Active clinical trials for "Atrial Fibrillation"

While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches are used for substrate modification: linear lesions, ablation of complex fractionated atrial electrograms (CFAE) or a combination of both. The aim of this study is to determine whether there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE ablation in combination or not with linear lesions in patients with persistent AF.

Imaging Real Time within the Left atrial chamber Enhances safety and efficacy of Radiofrequency Ablation of Atrial Fibrillation

This is a PI-initiated study that aims to evaluate the efficacy of two different methods of paroxysmal atrial fibrillation (PAF) ablation. There are currently two strategies for PAF ablation that are routinely performed by electrophysiology clinicians: (1) circumferential pulmonary vein ablation (CPVA) and (2) segmental pulmonary vein isolation (SPVI). However, it is not known if one approach is better than the other. This randomized study will evaluate and compare the efficacy of CPVA versus SPVI in subjects undergoing ablation for paroxysmal atrial fibrillation only. Subjects will have a 50/50 chance of receiving either the CPVA or SPVI ablation method.

The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertension. To assess safety, the study will measure the occurrence of a composite safety endpoint and, to assess effectiveness, the study will measure freedom of chronic treatment failure through a minimum of six months of follow-up.

Background: The acute coronary syndrome (ACS) is a complication of coronary artery disease (CAD) and associated with increased mortality. Dual antiplatelet therapy of acetylsalicylic acid (ASA) with P2Y12 receptor antagonists such as clopidogrel is a cornerstone in the treatment of patients with advanced CAD. Due to delayed onset of action, intersubject variability or resistance to clopidogrel, different platelet aggregation inhibitors have been developed. Ticagrelor is a reversible P2Y12 receptor antagonist with superior efficacy compared to clopidogrel in the prevention of cardiovascular death in these patients. Atrial fibrillation (AF) is also associated with thromboembolic events and substantial mortality. Beside vitamin K antagonists (VKA, phenprocoumon) for stroke prevention in patients with AF, the direct factor Xa inhibitor apixaban has recently received approval for prophylactic treatment of patients with non-valvular AF. However, there is a lack of efficacy or safety data for the combined impact of antithrombotic drugs in patients requiring arterial and venous thromboembolic prophylaxis due to their underlying co-morbidities. One trial suggests treatment with VKA + clopidogrel without ASA as equal effective as antithrombotic triple therapy (with ASA) in this population. However, the effect in combination with novel oral anticoagulants has not been investigated so far. Study objectives: To evaluate the effect of ticagrelor + apixaban in combination with or without ASA at steady state on markers of coagulation activation and on thrombus size in an ex vivo perfusion chamber experiment. Additionally, plasma samples will be analysed for PK-data (ticagrelor & apixaban concentrations) Study design: A single-centre, prospective, sequential, controlled, analyst-blinded study in two groups. Subjects will receive ticagrelor + apixaban in combination with (study A) or without (study B) ASA. All IMPs will be administered at doses indicated for stroke prevention in AF (lower dose: 2.5mg due to ethical concerns) or ACS. Markers on thrombin generation and platelet activation will be studied in venous blood where coagulation is in resting state and in shed blood where the clotting system is activated in the microvasculature in vivo: prothrombin fragment 1+2 (F1+2), thrombin-anti-thrombin (TAT), β-thromboglobulin (β-TG). Additionally, inhibition of factor Xa activity and concentrations of ticagrelor and apixaban will be assessed in venous blood. Further, thrombus size of clots formed in an ex vivo perfusion chamber will be determined by measurement of D-Dimer and p-Selectin levels. Study population A total of 40 healthy, non-smoking and drug-free male volunteers will be enrolled (study A and B; n = 20 per group). Main outcome variables: β-TG in shed blood Additional outcome variables: F1+2 and TAT in shed blood fibrin formation (D-Dimer) and platelet deposition (p-Selectin) in an ex vivo perfusion chamber model of thrombosis β-TG, F1+2, TAT & inhibition of factor Xa in venous blood PT, aPTT and ACT in venous blood ticagrelor & apixaban plasma concentrations shed blood volume

The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join. Their doctors must plan to use shock to make their hearts beat normally. About 2200 people from different countries will join. They will have an equal chance of receiving either treatment. They are anticipated to be in the study for around 82 days. Tests will include physicals and finger-pricks. Participants will provide blood and urine samples.

The aim of this prospective randomized double-blind study was to compare the efficacy and safety of cryoballoon ablation with the RF approach in the treatment of paroxysmal AF after failed first radiofrequency ablation.

The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).

Background and study concept: Atrial fibrillation is the new global epidemic in cardiology. With improved survival from other cardiovascular diseases and longer living in general, the incidence and prevalence of AF rise dramatically in all developed countries with an estimated life time risk of one in four for all people above the age of 40 years. Similarly in Denmark, the prevalence is estimated to almost double within 2020. It is a fatal arrhythmia with doubled mortality compared to patients with normal sinus rhythm; this primarily caused by an increased risk of stroke and heart failure. In particular stroke is a feared complication with a 70% risk of fatal outcome or lasting handicaps and immense costs for each patient as well as in terms of health costs. Moreover, many AF patients experience a variety of symptoms and have markedly reduced quality of life. Opposed to heart failure patients and patients who have suffered from a myocardial infarction, AF patients are not offered any sort of rehabilitation when diagnosed. Pharmacological treatment of the arrhythmia is challenging. Most often, individual and careful risk evaluation including ultrasound of the heart is obligatory to choose optimal treatment strategy and prophylactic anticoagulation. In case a new anti-arrhythmic drug is started to restore and maintain sinus rhythm, hospitalization for at least two days with heart rhythm monitoring is required to detect any possible potentially dangerous or even fatal arrhythmia as a side effect to the treatment. Additionally, the first new oral anti-arrhythmic AF drug introduced for more than twenty-five years proved to be hazardous in a high-risk AF population and is now only used with strict precautions. To explore the role of alternative treatment strategies and to renew handling of cardiac arrhythmia, we have therefore set out to study the role of physical exercise in AF patients. Our specific study aims are to examine: The effect of physical exercise on AF burden The effect of physical exercise on the risk of cardiovascular hospitalization Method: Our study is an interventional, randomized exercise study. 60 patients older than 18 years with ECG-documented AF will be included if written informed consent is obtained. They will be randomized 1:1 to moderate-severe (80-85% of max capacity) or low intensity (50% of max capacity) training. Exclusion criteria are language barrier, illness inherent with an expected survival shorter than a year, other reasons preventing the patient from training, revealed serious cardiac disease during pre-tests, AF ablation within one year, permanent AF. Both groups are first participating in a nurse-led educational and care program. The program is built on two individual consultations and one team consultation with focus on education in AF. The patients will be thoroughly examined before randomization and after ended training period with special ultrasound of the heart, ECG-monitored test of maximal oxygen uptake on ergometer bicycle, 24 hours measurement of blood pressure and pulse, and blood samples. They will all be taught to use home ECG recorders, a new handheld device. The patients will send ECG's twice daily and if the experience cardiac symptoms for 5 months (during exercise and two months after). When randomized the patients will be divided in teams of ten and trained on separate teams, so the physiotherapist closely can guide the patients in training at the correct intensity level. Measurements: During and after physical exercise the burden of atrial fibrillation is measured by tele-ECG i.e. number of ECGs with atrial fibrillation divided by total number of ECGs. ECG reporting begins after four weeks of physical exercise and continues 2 months after last training session. Recording of hospitalization begins after randomization and continues one year after last training session. All hospitalizations caused by AF or related to the AF disease (relapse of AF, heart failure, stroke, new anti-arrhythmic medication, elective electrical cardioversion, complications to anticoagulation, pacemaker implantation) are recorded. Also, total days in hospital are registered. The AF population is growing on a global scale and the disease attracts immense interest on all international cardiology congresses. New knowledge of the effect of training for the general population as well as the effect in the setting of established disease could have paramount effect for prognosis, quality of life, and health costs as pharmacological treatment is AF still holds challenges.

Many risk factors contribute to the onset of atrial fibrillation. This study is specifically concerned with the effect of addressing these risk factors by cardiac rehabilitation on the risk of recurrence of atrial fibrillation following catheter ablation. A non-randomized, retrospective study was performed on patients treated with a catheter ablation for atrial fibrillation. The intervention group consisted of patients who chose to participate in the cardiac rehabilitation program. The control group only received standard care. The primary objective was to examine whether cardiac rehabilitation following the first ablation for atrial fibrillation resulted in a reduction of the time to or the risk of recurrence of atrial fibrillation or the need for a second ablation within 1 year after the first ablation. A Kaplan-Meier analysis was used to examine the primary objective. The secondary objectives of this study were to examine whether cardiac rehabilitation following the first ablation for atrial fibrillation had an effect on the evolution of the patients' BMI (a Mann-Whitney U test), the number of recurrences of atrial fibrillation (a Poisson regression) and the proportion of patients who need to continue treatment with antiarrhythmics 3 months following the first ablation (a chi-square test).