Clinical Research Directory

Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation

Prospective multicenter observational study on resumption of anticoagulant therapy after major gastrointestinal bleeding in patients with atrial fibrillation

Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation

The STREAMLINE-PVI trial is a prospective, single-center, randomized, open-label clinical trial comparing pulsed field ablation (PFA) with cryoballoon ablation (Cryo) for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). A total of 94 patients undergoing first-time PVI will be randomized 1:1 to either PFA or Cryo within standardized Lean Six Sigma (LSS)-optimized procedural workflows. The primary objective is to evaluate whether PFA reduces total procedure duration by at least 20% compared with Cryo without compromising safety or efficacy. Secondary outcomes include post-procedural recovery, readiness for same-day discharge, atrial arrhythmia recurrence, AF burden, and procedural complications during a 12-month follow-up period.

AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG

This pilot study is designed to evaluate the clinical performance and utility of the SmartECG-EF software in patients undergoing evaluations at Inha University Hospital. The primary objective is to assess how effectively the device assists clinicians in evaluating cardiac function and related clinical parameters. The study will prospectively enroll eligible participants to gather real-world clinical data, contributing to enhanced diagnostic accuracy and patient management.

Cardiac Rehabilitation Needs Among Individuals With Atrial Fibrillation

The goal of this survey- and registry-based study is to learn about the cardiac rehabilitation needs of individuals with atrial fibrillation (AF). The main objectives of the study is to: 1. describe needs for CR as part of secondary prevention among individuals with AF. 2. assess eligibility and acceptance of referral to specific CR components based on individual patient-preferences, and their overlap with identified needs.

A Comparison of Beta-blockers and Calcium Channel Blockers in Atrial Fibrillation

Beta-blockers are generally prescribed for the treatment of atrial fibrillation. Their purpose is to slow the heart rate and thereby reduce the workload on the heart. However, beta-blockers can affect patients' quality of life, for example by reducing physical performance or causing fatigue in daily life. In this study, we aim to determine whether calcium channel blockers can improve the treatment of atrial fibrillation and have a positive impact on the quality of life of patients with atrial fibrillation compared with beta-blockers. We will also investigate how calcium channel blockers affect the physical exercise capacity. In addition, we will monitor potential side effects of both medications and explore whether there are any differences between women and men over the course of the study. Both study medications, the calcium channel blocker diltiazem and the beta-blocker bisoprolol, are approved by authorities and are recommended by the European Society of Cardiology for rate control in atrial fibrillation.

CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke

Early detection of atrial fibrillation detected after stroke (AFDAS) is crucial for secondary stroke prevention, as initiating direct oral anticoagulants (DOACs) can reduce atrial fibrillation (AF)-related stroke risk by up to 60%. In cryptogenic stroke (CS), AFDAS likely represents the most frequent underlying etiology, yet paroxysmal and short-duration AF episodes often elude standard monitoring. The Graz AF Risk Score, implemented across all Neurology Departments in Styria, Austria, stratifies patients into tailored monitoring pathways but remains limited by delays in implantable loop recorder (ILR) implantation, patient refusal, and restricted access to early ambulatory ECG monitoring. The study aims to close diagnostic gaps in the current AF detection pathway by implementing a non-invasive, wrist-worn photoplethysmography (PPG) device (i.e., CardioWatch 287-2 \[CW2\]) for early cardiac rhythm monitoring in CS patients. Methods: CATCH-AF is an investigator-initiated, prospective, longitudinal, multi-center, pre-post interventional study including all CS patients admitted to one of five Styrian Neurology Departments. In the pre-intervention phase, AF detection will follow the established Graz AF Risk Score-based algorithm. In the intervention phase, CardioWatch 287-2 screening will replace Holter-ECG screening in moderate-risk patients and will be used for high-risk patients with delayed or declined ILR implantation. Suspected AF episodes will be confirmed by ECG- based assessment at the discretion of the treating cardiologist. The primary endpoint isAFDAS detection at 3 months; secondary endpoints include AFDAS at 12 months, time to AF detection and DOAC initiation, cerebrovascular event recurrence, cardiovascular death, and all-cause mortality at 3 and 12 months. Data will be collected via REDCap and analyzed using descriptive, univariable, and multivariable regression methods, adjusted for confounders with inverse probability of treatment weighting. The investigators hypothesize that CardioWatch 287-2 implementation will increase early AFDAS detection and reduce diagnostic and therapeutic delays, potentially lowering recurrent cerebrovascular events and mortality over 12 months. CATCH-AF represents the first European, population-wide evaluation of a wrist-worn PPG device integrated into an established AF detection pathway for cryptogenic stroke, aiming to improve early diagnosis, treatment initiation and secondary prevention outcomes.

BOdygUardian MOnitoriNg for ReCurrencE of AF

The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the FARAPULSE Pulsed Field Ablation (PFA) System for the treatment of atrial fibrillation (AF). The data collected for this study will be from a subset of patients enrolled in the pre-existing DISRUPT AF Registry. Additionally, patients in the Full Monitoring Arm may be approached and consented for participation in BOUNCE-AF. The post-ablation monitoring timepoints will reflect the site's standard of care (SOC), which is typically at 6- and 12-months post-ablation. Consented patients will complete 1 survey about their experience after wearing the BodyGuardian at 6-months. Clinical staff that consent will also complete a survey on their experience using BodyGuardian. The clinical staff include those that either directly prescribe the monitor, place the monitor on the patient and/or train the patient on the use of the monitor, or those involved in reviewing the data.

A Comparison of Pulsed Field Ablation (PFA) vs Cryoablation for Atrial Fibrillation Under Deep Sedation

Pulsed Field Ablation (PFA) has created a 'paradigm shift' within cardiac electrophysiology and the initial experience demonstrates that PFA is safe, rapid and effective compared to both radiofrequency ablation and cryoablation in atrial fibrillation (AF). Presently, AF ablation procedures in the UK using PFA are routinely performed using general anaesthetic (GA) support requiring an anaesthetist and ODP being present in all procedures. This need significantly limits the ability to use PFA technology to perform AF ablations, particularly in centres that have limited availability of GA provision. The need for GA also leads to extended patient recovery time post procedure which impacts patient throughput and has the potential to reduce hospital bed availability. The need for GA and the potential to limit patient throughput has negative implications for all hospitals in terms of cost. PFA procedures performed elsewhere in Europe use deep sedation with IV propofol led by the ablating physician, but this is not permitted in the UK and still requires the presence of an anaesthetist. The investigators will aim to evaluate if AF ablation using PFA is feasible during spontaneous respiration without the use of propofol. The investigators will conduct a non-randomized study comparing AF ablation using PFA vs cryoballoon under deep sedation - aiming to demonstrate that \>75% of patients can complete the PFA protocol under deep sedation without conversion to cryoballoon (due to patient intolerance). The principal aim of the study is therefore not to demonstrate superiority or comparative efficacy of one ablation modality over another but rather the ability and feasibility to deliver pulsed field ablation under deep sedation. The use of cryoablation serves as a benchmark comparator to contextualise procedural and sedation-related observations.

Dual-Energy Lattice-Tip Assisted Marshall-Plan Strategy in Redo Persistent Atrial Fibrillation Ablation

This clinical trial will assess the efficacy and safety of a Marshall plan-based ablation strategy without ethanol infusion into the vein of Marshall in patients with persistent atrial fibrillation undergoing repeat ablation with a dual-energy lattice-tip catheter. Eligible participants will be randomized to receive either pulmonary vein re-isolation alone or pulmonary vein re-isolation plus the Marshall plan-based strategy. Patients who are found to have all pulmonary veins already isolated at the time of the procedure, or who are not suitable candidates for the Marshall plan-based approach, will be included in a separate observational cohort.

OPTION-EMEA Clinical Trial

The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case. The study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.

Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients

This is a multicenter, open-label, superiority randomized controlled trial enrolling adult patients aged 18 to 75 years. All participants have abdominal obesity (BMI ≥ 28 kg/m² with specific waist circumference standards) and non-valvular atrial fibrillation, and have successfully regained normal heart rhythm after their first catheter ablation. The study aims to compare the efficacy and safety of weekly mazdutide injection with conventional routine care in preventing heart rhythm recurrence within 12 months after ablation (excluding a 3-month early recovery blanking period). A total of 24 months will be spent recruiting participants, followed by a 12-month follow-up period. Participants are randomly divided into two groups. The intervention group receives escalating-dose mazdutide subcutaneous injections starting within 48 hours after ablation alongside standard health guidance on diet, exercise and lifestyle. The control group only receives the same routine health guidance without mazdutide treatment. The primary efficacy endpoint is recurrence of atrial arrhythmias (including AF, atrial flutter, and atrial tachycardia) recorded on a standard 12-lead surface ECG for ≥10 seconds, or on a 24-hour Holter monitor (including single-lead ECG patches) for \>30 seconds, at 12 months after a single ablation procedure (after a 3-month blanking period), without the use of any Class I/III antiarrhythmic drugs (AADs).

Peri-procedural Hydration to Prevent Acute Kidney Injury After Pulsed Field Ablation for Atrial Fibrillation

PFA is an emerging non-thermal ablation technology with favorable procedural safety; however, recent studies have raised concerns about peri-procedural hemolysis and subsequent AKI after PFA. This study is a single-center, open-label, randomized controlled trial designed to evaluate whether standardized peri-procedural intravenous hydration can reduce the risk of acute kidney injury (AKI) after pulsed field ablation (PFA) for atrial fibrillation (AF). Eligible adult patients with symptomatic paroxysmal or persistent AF scheduled for PFA will be randomly assigned in a 1:1 ratio to either a standardized hydration strategy or a control strategy without routine prophylactic hydration. The hydration group will receive 0.9% saline at 2 mL/kg/h from entry into the electrophysiology laboratory until 12 hours after the procedure, while the control group will receive no routine preventive hydration and will be treated with fluids only if clinically indicated. The primary outcome is any in-hospital AKI defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Secondary endpoints include in-hospital AKI severity by KDIGO stage, in-hospital persistent moderate-to-severe AKI, in-hospital renal replacement therapy, changes in renal function after the procedure, and clinical outcomes through 30 and 90 days, including all-cause death, persistent AKI, renal replacement therapy, all-cause rehospitalization, and composite major adverse events.

Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care for Atrial Fibrillation and Heart Failure Comorbidity in Rural China (MOVE-AF HF)

AF and HF frequently coexist and are associated with poor clinical outcomes. In rural areas, limited access to echocardiography, NT-proBNP testing, and specialist care may hinder the early identification and appropriate management of HF among patients with AF. Mobile clinics may help overcome these barriers by bringing diagnostic testing and specialist support directly to rural communities. This cluster-randomized controlled trial aims to evaluate a mobile clinic-supported, village doctor-led model for HF screening and integrated management among older patients with AF in rural China. Mobile clinics equipped with echocardiography and NT-proBNP testing will support HF screening, and subsequent management will be tailored according to HF status. The study will evaluate whether this model can improve the detection of HF and reduce adverse cardiovascular events compared with routine management.

Mechanisms of Myocardial Injury and Ischemia in Patients With Rapid Atrial Fibrillation

The goal of this observational study is to better understand the role of measuring troponin (a protein measured by a blood test) and coronary imaging in patients presenting with rapid atrial fibrillation (AF) The main questions this study aims to answer are: 1. Are patients with a fast, irregular heartbeat (rapid AF) and damage to the heart (myocardial injury) more likely than those without damage to the heart to have blocked heart arteries (obstructive coronary artery disease) 2. Are patients with a fast, irregular heartbeat (rapid AF) and damage to the heart (myocardial injury) with further evidence that their heart hasn't been getting enough oxygen (myocardial ischemia) more likely to have imaging evidence of myocardial infarction than those without myocardial ischemia To do this, we will measure troponin in patients with rapid AF and then carry out further investigations of the heart (electrocardiogram, echocardiogram, CT scan and cardiac MRI)

Association Between Circulating BDNF Levels and Atrial Cardiomyopathy in Patients Undergoing Ablation for Persistent Atrial Fibrillation

trial fibrillation (AF) is the most common cardiac arrhythmia worldwide, and its prevalence continues to rise. AF is associated with serious complications, including embolic strokes, heart failure, and mortality. Characterized by rapid, irregular, and weakened contractions of the atria, AF is considered one of the "visible" electrophysiological manifestations of a broader condition known as atrial cardiomyopathy (ACM). Disruption of normal blood flow in the atrium, particularly in the context of an endocardium predisposed to thrombosis, predisposes to thrombus formation. Once dislodged from the atrial cavity and migrating to the cerebral arteries, these thrombi can cause a cardioembolic stroke. The main risk factors for ACI/AF are metabolic syndrome and aging. CMA is a condition that is difficult to diagnose because it is not clearly defined, except through histological analysis. Guided by the results of our experimental approaches, we aim to address this challenge by approaching CMA through one of its complications: persistent atrial fibrillation. Indeed, CMA can be assessed using electroanatomical mapping during atrial fibrillation ablation (AFA) procedures. During radiofrequency ablation of AF, electroanatomical mapping of the left atrium is performed to measure left atrial voltage, which serves as an indirect marker of the presence of atrial fibrosis, strongly associated with CMA. Other parameters relevant to the identification of CMA can be assessed during this procedure, such as conduction velocities and specific electrographic characteristics. We plan to include 150 patients undergoing ablation for persistent atrial fibrillation at the Dijon Bourgogne University Hospital and to correlate circulating levels of BDNF (brain-derived neurotrophic factor) with electroanatomical mapping data of the left atrium. The electrical remodeling of the left atrium, including low-voltage areas and conduction velocity, as well as left atrial morphology assessed by pre-procedural cardiac computed tomography using the ADAS3 Galgo LA Module software, will be correlated with BDNF levels. Blood samples for BDNF assessment will be collected before or at the start of the ablation procedure, prior to any catheter insertion into the vessels. While investigating the association between BDNF levels and CMA characteristics during AF ablation, thereby confirming the pathophysiological relationship with atrial remodeling, our objective is also to evaluate the prognostic role of BDNF levels in clinical and rhythm outcomes following AF ablation. Thus, we will compare changes in BDNF levels after AF ablation at one-year follow-up, correlating them with the evolution of CMA-based on left atrial parameters assessed by echocardiography or cardiac computed tomography-autonomic nervous system balance and heart rhythm obtained via Holter monitoring, as well as clinical outcomes.

Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study

This study aims to investigate whether a quick, additional CT scan of the heart, performed immediately after a standard CT scan for pulmonary embolism, can effectively detect blood clots in the left atrial appendage (LAA) in patients with atrial fibrillation. Detecting these clots is crucial before certain heart procedures to prevent stroke. Currently, a different, more involved procedure (Transesophageal Echocardiography - TEE) is often used. This study will assess if this additional CT scan is feasible, meaning if it can provide clear enough images to identify LAA clots without needing more contrast dye. The study will involve 60 patients, half receiving an "ungated" CT scan and the other half a "gated" CT scan (timed with their heart rhythm). The results of these scans will not be used for immediate patient care during the study, but rather to evaluate the CT scan technique itself. There is no direct benefit to participants, but the information gained could lead to faster diagnosis and reduced unnecessary testing for future patients.

Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. The aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with atrial fibrillation and how it compares against participants that will receive apixaban in this study. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration

The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.

FARAPULSE Workflow Assessment Registry

The study is designed to determine the best practices in the patient pathway, and to analyze pre-procedural, procedural and follow-up workflow data related with ablation of atrial fibrillation where the FARAPULSE™ Pulsed Field Ablation System is used in a commercial and standard of care setting. Workflow-related variables, inclusive of pre-procedural imaging, methods of transseptal access, anesthesia/sedation technique, intracardiac mapping, ablation settings, dosing strategy, lesion sets and general procedure management, will be used to identify predominant workflow schemes that will be associated with patient demographics, procedure-related complications (safety parameters), and one-year effectiveness parameters. The study data can be used for procedural workflow optimization when using Pulsed Field Ablation for the ablation treatment of Atrial Fibrillation based on patient demographics, cardiac anatomy and arrhythmia characteristics.

Pilot Study to Determine the Optimal Protocol for Preoperative Transcutaneous Vagal Neurostimulation

Post-operative atrial fibrillation (POAF) is a frequent complication of surgical aortic valve replacement, affecting 38 to 63% of patients, and increasing risks of stroke, heart failure, and long-term mortality. By intervening upstream of surgical stress, transcutaneous vagal nerve stimulation (tVNS) could act as an autonomic and anti-inflammatory preconditioning, stabilizing sympathovagal balance, reducing POAF susceptibility and post-operative outcomes. This pilot study evaluates the feasibility, tolerability, and biological activity of a preoperative tVNS protocol versus sham (1-2 hours/day), with ΔRMSSD, a non-invasive marker of parasympathetic modulation as the primary endpoint, inflammatory biomarkers, postoperative recovery, and cardiovascular events up to 3 months as secondary outcomes. This step is essential to identify a preoperative strategy that is practicable, well-tolerated, and capable of inducing measurable parasympathetic modulation prior to surgery and the prevention of POAF.

A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation

The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins and LA Posterior Wall (PVI+ PWA) in the treatment of de novo symptomatic drug-refractory persistent atrial fibrillation (PersAF).

A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation

The goal of the ReDEFINE-AF Clinical Study is to evaluate the safety and effectiveness of the FARAFLEX™ Mapping and Pulsed Field Ablation System with electrographic flow mapping in subjects undergoing repeat ablation for atrial fibrillation (AF).

Conduction Breakthrough in the Coronary Sinus Post Endocardial Mitral Isthmus Ablation

The goal of this observational study is to learn more about how doctors can create a complete electrical block in the heart during catheter ablation procedures used to treat certain abnormal heart rhythms. The main questions it aims to answer are: * How often do electrical signals continue to travel through a blood vessel around the heart after ablation? * Which ablation applications are most important for achieving a successful electrical block? * How do different procedural factors affect the success of the treatment? Participants who undergo a catheter ablation procedure as part of their normal medical care may take part in this study. No additional tests, visits, or procedures will be required. Researchers will collect information that is routinely recorded during the procedure to better understand how electrical signals travel in the heart and how ablation procedures can be improved.

Reliability of Multiple-Repetition-Maximum Tests in Patients With Cardiovascular Disease or Risk Factors

Exercise training is a cornerstone in the prevention and rehabilitation of cardiovascular disease. While research has primarily focused on endurance training, resistance training becomes more and more important. The gold standard to prescribe resistance training intensity or monitor longitudinal changes is the 1-Repetition-Maximum (1-RM) test. However, particularly for unexperienced individuals, this test may not be recommendable due to the high load and an increased risk of injuries. Alternatively, there are several published formulas to estimate the 1-RM based on a multiple-repetition-maximum (or repetition-to-failure) test. However, these formulas have been primarily tested in healthy individuals. Moreover, the reliability of the 1-RM estimation based on two tests with different submaximal weight is unknown. Therefore, the present study evaluates the agreement of the 1-RM estimation (based on different formulas) between two Multiple-RM tests with different weight in 50 patients with cardiovascular disease (heart failure, coronary heart disease, atrial fibrillation) or cardiovascular risk factors (type 2 diabetes, arterial hypertension).