Active clinical trials for "Atrial Fibrillation"

The "Long-term Outcome and Predictors for Recurrence after Medical and Interventional Treatment of Arrhythmias at the University Heart Center Hamburg" (TRUST) study is an investor-initiated, single-center, prospective clinical cohort study including patients treated with cardiac arrhythmias or at high risk for cardiac arrhythmias. The design enables prospective, low-threshold, near complete inclusion of patients with arrhythmias treated at the UHZ. Collection of routine follow-up data, detailed procedural information and systematic biobanking will enable precise and robust phenotyping.

Atrial fibrillation is the most common cardiac arrythmia globally. Its prevalence ranges between 2-4% worldwide. It is associated with significant morbidity and mortality. One of the main concerns of AF is the risk of thromboembolism, which can result in debilitating or detrimental stroke. The gold standard for preventing AF stroke is long term oral anticoagulation in the form of warfarin or NOAC1,2. Around 50% of patients who need anticoagulation are not on any form tablets and about 5% of patients who are not anticoagulated developed stroke. Some patients could not take anticoagulation because of high risk of bleeding, and this result in challenges within this cohort of patients. The left atrial appendage (LAA) is believed to be the main source of embolic in atrial fibrillation. The LAA is an anterolateral structure which is the smallest part of the left atrium. It originates anterior from the left pulmonary vein ostium. More than 90% of thromboembolic events happened in the LAA of non-rheumatic patients whereas only 57% of thrombi in rheumatic mitral valve disease3. This suggests that occluding the LAA is more beneficial in the non-valvular AF patients. Incomplete LAA closure is associated with a higher occurrence of thromboembolism. The growing evidence of LAA occlusion has been emerged. Percutaneous LAA Occlusion (LAAO) has been suggested that it may be considered for stroke prevention in patients with atrial fibrillation and contraindication for long term anticoagulation (class IIB, level B)1,2. This recommendation is based on the randomized controlled trials to show that percutaneous devices are non-inferior to oral anticoagulation in terms of preventing stroke in AF patients. Surgical LAA clip occlusion (LAAC) has emerged as a potential method to isolate LAA to prevent thromboembolism. The recent LAAOS III trial shows that the risk of ischemic stroke or systemic embolism was lower with concomitant left atrial appendage occlusion performed during the surgery than without it, most of whom continued to receive ongoing anticoagulant therapy4. This reinforced the mechanistic value of occluding the LAA in prevention of stroke. However, the efficacy of isolated LAAC without anticoagulation is uncertain. Besides, as this surgical clip occlusion is frequently performed together with other concomitant cardiac surgery, post evaluation in the form of imaging is lacking. Our study aims to study the imaging follow-up result and clinical efficacy of surgical and percutaneous left atrial appendage closure.

The outcomes regiStry for non-vitamin k antagonist oral anticoagUlants treatmeNt in variouS tHrombotIc dIseases for better cliNical practicE (SUNSHINE) is a multicenter, prospective, observational non-interventional inpatient/outpatient disease registry to assess the utilization of Non-vitamin k antagonist oral anticoagulants (NOACs), and associated outcomes. The SUNSHINE registry will focus on the collection and analysis of observational data in medical records from hospital information system (HIS) to evaluate the outcomes related with these NOACs when applied in extensive patient populations outside of clinical research studies. The registry will also allow for mainly combining the atrial fibrillation (AF) and venous thromboembolism (VTE) databases. In brief, the SUNSHINE registry will provide important information on the outcomes of NOACs in routine practice and gather further information on its safety and effectiveness.

In adult patients presenting to emergency departments within 24 hours of symptom onset with suspected acute stroke, we aim: to identify early brain- and pathology-specific circulating, whole blood, plasma and serum panorOmic biomarkers that enable early acute stroke detection, diagnosis, dynamics, differentiation, monitoring, prediction and prognosis. to identify early brain- and pathology-specific, panorOmic biomarkers in saliva that enable early acute stroke detection, diagnosis, dynamics, differentiation, monitoring, prediction and prognosis. to derive biomarker platforms of models for early acute stroke detection, diagnosis, dynamics, differentiation, monitoring, prediction and prognosis to validate these models in independent and external datasets

Cryoballoon pulmonary vein isolation (PVI) has emerged as an alternative to radiofrequency in the treatment of drug-resistant atrial fibrillation (AF). (1) Cryoablation offers potential advantages over radiofrequency, including shorter procedure times, decreased fluoroscopy time, shorter hospital length of stay, and different rates and types of complications. (2) The efficacy over a mean follow-up of one year with cryoablation for AF is comparable to that of radiofrequency ablation in a prospective randomized trial, with a lower major complication rate (3, 4). In recent years, AF cryoablation has established itself as a real alternative to RF ablation, to the point that this ablative source is chosen in one out of five European patients undergoing PV isolation. 70-80% of patients maintain sinus rhythm after a first procedure, showing an efficacy rate equivalent to ablation by RF. It is also comparable to RF when it comes to safety. Phrenic nerve palsy remains the major concern of cryoablation, accounting for 40% of periprocedural complications. A reduction in total procedure time and less dependence on the operator's experience make cryoablation an attractive choice for centres starting an AF ablation program. In conclusion, we do not yet have definitive data to affirm the superiority of one energy source over the other. Generally the choice depends on the availability of the centre and on the experience of the operator. Pulse field ablation (PFA): Vivek Y. Reddy demonstrates that in patients with paroxysmal atrial fibrillation, PFA rapidly and efficiently isolates PVs with a degree of tissue selectivity and a safety profile(1).PFA can achieve a high degree of durable PV isolation with a comparable efficiency than another techniques (RF or CRYO) at one year follow-up (2) Cryoablation has been a recognised technique for the ablation of atrial fibrillation for many years, with many studies comparing the technique to radiofrequency ablation with equal results. Studies are underway to compare radiofrequency AF ablation versus PFA (BEAT-AF study). A randomized study to compare two methods of cryoablation versus PFA will be necessary to validate the non-inferiority of the technique.

This study will enroll patients initiating Bruton Tyrosine Kinase (BTK) inhibitors without history of documented arrhythmia while on therapy using the Medtronic LINQ-2 insertable cardiac monitor (ILR). The incidence of new onset atrial fibrillation (AF) and other arrhythmia will be determined. Actions taken in response to device detected arrhythmia will be recorded.

Concomitant ablation is an effective treatment for patients with various types of atrial fibrillation undergoing heart surgery. However, recurrences of tachycardias after concomitant ablation can happen and seem to be mostly related to reentry mechanism resulting in atrial tachycardias. The aim of the study is to perform invasive re-mapping of ablated regions in the atria to assess durability of ablation lesions and prevalence of conduction gaps that can be targets for additional ablation to lower longterm arrhythmia recurrence.

Non-valvular atrial fibrillation (NVAF) increases the risk of stroke by three- to five-fold, especially in elderly patients, creating a huge burden on medical system as well as a negative impact on patients' lives. Direct oral anticoagulants (DOACs) are recommended for patients with NVAF to prevent strokes. Real world data reveal the underuse of anticoagulation in the elderly, especially due to physicians' concern of bleeding, often neglecting the thromboembolic risk. This study is designed to evaluate the safety and effectiveness of edoxaban in Korean elderly patients with atrial fibrillation.

Atrial Fibrillation (AF) is an abnormal heart rhythm. Because AF is often asymptomatic, it often remains undiagnosed in the early stages. Anticoagulant therapy greatly reduces the risks of stroke in patients diagnosed with AF. However, diagnosis of AF requires long-term ambulatory monitoring procedures that are burdensome and/or expensive. Smart devices (such as Apple or Fitbit) use light sensors (called "photoplethysmography" or PPG) and motion sensors (called "accelerometers") to continuously record biometric data, including heart rhythm. Smart devices are already widely adopted. This study seeks to validate an investigational machine-learning software (also called "algorithms") for the long-term monitoring and detection of abnormal cardiac rhythms using biometric data collected from consumer smart devices. The research team aims to enroll 500 subjects who are being followed after a stroke event of uncertain cause at the Emory Stroke Center. Subjects will undergo standard long-term cardiac monitoring (ECG), using FDA-approved wearable devices fitted with skin electrodes or implantable continuous recorders, and backed by FDA-approved software for abnormal rhythm detection. Patients will wear a study-provided consumer wrist device at home, for the 30 days of ECG monitoring, 23 hours a day. At the end of the 30 days, the device data will be uploaded to a secure cloud server and will be analyzed offline using proprietary software (called "algorithms") and artificial intelligence strategies. Detection of AF events using the investigational algorithms will be compared to the results from the standard monitoring to assess their reliability. Attention will be paid to recorded motion artifacts that can affect the quality and reliability of recorded signals. The ultimate aim is to establish that smart devices can potentially be used for monitoring purposes when used with specialized algorithms. Smart devices could offer an affordable alternative to standard-of-care cardiac monitoring.

The goal of this study is to compare effectiveness of cardioneuroablation of right anterior ganglionated plexus and pulmonary vein isolation in patients with enhanced vagal tone expressed as deceleration capacity >7.5ms.