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Atrial Fibrillation clinical trials

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NCT ID: NCT02186704 Completed - Atrial Fibrillation Clinical Trials

Sensing Atrial High Rate Episodes With Implantable Cardioverter-Defibrillators Trial (The SENSE Trial)

SENSE
Start date: July 2014
Phase:
Study type: Observational

The primary aim of the "Sensing Atrial High Rate Episodes with DX System in Implantable Cardioverter Defibrillators Trial" (SENSE Trial) is to assess the efficacy of a implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting atrial high rate episodes. The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles will have a diagnostic yield comparable to that of a standard dual chamber ICD system and superior to that of a standard single chamber ICD system.

NCT ID: NCT02185027 Completed - Atrial Fibrillation Clinical Trials

Observatory of Invasive Procedures and Bleeding in Patients Treated With New Oral Anticoagulants

GIHP-NACO
Start date: June 2013
Phase:
Study type: Observational

The arrival on the market of direct oral factor Xa and factor IIa inhibitors (dabigatran (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) and others soon to come) raises novel questions among clinicians confronted with the emergency management of patients treated with these new drugs. It is likely that these new oral anticoagulants (NOACs) will eventually win a significant market share in the indications secondary prevention of venous thromboembolism and prevention of cardioembolic events in patients with nonvalvular atrial fibrillation, due to their net clinical benefit and their practicality of use compared with vitamin K antagonists (VKAs). However, despite the fact that NOACs reduce the incidence of intracranial bleeding by about half compared with VKAs, the risk remains significant; furthermore, in clinical trials, these drugs had little or no effect on reducing the incidence of major extracranial bleeding. In everyday practice, where the indication could be expanded to unselected populations and due to a potential for misuse, it is likely that the incidence of bleeding complications will be higher than that reported in clinical trials. Indeed, the numerous alerts emanating from regulatory agencies in various countries (US, Australia, etc.) bear witness to this, and should serve as a reminder that these anticoagulants have a real potential for bleeding complications and, in the absence of an antidote, there is no validated management strategy. Furthermore, as these drugs can be prescribed for months or years, patients may eventually be exposed to situations at high hemorrhagic risk, such as emergency surgery or invasive procedures, trauma, etc. Analysis of data from the trial : dabigatran versus warfarin in patients with atrial fibrillation (RE-LY) showed that during the two years of follow-up, approximately 25% of the patients underwent an invasive procedure, ranging from pacemaker insertion to major surgery. Thus, a large proportion of patients treated with NOACs are concerned by this issue. In anticipation of a gradually increasing influx of patients in a critical situation (active bleeding or need to rapidly secure hemostasis before an invasive procedure), it is urgent to define the conduct to adopt based on the experience gained from the earliest cases. This is the objective of the French-speaking GIHP-NACO observatory set up by the GIHP (French Working Group on Perioperative Hemostasis). For the moment, then, the management recommendations derive from expert opinions based on pharmacokinetic data and on the partial correction of NOAC-induced hypocoagulability by various nonspecific procoagulants (non-activated or activated prothrombin complex concentrates, recombinant factor VIIa). These procoagulants are currently used in an empirical manner to control bleeding, with as many successes as failures reported in the literature, and their benefit-risk ratio in these patients is therefore uncertain.

NCT ID: NCT02181361 Completed - Atrial Fibrillation Clinical Trials

Hirudin Plus Aspirin in the Secondary Prevention of Cardioembolic Stroke Due to Nonvalvular Atrial Fibrillation

Start date: June 2014
Phase:
Study type: Observational

To investigate the efficacy and safety of hirudin plus aspirin therapy compared with warfarin in the secondary prevention of cardioembolic stroke due to nonvalvular atrial fibrillation.

NCT ID: NCT02180542 Completed - Stroke Clinical Trials

Atrial Fibrillation and Premature Atrial Complexes in Patients With Ischemic Stroke.

Pacific
Start date: March 2012
Phase: N/A
Study type: Observational

The purpose of this study is to improve secondary prevention of ischemic stroke patients by 1. Estimating prevalence and the prognostic significance of frequent premature atrial complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial fibrillation. 2. Characterize ischemic stroke patients by 1. Echocardiographic characteristics 2. Biochemical markers 3. Plaque composition in the carotid arteries - in order to improve risk stratification.

NCT ID: NCT02175043 Completed - Atrial Fibrillation Clinical Trials

Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation

Start date: June 3, 2014
Phase: N/A
Study type: Interventional

1. Purpose of the study 1) To compare clinical outcome, procedure time, complication rate of persistent atrial fibrillation patients between conventional additional linear ablation and additional complex fractionated atrial electrogram targeted catheter ablation. 2. Scientific evidence of the study 1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality. 2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed. 3. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy. 4. However, there are no consensus for proper ablation strategy in longstanding persistent atrial fibrillation. 5. additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial. 6. Therefore, we will compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation. 3. Methods 1. Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation. 2. there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study. 4. study contents 1. to evaluate superior ablation strategy in longstanding persistent atrial fibrillation - compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation. both strategies are conventional ablation strategies being performed world-wide. 2. compare complex fractionated atrial electrogram before and after linear ablation.

NCT ID: NCT02171364 Completed - Atrial Fibrillation Clinical Trials

Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study

Start date: August 2014
Phase: N/A
Study type: Interventional

Radiofrequency catheter ablation is highly effective in the treatment of patients with persistent atrial fibrillation. In order to decrease the recurrence rate after catheter ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial computer model. The investigators will test with five different set of ablation methods and find successful methods for a specific patient. Then, this result will be compared to empirical catheter ablation result by randomly controlled trial.

NCT ID: NCT02169622 Completed - Atrial Fibrillation Clinical Trials

CABG REVEAL: Atrial Fibrillation After Coronary Artery Bypass Graft

Start date: June 18, 2013
Phase:
Study type: Observational

Atrial Fibrillation is an abnormal heart rhythm that can occur after coronary heart bypass graft operations. How often this happens and what other problems occur for a person after these operations needs to be better understood. This study uses a device called the Reveal XT, a small device that records heart rhythms to track a patient's heart rhythms after the bypass surgery. The device is implanted at the time the bypass graft is made. The information that is gathered for this study will help physicians to provide better treatment and follow-up of the patients under their care.

NCT ID: NCT02168972 Completed - Atrial Fibrillation Clinical Trials

Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF)

GLOBAL-AF
Start date: November 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe® Mapping and Ablation System for treating patients with atrial fibrillation.

NCT ID: NCT02167165 Completed - Atrial Fibrillation Clinical Trials

Role of SNP and DIGOXIN Response in Atrial Fibrillation Patients

Start date: July 2013
Phase:
Study type: Observational

This study tested the hypothesis that response to digoxin is modulated by single Nucleotid Polymorphism (SNP): - Multi Drug Resistance (MDR1) gene haplotypes and Solute carrier organic anion transporter family member 1B3 (SLCO1B3) gene Polymorphism and their role in the response to treatement. - Aldosterone synthase (CYP11B2) gene and sodium channel, voltage-gated, type V alpha subunit gene (SCN5A) correlated with atrial fibrillation and their roles in response to digoxin.

NCT ID: NCT02164864 Completed - Atrial Fibrillation Clinical Trials

Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

Start date: July 22, 2014
Phase: Phase 3
Study type: Interventional

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome). The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.