Atrial Fibrillation

The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with the new VARIPULSE™ Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year and doesn't stop on its own).

Atrial fibrillation (AF) often starts with short episodes of rapid irregular heartbeats that are only detected by implanted pacemakers or defibrillators. Usually people don't know that they have these episodes. Over time, these episodes can happen more often and last for longer periods. In some people, the heart eventually remains permanently in a fast irregular rhythm, known as atrial fibrillation. This condition can lead to strokes and blood clots. If physicians could detect atrial fibrillation at a very early stage they could treat people early and possibly prevent the condition from becoming permanent. People with implanted devices allow a unique opportunity to constantly monitor the heart rhythm so investigators can detect any irregularities immediately. Investigators don't know which people are at risk of developing short episodes of fast irregular heartbeats that can lead to atrial fibrillation. The purpose of this study is to find out if there are proteins or chemical changes in the blood that can predict the risk of developing atrial fibrillation. These chemical changes, also known as biomarkers, may also be able to give investigators other clues about atrial fibrillation.

Cardiovascular-kidney-metabolic (CKM) syndrome is a systemic disorder characterized by pathophysiological interactions among metabolic risk factors, chronic kidney disease, and the cardiovascular system, leading to multiorgan dysfunction and increased risk of atrial fibrillation, stroke, and heart failure. Atrial cardiomyopathy (ACM) - defined as any structural, contractile, or electrical abnormality of the atria - is an increasingly recognized contributor to cardiovascular morbidity and mortality in this population. Despite growing interest in both conditions, their interplay remains poorly understood, limiting effective preventive strategies and risk-stratification approaches for this high-risk group. CKM staging offers a practical framework for anticipating ACM onset and progression. Because adiposity-driven inflammation, insulin resistance, hypertension, and early kidney injury act as upstream drivers in CKM, the left atrium becomes an early indicator of hemodynamic load and fibrosis - often preceding sustained atrial fibrillation. Early non-invasive detection of ACM across CKM stages could shift care from treating complications to modifying the underlying substrate. This prospective observational single-center cohort study aims to phenotype ACM non-invasively across all CKM stages at first diagnosis, using standard 12-lead ECG, advanced transthoracic echocardiography with speckle-tracking, a mechanistically selected biomarker panel (NT-proBNP, MR-proANP, Fetuin-A, FGF23), and cardiac MRI. Adults aged 18 years or older presenting for cardiovascular evaluation are enrolled and grouped as CKM with ACM (study group) versus CKM without ACM (control group). All participants undergo a single standardized baseline evaluation including clinical examination, 12-lead ECG with Bayés interatrial block grading, comprehensive laboratory panel, and advanced echocardiography including left atrial global longitudinal strain by speckle-tracking. Primary objective: characterize the relationship between ACM and CKM syndrome stages using non-invasive parameters at first diagnosis. Secondary objectives include assessment of clinical, biological, ECG, and imaging profiles of ACM in CKM; evaluation of left atrial function across CKM stages; examination of Bayés interatrial block correlations and the impact of SGLT2 inhibitors and GLP-1 receptor agonists on left atrial remodeling in HFpEF; and identification of independent ACM risk factors incorporating the full biomarker panel. Statistical analyses include multivariable logistic regression, biomarker ROC analyses, and penalized regression for derivation of a pragmatic ACM risk score with internal validation. Expected outputs include prevalence estimates, effect sizes for ACM and CKM joint categories, biomarker performance metrics, and a clinic-ready checklist for risk-stratified prevention in outpatient settings.

Atrial fibrillation (AF) is a type of irregular heart rhythm due to electrical signal disturbances of the heart. It is a very common arrhythmia and the risk of developing AF increases with age and with other risk factors such as diabetes, high blood pressure, and underlying heart disease. The main complications of AF are heart failure and stroke. However, studies have shown that restoration of normal rhythm does not reduce these complications. Rather, these complications are mitigated by controlling the heart rate and using blood thinners to prevent stroke. Symptoms secondary to AF can occur due to the irregular heart rate and poor contraction in the atria, the top chambers of the heart. These symptoms include shortness of breath, fatigue, reduced exercise tolerance, and palpitations. Restoring sinus rhythm can sometimes alleviate these symptoms. Given that studies to date have not shown a difference in hard clinical endpoints between rate and rhythm control strategies, the decision to proceed with rhythm control depends on the patient symptom burden. Rhythm control strategies in patients with persistent AF include cardioversion back to sinus rhythm with long-term recurrence prevention via anti-arrhythmic drugs (AADs) or catheter ablation. However, many studies of these procedures omit a sham placebo control arm. No atrial fibrillation procedural intervention has been compared to a sham procedure. The cardioversion procedure can easily be compared to a "sham" alternative, as it is non-invasive with an expected response within days-to-weeks. Thus, a cardioversion versus "sham" cardioversion trial will allow us to truly assess the impact of a rhythm-control strategy on QOL. It is hypothesized that cardioversion of atrial fibrillation leads to significant improvement in quality of life (QOL) compared to sham cardioversion. Understanding the true QOL impact of sinus rhythm restoration in patients with persistent AF is of significant importance in guiding strategies for the management of AF. Hence, by evaluating what the true effect of cardioversion on QOL in this blinded study, we can better understand the role of medical management and AF ablation in our patients and assess resource allocation to these procedures.

The aim of this study is to test the efficacy of the CE-marked wearable system Stroke Alarm to identify the onset of a stroke with unilateral arm motor deficit within 3 hours of onset. This is a multicenter, prospective observational single-arm trial with a registry-based propensity matched control population. A total of 500 patients will be included in the trial. An interim analysis will determine if the stroke onset frequency is sufficient to determine the main outcome. Should the number of stroke events differ from what is expected at interim analysis, study enrollment will continue to increase cohort size. Patients who meet the criteria for participation will, after signing consent, be included and receive the Stroke Alarm bracelets that are used for 3 months. Study data will be collected as baseline at inclusion, at follow-up 3 months after inclusion and by using national Swedish registry data after completion of the study. Patients with elevated stroke risk according assessed by presence of specific criteria associated with elevated risk caused by: 1. recent TIA with an ABCD2 score of ≥6, large artery atherosclerosis or atrial fibrillation, OR 2. recent ischemic stroke with large artery atherosclerosis or atrial fibrillation, without persisting arm motor deficit, OR 3. atrial fibrillation with an CHA2DS2-Vasc score ≥ 4 without adequate anticoagulation OR 4. recent hemorrhagic stroke with atrial fibrillation, without persisting arm motor deficit The combined efficacy goal is at least 60% sensitivity for Stroke Alarm b of stroke with unilateral arm motor deficit within 3 hours of onset (with a 95% confidence interval above 30%) and a specificity of at least 80% using a clinical stroke diagnosis as gold standard. A control population matched for calendar year, age (± 5 years), sex, healthcare region, baseline stroke severity according to the National Institutes of Health Stroke Scale (NIHSS, ± 5 points), unilateral arm motor deficit (NIHSS item 5a/5b 1-4), presence of neglect/inattention (NIHSS item 11 1-2), atrial fibrillation, cohabitation status and pre-stroke functional level twill be identified in the Swedish national stroke registry, Riksstroke, and used for comparison.

Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some patients find it difficult to tolerate medications and suffer side effects from these treatments. In these instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker. A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). There is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of CSP with AV node ablation to optimal medical therapy for treating AF.

U-SCREEN is a randomized controlled trial evaluating whether systematic home-based multimodal screening for cardiovascular risk conditions, offered to residents in Region Uppsala turning 50, 55, 60, 65, 70 or 75 years of age, can identify clinically actionable cardiovascular risk factors more effectively than usual care. Participants randomized to the screening arm receive a home blood pressure measurement device, a dried blood spot sampling kit (for ApoB, HbA1c and creatinine), and a digital questionnaire. The control arm receives usual care. Recruitment runs 2024-2027 with a target identification of 10,000 cardiovascular risk conditions.

The objective of this feasibility study is to evaluate the safety and effectiveness of the FARAFLEX mapping and pulsed field ablation (PFA) catheter, a novel catheter in treating persistent atrial fibrillation (PersAF) or symptomatic Paroxysmal Atrial Fibrillation (PAF).

Postoperative atrial fibrillation is quite common after cardiac surgery with up to 1 in 3 patients experiencing this abnormal heart rhythm. Amiodarone, a medication commonly used to treat atrial fibrillation, has been previously shown to be an effective prophylactic agent at decreasing the occurrence of postoperative atrial fibrillation in patients who underwent coronary artery bypass surgery. However, despite many studies which have demonstrated its effectiveness, it has not been widely used due to the concern of side effects that can occur such as slow heart rate, low blood pressure, and lung toxicity. We have designed a study to test the effectiveness and safety of a short course of postoperative prophylactic amiodarone for patients undergoing non-coronary artery bypass cardiac surgery. We hypothesize that patients who receive the prophylactic amiodarone will have decreased rates of postoperative atrial fibrillation without significantly increased side effects compared to patients who receive the standard postoperative care after non-coronary artery bypass cardiac surgery.

The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.

The primary objective of the TRAC-AF Registry is to capture real-world safety and effectiveness data on AtriCure devices used to conduct open concomitant and/or hybrid ablation, and management of the LAA concomitant to a cardiac ablation.

Background and Significance: In the United States approximately 220,000 patients undergo cardiac surgery per annum. Among potential complications, the incidence of atrial fibrillation (AF) is estimated at 30 - 60 %, and therefore presents the most common adverse event after cardiac surgery. Multiple complications may be associated with AF: Patients are usually subject to an increased length-of-stay in the intensive care unit and in the hospital. Furthermore, the risk for stroke and development of long-term AF is elevated, while further anticoagulation is required putting the patient at risk for bleeding. On average, an additional $10,000 - $20,000 is spent for each patient with AF. However, the exact burden of postoperative AF still remains unknown. Specific Aims of Research Project: 1. To collect data from an electrocardiogram (EKG) monitoring patch, we aim to accurately determine the prevalence of atrial fibrillation in patients undergoing cardiac surgery at our center. 2. To collect data on epidemiological characteristics to investigate risk factors for developing perioperative atrial fibrillation in patients undergoing cardiac surgery. This will allow us to create robust risk prediction models.

Pulmonary vein isolation (PVI) by catheter ablation (CA) has become a widely accepted interventional treatment for patients with symptomatic atrial fibrillation (AF) despite anti-arrhythmic drugs (AAD). Classic thermal ablation modalities use radiofrequency energy or cryo-energy to create cardiac tissue lesions. Irreversible electroporation (IRE) using pulsed field energy (PFA) is a novel technology for cardiac tissue ablation. Initial studies have shown favorable outcome data in patients with AF treated by performing PVI using PFA. However, the freedom of AF has not yet proven superior to existing thermal ablation methods and appears similarly associated with suboptimal lesion durability, leading to electrical reconnection. The purpose of this study is to determine if freedom of atrial fibrillation may be improved by delivering more and better targeted pulsed field ablations.

* The goal of the screening trial is to determine whether early screening for atrial fibrillation improves outcomes, including lowering the chance of death, hospitalization for stroke, blood clots, heart failure, heart attack, and severe bleeding reduces the risk of stroke or heart failure. * Atrial fibrillation is a common heart condition in which one of the heart chambers doesn't follow a normal rhythm. Blood clots can form as a result, and they can travel to the brain and cause strokes, or to other organs. * Almost everyone with atrial fibrillation is treated with drugs called anticoagulants ("blood thinners") to reduce the risk of stroke. These drugs also increase the risk of bleeding. * Testing for atrial fibrillation is usually done for patients who have symptoms of an irregular or unusually fast or slow heartbeat, often called "palpitations" or a sensation of the heart pounding or stopping for a short period of time. * What is not known is whether screening people who do not have symptoms of atrial fibrillation, but who are at above-average risk of getting atrial fibrillation, will reduce death, hospitalization for stroke, blood clots, heart failure more than it increases hospitalization for severe bleeding. * People who participate in the trial who are selected by chance to receive screening will wear a small heart-rate monitor (Zio Patch) on their skin for 14 days and then return it to the manufacturer. Their doctors will be notified about the results and will make decisions about any treatment to recommend. * The screening trial is expected to enroll about 24,000 VA patients nationwide and to last 7 years, but each person's active participation in the trial is completed after sending in the Zio Patch. After that, the study team will just collect information from the participant's electronic medical records.

The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.

Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure.

The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; PVI and SVCI), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation.

* The trial will compare two anticoagulants ("blood thinners") that are currently used in the VA and are considered standard care to prevent strokes in patients with atrial fibrillation. The two most commonly-used anticoagulants will be compared: apixaban (Eliquis) and rivaroxaban (Xarelto). They are considered by many doctors to have similar benefits and risks, but no one knows for sure. * The trial only enrolls patients with a diagnosis of atrial fibrillation ("A Fib") or atrial flutter. Most participants will be age 65 or older, and should already be taking apixaban or rivaroxaban. * The investigators will measure, in about 10,000 VA patients nationally, whether the rates of stroke, major bleeding, or death differ between these two drugs. * The trial will last about 7 years, but after the first prescription, all information will be collected from electronic medical records.

This PMCF study "VOLTAIRE-AF" will allow to observe acute and long-term safety and performance outcomes of the last generation of Volta Medical AI software (Volta AF-Xplorer II) during AF ablation using next-generation mapping and ablation technologies over a 24-month follow-up and in "real life"clinical practice, without any imposed clinical workflow.

Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF. Despite DOAC therapy, there is a significant residual stroke risk of 1-2%/year. Recent data from the Swiss Stroke Registry found 38% of patients with AF and ischemic stroke were on prior anticoagulant therapy (approximately 400 patients per year in Switzerland). The investigators found in a prior observational study, that patients with AF who have ischemic stroke despite anticoagulation are at increased risk of having another ischemic stroke (HR 1.6; 95% confidence interval, CI 1.1-2.1). Combining observational data from 11 international stroke centres, the investigators found that the majority of ischemic strokes despite anticoagulation in patients with AF is "breakthrough" cardioembolism (76% of patients) and only a minority of 24% is related to other causes unrelated to AF. Optimal secondary prevention strategy is unknown. The investigators have conducted two independent observational studies including together \>4000 patients but did not identify any strategy (e.g. switch to different DOAC, additional antiplatelet therapy) that seems superior. A recent randomized controlled trial on surgical occlusion of the left atrial appendage (LAAO) found that LAAO may provide additional protection from ischaemic stroke in addition to oral anticoagulation. Triggered by this finding, the investigators performed a matched retrospective observational study and found that patients with AF and stroke despite anticoagulation who received a combined mechanical-pharmacological therapy (DOAC therapy + LAAO) had lower rates of adverse outcomes compared to those with DOAC therapy alone. Therefore, the investigators hypothesize that in patients with AF and ischemic stroke despite anticoagulant therapy, LAAO in addition to anticoagulation with a DOAC is superior to DOAC therapy alone. The investigators propose an international, multi-center randomized controlled two-arm trial to assess the effect of LAAO in patients with AF suffering from strokes despite anticoagulation therapy and without competing stroke etiology. The investigators will use the PROBE design with blinded endpoint assessment. The investigators will enrol patients with non-valvular AF and a recent ischemic stroke despite anticoagulation therapy at stroke onset. Patients will be randomized 1:1 to receive LAAO + DOAC therapy (experimental arm) or DOAC therapy alone (standard treatment arm). The primary endpoint is the first occurrence of a composite outcome of recurrent ischemic stroke, systemic embolism and cardiovascular death during follow-up. Secondary outcomes include individual components of the primary composite outcome, safety outcomes (i.e. symptomatic intracranial haemorrhage, major extracranial bleeding, serious device- or procedure-related complication), functional outcome (modified Rankin Scale) and patient-oriented outcomes. The minimum follow-up is 6 months and all patients will receive follow-ups every 6 months until end of study, the maximal follow-up will be 48 months. Based on prior observational data from the investigators' group and others (5 observational studies, \>5000 patients), the investigators estimate the proportion of patients with the primary outcome in the standard treatment arm to be 18% in the first year and 9% in the second year (=cumulative 27% after 2 years). A relative risk reduction of 40% at 2 years would be clinically relevant. Based on these assumptions and a log-rank test, the investigators would need 98 events for a power of 80% at an alpha-level of 5%. Assuming a recruitment rate of 52, 118, 156 and 156 patients in years 1 to 4, an additional 6 months of follow-up (mean follow-up time of 2.1 years) and a uniform drop-out rate of 7.5% per year, 482 patients would need to be enrolled. How to treat patients with an ischemic stroke despite anticoagulation is a major yet unresolved clinical dilemma. This trial has the potential to answer the question whether LAAO plus DOAC therapy is superior to current standard of care for patients with AF who have ischemic stroke despite anticoagulation.

More than 25% of patients referred for diagnostic coronary angiography and percutaneous coronary intervention (PCI) due to acute coronary syndrome (ACS) suffer from non-valvular atrial fibrillation (AF). In this particular setting, balancing between the prevention of thrombosis and the risk of bleeding remains challenging. Oral anticoagulation (OAC) prevents stroke and systemic embolism, but has not been shown to prevent stent thrombosis (ST). Dual antiplatelet therapy (DAPT) reduces the incidence of recurrent ischemic events and ST, but is less effective in reducing the incidence of cardioembolic stroke associated with AF. A common guideline-supported practice is to combine three drugs (OAC, aspirin and clopidogrel) in a triple therapy, which is associated with high annual risk (up to 25%) of major bleeding. Thus, new therapeutic strategies are urgently needed to maintain the efficacy while improving the safety of treatment in patients with AF and ACS undergoing PCI. This is a prospective, randomized, open-label, blinded-endpoint, non-inferiority trial. 1194 patients with non-valvular AF that had undergone successful PCI due to an ACS within the previous 120 hours will be randomized in 1:1 ratio to receive one of the two treatments: dual therapy with dabigatran (150 mg twice daily or 110 mg twice daily) and ticagrelor (90 mg twice daily for 1 month, followed by 60 mg twice daily up to 12 months), or standard therapy according to current guidelines triple therapy with dabigatran (150 mg b.i.d. or 110 mg b.i.d.) plus clopidogrel (75 mg o.d.) plus aspirin (75 mg o.d.) followed by double therapy depending on the bleeding and ischaemic risk. Study treatment will be continued for 12 months. The primary study end-point is the first major or clinically relevant non-major bleeding event (per ISTH), in a time-to-event analysis. The main secondary end-point is a composite efficacy end-point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization (PCI or coronary artery bypass grafting) at 12 months. We expect that dual antithrombotic therapy including reduced dose ticagrelor and dabigatran is at least non-inferior regarding bleeding risk and ischaemic protection, compared to the standard triple therapy in patients with AF and after ACS, treated with PCI.

The Left Atrial Appendage Occlusion Registry (LAAO Registry™) is designed to assess the prevalence, demographics, management, and outcomes of patients undergoing percutaneous and epicardial based left atrial appendage occlusion procedures to reduce the risk of stroke. Patient-level data will be submitted by participating hospitals on a quarterly basis to the American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR). The primary aims of the LAAO Registry are to optimize the outcomes and management of patients through the implementation of evidence-based guideline recommendations in clinical practice, facilitate efforts to improve the quality and safety for patients undergoing percutaneous and epicardial based left atrial appendage procedures, investigate novel quality improvement methods and provide risk-adjusted assessment of patients for comparison with nationwide NCDR data. The secondary purpose of the LAAO Registry is to serve as a rich source of clinical data to support assessments of short- and long-term safety, comparative and cost effectiveness research, and as a scalable data infrastructure for post market studies.

This post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF).

The clinical equipoise in the treatment of Atrial Fibrillation (AF) in patients with Heart Failure with mildly reduced Ejection Fraction/Heart Failure with Preserved Ejection Fraction (HFmrEF/HFpEF) reflects the scarcity of randomized trials on different treatment modalities. By generating high-quality, evidence-based, randomized data on the impact of treatment on hard outcomes, Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients with Heart Failure with Preserved Ejection Fraction (CASTLE-HFpEF) will provide clinical decision-making guidance and help physicians in the management of patients with HFmrEF/HFpEF and AF. The main hypothesis is that Catheter Ablation (CA) for AF is associated with improved clinical outcomes in patients with HFmrEF/HFpEF and AF compared to medical AF treatment strategies on top of optimal medical HF treatment. CASTLE-HFpEF aims to study these hard clinical outcomes in a randomized cohort of patients with AF and HFmrEF/HFpEF.

The study aims to evaluate and compare the incidence of atrial arrhythmias (including Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. The investigators hypothesize that patients with a higher baseline Utah fibrosis staging will experience a higher incidence of POAF. The study also aims to evaluate and compare the in-hospital mortality, length-of-stay (LOS), complication rates (strokes, pneumonia, respiratory failure etc.) of the different Utah fibrosis stage cohorts. Perform cost analysis and compare between patients with POAF and patients without POAF. The investigators hypothesize that patients experiencing POAF will have a higher mortality rate, longer LOS, greater complications, and therefore, additional hospital costs.