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Showing 1-20 of 64 trials
NCT07444372
Atrial fibrillation (AF) is one of the most common clinical arrhythmias. Catheter ablation is an effective therapeutic strategy; however, recurrence rates remain substantial, ranging from 20% to 45%. Previous studies have established a strong association between obstructive sleep apnea (OSA) and the risk of AF recurrence following ablation. While continuous positive airway pressure (CPAP) is the standard intervention for OSA, and some observational studies suggest it may reduce post-ablation recurrence in patients with comorbid OSA, small randomized controlled trials have failed to confirm a clear benefit, potentially due to poor adherence. This study aims to evaluate the clinical benefit of post-ablation CPAP therapy in AF patients with comorbid OSA. Participants will: * Be randomly assigned to either the CPAP group or the usual care group. * If in the CPAP group, use a CPAP device for 12 months. * Wear an ambulatory ECG recorder for a 7-day period at 3, 6, 9, and 12 months post-operation. * Complete follow-up checkups either at the clinic or over the phone at 1, 3, 6, and 12 months after their procedure.
NCT07490808
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.
NCT06706518
While radiofrequency and cryoballoon ablation have shown high rates of pulmonary vein reconnection in patients undergoing repeat electrophysiological evaluation for AF recurrence, early evaluations demonstrated a remarkably high rate of durable PVI with pentaspline pulsed field ablation (P-PFA). These observations suggested that PFA could mitigate the historical limitations of thermal ablation related to late PV reconnection and positioned the technology as a potentially robust solution for long-term lesion durability. However, real-world experience including data from large volume centers beyond initial learning curve, has revealed a non-negligible incidence of reconnections, comparable to those historically observed with thermal ablation and persisting even in the most contemporary datasets. These findings highlight the need to optimize procedural strategies to maximize lesion durability while maintaining procedural efficiency. Although fluoroscopic guidance remains standard practice in many centers, the adoption of intracardiac echocardiography (ICE) and electroanatomic mapping (EAM) to support device navigation is increasing, with the potential to improve lesion quality at the expense of greater complexity and resource utilization.
NCT07496281
The OPTIA-AF trial is a prospective, multicenter randomized controlled trial designed to evaluate a rhythm-guided antithrombotic strategy in patients with atrial fibrillation (AF) who maintain durable sinus rhythm after catheter ablation and have a history of prior drug-eluting stent (DES) implantation. Current guidelines generally recommend long-term oral anticoagulation (OAC) in patients with AF, even after successful ablation, while antiplatelet therapy remains essential for prevention of coronary ischemic events following percutaneous coronary intervention. OPTIA-AF tests whether discontinuation of non-vitamin K antagonist oral anticoagulant (NOAC) therapy with transition to single antiplatelet therapy (SAPT) is non-inferior to continued NOAC therapy in patients who maintain sinus rhythm for at least 12 months after AF ablation. Participants will be randomized in a 1:1 ratio to either continued NOAC therapy or NOAC discontinuation with SAPT. The primary endpoint is a 24-month composite net clinical outcome including ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding.
NCT07486739
The objective of this study is to evaluate whether an AI-ECG based screening strategy for detecting cardiac functional and structural abnormalities preserves clinical effectiveness and safety, compared with a conventional strategy of routine echocardiography in patients with AF, thereby demonstrating the non-inferiority of AI-ECG guided care.
NCT06935591
The goal of this clinical trial is to compare the use of the Vektor Computational ECG Mapping System (vMap®) with pulmonary vein isolation (PVI), to using PVI alone, to treat Atrial Fibrillation (AF) in adults. Participants will have a 50/50 or 1 out of 2 chance of being placed in the treatment or control arm. The control arm of the study involves PVI alone for ablation procedure(s). The treatment arm involves the use of vMap mapping in addition to PVI to plan ablation procedure(s).
NCT07349121
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.
NCT07445789
The SMART-VERAPAF is a study that investigates the effects of different heart rate-lowering medications in patients with paroxysmal atrial fibrillation (AF). This heart rhythm disorder is associated with a large number of emergency room visits and hospitalizations for cardioversions and ablations. In this study, patients with symptomatic paroxysmal AF are randomized to treatment with heart rate reduction using verapamil or metoprolol, both licensed for this indication. In addition, in a subset of patients, the effect of centrally guided self-care using smartwatch data will be evaluated. The hypothesis is that both verapamil and guided self-care will lead to better heart rate control and fewer cardioversions and pulmonary vein ablations in patients with paroxysmal AF. This will also result in fewer hospital admissions, outpatient visits, and costs, as well as improved quality of life.
NCT07441759
Cardiovascular diseases are the leading cause of mortality from treatable conditions in the European Union and the second from preventable causes, with a standardized mortality rate of 257.8 deaths per 100,000 inhabitants. In 2022, more than 1.11 million deaths in individuals under 75 years could have been avoided. Atrial fibrillation (AF) and major adverse cardiovascular events (MACE) are highly prevalent in the elderly and generate substantial healthcare costs. AF significantly increases the risk of MACE and is projected to rise markedly in the coming decades. In Europe, AF prevalence is expected to increase 2.5-fold over the next 50 years, with a lifetime risk of 1 in 3-5 individuals after age 55. AF-related strokes are projected to increase by 34%, and ischemic strokes in individuals over 80 are expected to triple between 2016 and 2060. Additionally, a 27% increase is anticipated among stroke survivors who subsequently develop AF or related conditions. AF substantially impacts morbidity, mortality, and disease progression, and early detection and treatment are crucial to prevent severe outcomes. European action plans (2018-2030) and the 2024 ESC/ESO guidelines emphasize early detection and management of AF in primary care. Although several AF prediction models exist, their integration into clinical practice remains challenging. AF represents a clinical continuum, with thrombotic risk present even before arrhythmia onset. High-risk patients for AF also show a high incidence of MACE, defined as a composite of myocardial infarction, stroke, systemic embolic events, and cardiovascular death. The proposed strategy involves developing and clinically validating an Artificial Intelligence (AI) model to improve early thrombotic risk prediction in patients at high risk of AF, using MACE as the primary outcome. This model aims to outperform the traditional CHA₂DS₂-VASc score by incorporating both classical and emerging clinical factors. The estimated timeline from clinical validation to commercialization is approximately 48 months. AI-based prediction is expected to enable personalized treatment, reduce the incidence of MACE, hospitalizations, and disability, and improve cost-effectiveness, ultimately decreasing the social and economic burden of AF and stroke in Europe.
NCT07439731
1. Study Purpose The primary aim of this research was to systematically describe and characterize a novel, thrombus-mimicking artifact observed during Intracardiac Echocardiography (ICE), termed the "Floating Lotus" sign. The study sought to define its imaging features, determine its prevalence, and identify the clinical factors that predict its occurrence. This was driven by the clinical need to prevent the misdiagnosis of this pseudo-thrombus as a true Left Atrial Appendage (LAA) thrombus, which could lead to unnecessary procedure cancellations or anticoagulation changes. 2. Study Population The study population consisted of 172 consecutive patients with non-valvular atrial fibrillation (AF) who underwent ICE-guided catheter ablation and/or left atrial appendage occlusion (LAAO) between January and December 2024 across three tertiary medical centers. Patients with confirmed intracardiac thrombus, significant valvular heart disease, or prior cardiac surgery were excluded. 3. Key Research Focus The key research focus was a multi-faceted investigation of the "Floating Lotus" sign: Incidence and Imaging Characterization: To quantify how common this sign is (found in 27.9% of patients) and meticulously describe its dynamic sonographic appearance-a mobile, echogenic mass within an anechoic space (pericardial effusion) that merges with the LAA wall upon catheter rotation. Identification of Clinical Predictors: To analyze which patient factors are associated with the sign. The study identified heart failure (LVEF \<55%) as the sole independent predictor through multivariable analysis. Clinical Correlation and Differentiation: To examine the sign's association with other clinical parameters (e.g., recent stroke, larger left atrial diameter) and emphasize the critical imaging maneuver (catheter rotation) that differentiates it from a true LAA thrombus, thereby highlighting its direct implications for procedural safety and decision-making.
NCT07430007
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is strongly associated with obesity and excess body fat. Lifestyle interventions, including exercise and dietary modification, may reduce AF burden, but long-term randomized controlled trial evidence with objective AF burden assessment and advanced cardiac imaging is limited. The MOVE-AF trial is a randomized controlled trial designed to evaluate whether a 12-month tailored exercise and dietary lifestyle intervention, compared with usual care, reduces atrial fibrillation burden and symptom severity and decreases cardiac and total body fat mass in overweight and obese adults with paroxysmal or persistent AF.
NCT07430956
This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. When this happens, blood cannot move smoothly through the heart; it can slow down or pool in one spot, which can lead to the formation of blood clots. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how effective and safe REGN7508 and REGN9933, individually, are in preventing ischemic stroke or systemic embolism in people with atrial fibrillation who cannot or may choose to not take blood thinners. The study is looking at several other research questions, including: * What side effects may happen from taking REGN7508 or REGN9933 * How well does REGN7508 or REGN9933 lower the risk of having an ischemic stroke and/or systemic embolism compared to the placebo * How well does REGN7508 or REGN9933 lower the risk of having a major health problem affecting heart and blood circulation compared to placebo * How well does REGN7508 or REGN9933 lower the risk of death compared to placebo * How much REGN7508 or REGN9933 is in the blood at different times * Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the study drugs less effective or could lead to side effects)
NCT07272902
This study is testing two different ways of treating atrial fibrillation (AF) in people who also have heart failure with mildly reduced or preserved heart function. Patients will randomly be assigned to either rhythm control using catheter ablation or rate control using medicines. The pilot phase will determine if a larger study can be successfully carried out to see which approach better improves survival, reduces hospitalizations, and enhances quality of life.
NCT07372716
The purpose of this study is to help find how safe current practices are when managing blood thinners in people with cancer who are having surgery or medical procedures. Investigators will also measure how often bleeding or clotting problems happen in this setting. The goal is to use this information to improve future care and reduce these risks for patients. This study will determine whether contemporary practices can be safely applied to cancer patients, and also evaluate the blood thinner level left over in patient's body at the time of surgery.
NCT07385417
The proposed pilot study is a prospective, randomized, single-center feasibility study, enrolling 200 patients with symptomatic paroxysmal AF. Per protocol, 100 patients will undergo a FARAPULSE electroporation PVI and 100 patients will receive standard AF medical treatment. Prior enrollment, all patients will be informed on the risk and benefits of the PVI procedure as well as the medical treatment. In addition, particular information on the rationale of the study, including a detailed risk/benefit analysis, will be provided to all patients.
NCT07380932
CABA-MiTRA-AFNET12 is a non-commercial, parallel-group, prospective, randomised, open, blinded endpoint assessment (PROBE), multi-centre, therapy strategy trial. The trial investigates patients with severe mitral valve regurgitation who have undergone transcatheter edge-to-edge mitral valve repair (M-TEER) and have concomitant atrial fibrillation (AF). The objective is to assess whether catheter ablation of AF is superior to standard-of-care treatment in patients after TEER in reduction of major adverse cardiovascular and cerebrovascular events (MACCE).
NCT06719921
This randomized controlled trial investigates the efficacy and safety of atrial fibrillation (AF) catheter ablation performed in non-fluoroscopic electrophysiology (EP) labs compared to conventional fluoroscopic digital subtraction angiography labs. The trial hypothesizes non-inferiority in outcomes, with the added benefits of simplified lab environment. Up to 724 participants aged 18-80 with paroxysmal or persistent AF will be enrolled across 10 centers. Participants will be randomized (1:1) to undergo catheter ablation in non-fluoroscopic or fluoroscopic labs, using pulmonary vein isolation (PVI) as the primary ablation strategy. The primary endpoints are freedom from AF recurrence at 12 months and composite safety outcomes related to procedure. Secondary endpoints mainly include procedure duration, recurrence during the initial 90 days, incidence of peri-procedural complications and changes in quality-of-life forms.
NCT07354737
The goal of this clinical trial is to learn if a voltage-guided stepwise pulmonary vein isolation (PVI) strategy can achieve effective PVI while potentially reducing lesion delivery, compared with conventional circumferential antral PVI, in adults (≥20 years) with paroxysmal or non-paroxysmal atrial fibrillation undergoing first-time catheter ablation. The main question(s) it aims to answer is/are: Is voltage-guided stepwise PVI non-inferior to conventional circumferential antral PVI for atrial tachyarrhythmia recurrence within 12 months after ablation? Does voltage-guided stepwise PVI differ from conventional circumferential antral PVI in procedural characteristics and safety outcomes, including endoscopically detected esophageal thermal injury and acute procedural complications? Researchers will compare the voltage-guided stepwise PVI arm to the conventional circumferential antral PVI arm to see if the stepwise approach maintains arrhythmia outcomes while changing lesion delivery requirements and safety outcomes. Participants will: Be randomized 1:1 to undergo catheter ablation with either voltage-guided stepwise PVI or conventional circumferential antral PVI. Undergo diagnostic esophagoscopy between post-procedure day 1 and day 3 to systematically assess for esophageal thermal injury. Complete follow-up evaluations at 3, 6, 9, and 12 months (and every 6 months thereafter), including 12-lead ECGs and 24- or 72-hour Holter monitoring.
NCT07360899
Atrial fibrillation is a common heart rhythm disorder that increases the risk of stroke. In patients with atrial fibrillation, blood clots most often form in a small structure of the heart called the left atrial appendage. If a blood clot travels from the heart to the brain, it can cause a stroke. Blood-thinning medications are commonly prescribed to reduce the risk of stroke in patients with atrial fibrillation. However, some patients cannot take these medications long-term because of bleeding risk, side effects, or other medical reasons. Closing the left atrial appendage is an alternative approach to reduce the risk of stroke by preventing blood from collecting in this area. When patients undergo cardiac surgery for another indication, closure of the left atrial appendage can be performed during the same operation. This study is designed to evaluate the safety and effectiveness of surgical closure of the left atrial appendage using a device called AtriLASH during cardiac surgery. AtriLASH is a surgical suture-based device intended to close the left atrial appendage. The study will assess whether the left atrial appendage can be safely and effectively closed using this method in patients with atrial fibrillation undergoing cardiac surgery. The information obtained from this study may help determine whether this approach can reduce the risk of stroke and potentially decrease the need for long-term use of blood-thinning medications in selected patients.
NCT07354230
The goal of this clinical trial is to learn if Rebamipide effective in gastroprotection in patients with atrial fibrillation who are treated with Direct Oral Anticoagulants (DOACs). Another point is to compare efficacy of Rebamipide and of its combination with Pantoprazole with efficacy of Pantoprazole only. Participants will: Take one of three variants of treatments for up to 24 weeks. Visits to the clinic wil take place for screening and then every 8 weeks.