Safety and Efficacy of Apixaban Versus Warfarin in Peritoneal Dialysis Patients With Non Valvular...
Atrial FibrillationPeritoneal Dialysis ComplicationSeveral well conducted randomized controlled trials have established the superiority or non-inferiority of oral anticoagulants (OACs) compared with vitamin K antagonists to treat non valvular atrial fibrillation (AF) for the prevention of thromboembolic events, as well as their safety profile (less major bleeding events with OACs) in the general population. Atrial fibrillation is associated with higher morbidity and mortality in patients with ESKD but there is a lack of randomized data in ESKD on hemodialysis and no data on peritoneal dialysis. Therefore, available evidence comes from retrospective observational studies that are notoriously unreliable to estimate treatment effects. In the population of patients with end stage renal disease (ESRD) on peritoneal dialysis, the investigators hypothesize that apixaban will be safer and as effective than warfarin for the management of non valvular AF, with a robust methodology: a randomized controlled trial. Individually, if the study hypothesis is confirmed during this protocol, the benefit could be direct in the experimental arm with less bleeding than in standard-of-care arm. Moreover, the risk of bleeding with apixaban will be reduced with the use of concordant dosing in peritoneal dialysis condition, known from APIDP1 study. Collectively, the investigators hope for an improvement in scientific knowledge that will allow us to optimize the treatment of atrial fibrillation in subjects on peritoneal dialysis, maybe with the help of pharmacodynamics indicator.
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
Heart Failure With Preserved Ejection FractionAtrial FibrillationThe goal of this clinical trial is to evaluate if a bariatric surgery strategy will improve clinical endpoints, cardiac parameters and functional status in patients with obesity (with BMI 32-40 kg/m2) and symptomatic HF with preserved or mildly reduced LVEF in combination with AF, as compared to standard of care. Patients will be randomized to either the Intervention group receiving bariatric surgery including an intensive pre- and postoperative treatment scheme or to the control group receiving standard of care.
The COLchicine and Atrial FIBrillation Trial
Atrial FibrillationThe purpose of this study to investigate the effects of colchicine on atrial fibrillation recurrence and vascular and cardiac function in patients with atrial fibrillation.
Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic...
Atrial FibrillationAtrial Fibrillation10 moreDemonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures. Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.
Quantitative Superior Vena Cava Isolation in Addition to Pulmonary Vein Isolation for Paroxysmal...
Atrial FibrillationPulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) has limited success. The superior vena cava (SVC) has been identified as one of the most common non-pulmonary vein triggers for PAF. It is estimated that SVC isolation (SVCI) could improve the clinical results for patients with PAF. However, results from previous studies about SVCI remain controversial. It is possible that safety concerns for SVCI outweigh its benefits and lead to inadequate ablation. To address this issue, the introduction of a quantitative ablation index (AI) for SVCI may provide a solution. The goal of this prospective, randomized controlled trial is to test the efficacy and safety of quantitative SVCI in addition to PVI in PAF. Participants with PAF will be randomly assigned to either PVI group or PVI+ quantitative SVCI group in a 1:1 ratio and will be followed up for 12 months. The main questions it aims to answer are: Evaluate the efficacy of PVI+SVCI guided by quantitative AI. Assess the safety of PVI+SVCI guided by quantitative AI. The primary end point is treatment success at 3 months after the index ablation. The secondary end points include treatment success at 12 months, and safety outcomes.
Short Term Anti-aRrhythmic Therapy for Post-Operative AF in Cardiac Surgery Patients Pilot Trial...
Atrial Fibrillation New OnsetThe START-POAF pilot study is a prospective, open-label two-arm, randomized controlled trial with blinded assessment of outcomes (PROBE). This pilot study will assess Atrial Fibrillation (AF) recurrence and burden in patients with new-onset AF following cardiac surgery.
Study of Interference Between Oral Anticoagulants and Heparin During Ablation of Atrial Fibrillation...
Atrial FibrillationAtrial TachycardiaCatheter ablation of atrial fibrillation (AF) or left atrial tachycardia (GAD) is usually performed in patients treated with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) that are increasingly used. In some cases, patients need to have an unfractionated heparin relay (UFH) for the procedure. There are no recommendations for adjusting UFH doses during an AOD/UFH relay. DOACs interfere with the biological assay of UFH which poses a problem of adaptation of UFH doses in pre- and intra-procedure. The aim of the study is to evaluate the interference of residual DOAC on the measurement of anticoagulant activity of UFH in pre- and intra-procedure of AF ablation or GAD.
Vagal Nerve Stimulation for the Treatment of Persistent AF
Atrial FibrillationThe goal of this clinical trial is to answer the question whether a transcutaneous stimulation of a certain nerve (Nervus vagus) with a dedicated device reduces the recurrence of the heart rhythm disorder atrial fibrillation. Participants will receive a dedicated nerval stimulation device and will treat themselves on a daily basis for at least an hour per day. Treatment will last for 3 months. Researchers will compare this group with a similar group that uses an ineffective device. Both researcher and patients will be blinded so they do not know which device they will be using.
Lesion Characteristics After Pulsed-Field Ablation in Patients With Atrial Fibrillation and a Left...
Atrial FibrillationPulmonary Vein Isolation1 moreThis study aims to investigate the lesion characteristics after pulmonary vein isolation using pulsed-field ablation in patients with atrial fibrillation and a common of the left pulmonary veins. The main question it aims to answer is: In which percentage of the patients will pulsed field ablation result in successful isolation of the left common ostium? Nineteen patients will be prospectively included in OLVG. All patients will be treated with pulsed-field ablation (routine care). After the ablation procedure, an electro-anatomical map will be created using the ablation catheter and a mapping system. This map will display the left atrium and the lesion in detail. After the procedure, three experienced operators are asked to draw a line around the LCO in the anatomical map where they would have ablated if conventional radiofrequency ablation was used. The distance between the drawn line and the ablation lesion will be measured at three predefined points. The lesion is considered successful if the mean distance is within ±10mm at all measurement points.
Abbott Atrial Fibrillation Post Approval Study
Atrial ArrhythmiaAtrium; Fibrillation1 moreThis post-approval study is designed to provide continued real-world clinical evidence to confirm the safety and long-term effectiveness of atrial fibrillation (AF) radiofrequency (RF) technologies (e.g. TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)) for the treatment of AF.