Active clinical trials for "Atrial Remodeling"

Several studies have suggested that the endogenous electric field and its polarity stimulate the proliferation and migration of epithelial cells and therefore promote wound healing. WoundEL® will reproduce the endogenous electrical current to stimulate all the factors contributing to healing. Electrostimulation of wounds, including the WoundEL® device, is a therapy listed but not yet reimbursed in France. The aim of this study is to show that the WoundEL® electrostimulation device is superior to the reference treatments recognized by the HAS.

The Pforzheim Tricuspid Valve Registry study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting in critically ill patients. The observational trial is a prospective, single arm, open-label, single-center, post market registry.

The aim of this prospective, monocentric, non-randomized trial is to investigate the impact of catheter ablation of atrial tachyarrhythmias on the ABC-stroke and ABC-bleeding risk scores. Participants planned for first catheter ablation for symptomatic atrial tachyarrrhythmias (atrial fibrillation, atrial flutter) will be enrolled. Serial blood samples will be collected before and 3, 6 and 12 months after catheter ablation to calculate the ABC scores as well as the traditional bleeding and stroke risks. Following catheter ablation, continuous rhythm monitoring will be achieved using an insertable monitor or an implanted atrial lead of a cardiac implantable electronic device. Additionally, heart rate monitoring via photoplethysmography using a smartwatch and/or smartphone is performed for a period of six months. Data are analyzed for differences in ABC scores before and after ablation in relation to possible AF/AT recurrences. Furthermore, we are going to compare the sensitivity and specificity of different follow-up modalities post ablation. The monitoring via ICM (gold standard) is compared to smartwatch-based monitoring alone, versus smartphone-based monitoring alone or a combination of both for AT/AF recurrences.

Heart failure with reduced left ventricular ejection fraction (HFrEF) is the most common form of chronic heart failure in subjects ≤ 75 years of age. Beta-blocker therapy greatly reduces mortality and improves ventricular function in HFrEF patients, but 30-40% of patients do not show improvement in ventricular function with beta blockade. An extensive gene signaling network downstream from the beta1-adrenergic receptor, the primary target of beta-blocker therapy is likely important for development and progression HFrEF. Pathologic changes in this gene signaling network are only reversed towards normal levels when ventricular function improves. One potential mechanism for failure to improve ventricular function in HFrEF patients unresponsive to beta blocker therapy is a lack of heart rate reduction. Ivabradine is an FDA-approved medication believed to have therapeutic benefit in HFrEF patients through reduction in heart rate independent of beta-blockade. Ivabradine has been shown to reduce the risk of hospitalization for worsening HF in patients with stable, symptomatic chronic heart failure with reduced EF (≤ 35%)in sinus rhythm with resting heart rate ≥ 70 bpm and who are on maximally tolerated doses of beta blockers or who have a contraindication to beta blockers. Given the high rate of mortality and hospitalization of HFrEF patients even with current therapies, there is a large unmet need for improving HFrEF therapy. The goals of this study are to test the hypothesis that heart rate reduction is an important antecedent for improvement in ventricular function, and to identify components of the beta1-adrenergic receptor gene signaling network responsible for improvement in ventricular function caused by heart rate reduction.

This study explored the influence of radiofrequency catheter ablation and cryoballoon ablation on atrial electrical remodeling in patients with atrial fibrillation,the relationship between atrial electrical remodeling and structural remodeling,and which indicators are associated with atrial recurrence after catheter ablation.

Atrial fibrillation (AF) is the most common arrhythmia present in 1% of population under 60 years of age and reaching up to 15% at 80 years. AF is associated with reduced quality of life, increased morbidity, mortality and health economic costs. Presentation of AF differs substantially among patients ranging from self-limiting short episodes (paroxysmal AF), longstanding episodes (persistent AF) where direct current (DC) cardioversion is needed, to chronic atrial fibrillation. Treatment of AF is individually tailored in accordance to symptoms, type of AF and thromboembolic risk. The standard treatment of symptomatic persistent AF is DC-cardioversion preceded by anticoagulant treatment with Warfarin. According to guidelines DC-cardioversion can be performed when anticoagulation treatment has been in therapeutic range for at least 4 weeks. However introduction of Pradaxa (Dabigatran) has enabled an earlier DC cardioversion, reducing time to cardioversion to a 3 week period. During anticoagulation treatment persistence of AF contributes to left atrial remodeling and increases in inflammatory and neurohumoral biomarkers. The prolonged duration of AF and the remodeling of the left atrium increase the risk of AF recurrence after DC-cardioversion. Early cardioversion of patients with persistent AF is possible if preceded by transesophageal echocardiography (TEE). The TEE guided DC- cardioversion, as demonstrated in the ACUTE study, is a safe and efficient alternative to conventional treatment. This treatment regime is not routinely used in clinical practice. The aim of this study is to compare early DC-cardioversion (within 72 hours) to conventional treatment (Pradaxa prior to DC-cardioversion). 140 patients with persistent AF will be randomized to early cardioversion preceded by TEE in accordance with guidelines or conventional treatment with Pradaxa for 4 weeks prior to DC-cardioversion. The investigators will determine the outcome in the two groups regarding: Left atrial function and size assessed by left atrial strain, left atrial ejection fraction and left atrial volume. Inflammatory and neurohumoral biomarkers including ANP, BNP,IL6 and CRP. Time to recurrence of AF (AF documented by ECG or Holter monitoring) Comprehensive transthoracic echocardiography, 12 lead ECG, biomarkers and Holter monitoring will be performed at the time of randomization, 4 weeks, 3 month and 6 month post DC-cardioversion. Furthermore all patients will be followed for symptomatic AF recurrence for a period of one year. AF recurrence will be documented by 12 lead ECG.

Dapagliflozin reduces the risk of de novo heart failure (HF) in diabetics and, recently, it has shown to improve the prognosis of patients with HF and reduced left ventricular ejection fraction (HFrEF), by preventing HF decompensations and cardiovascular death. The benefit showed by dapagliflozin in HFrEF was irrespective of diabetes status and glycemic control, which raises the question of which mechanisms are underlying apart from SGLT2 inhibition. In addition, the impact of dapagliflozin on cardiac remodeling parameters, as assessed by echocardiography and biomarkers, is not well established. In particular, left atrial (LA) remodeling represents a relevant prognostic marker, which has received a greater attention in the last years in the context of new imaging tools. The purpose of this study is to assess the effect of dapagliflozin therapy over a period of 6 months in LA remodeling parameters, including geometry and function, as well as complementary biomarkers in patients with chronic HF regardless left ventricular ejection fraction (LVEF). This protocol will allow for evaluation of improved understanding of the interplay between dapagliflozin and LA function , biomarkers, remodeling and outcomes, and will carefully assess such relationships within important cohorts of subjects, such as those with reduced and preserved LVEF. This protocol will also generate a biorepository of well-handled and carefully considered biomarkers, which will allow a better understanding of dapagliflozin mechanism of action.

The purpose of this study is to study clinical factors and (blood) biomarkers related to progression of Atrial Fibrillation (AF) in patients diagnosed with self-terminating AF with special reference to hypercoagulability. All patients will be continuously monitored for their atrial rhythm to assess AF progression, either through an implantable loop recorder (Reveal LinQ) or via the atrial lead of a cardiac implantable electronic device (CIED), both in combination with the CareLink home monitoring system. Remote monitoring and interrogation will be installed and used on a daily basis.

Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases with progressive skeletal muscle weakness. The relevance of the peripherical neuromuscular electrical stimulation has never applied in the patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, investigator-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of an acute peripherical neuromuscular electrical stimulation session in patients with systemic autoimmune myopathies.

This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.