic valve replacement with a bioprosthetic valve that Discontinuation of HMG-CoA reductase inhibitors 7 to 14 days preoperative until 30 days postoperative of AVR in patients with prior use of HMG-CoA reductase inhibitors is not associated with increased early (<30 days) risk of POAF. Discontinuation of HMG-CoA reductase inhibitors 7 to 14 days preoperative until 30 days postoperative of AVR in patients with prior use of HMG-CoA reductase inhibitors is not associated with increased early (<30 days) and intermediate (<1 year) risk of mortality, MI, stroke and rehospitalisation.