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Atrial Fibrillation clinical trials

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NCT ID: NCT02090543 Completed - Atrial Fibrillation Clinical Trials

BAY 59-7939 (Xarelto, SPAF), Non Interventional Studies

Start date: January 2014
Phase: N/A
Study type: Observational

According to recent guidelines, long-term anticoagulation is recommended for patients with atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more. Vitamin K antagonists(VAK) and novel oral anticoagulants such as rivaroxaban are current treatment options for AF patients with additional risk factors for stroke. Currently there are only limited information to what extend AF patients prefer one or the other treatment option based on patient relevant characteristics of novel oral anticoagulants vs. VKAs. It is also unknown which of the characteristics influences patient preference most and how this relates to a neutral comparator. Furthermore, an additional unknown factor is also how patient evaluate their current treatment and if this leads to differences among treatment with VKAs and rivaroxaban.

NCT ID: NCT02090075 Completed - Atrial Fibrillation Clinical Trials

Apixaban Versus Warfarin in the Evaluation of Progression of Atherosclerotic Calcification and Vulnerable Plaque

Start date: September 2014
Phase: Phase 4
Study type: Interventional

Vitamin K-antagonists (VKA) such as warfarin are the most widely used blood thinners for irregular heart beats like atrial fibrillation. Several lines of evidence indicate, however, that these agents also cause calcification of vessels (hardening of the vessels). Vascular calcification is one of the recently revealed side-effects of warfarin therapy. We will be randomizing 66 patients to either take warfarin or a new blood thinner that works without affecting vitamin k (apixaban). Patients will undergo blood testing and a CT angiogram (non-invasive angiogram) at the beginning of the study, and then be followed for one year with quarterly visits including blood tests and given either warfarin or vitamin K. After one year, they will undergo another CT angiogram and examination and blood tests and the effect of apixaban and warfarin are tested to look at plaque and changes over time. Patients will be consented in a private room and the risks and benefits will be explained. The risks include the CT angiogram and the possibility of either remaining on warfarin therapy for another year (standard of care) or taking a medicine that doesn't require monitoring (apixaban) for one year. The CT angiograms will require some contrast and some radiation dose, which will be minimized as much as possible. A cardiologist will be present during each CT angiogram to minimize risk and ensure patient safety.

NCT ID: NCT02088606 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Continued Access Protocol

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

A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.

NCT ID: NCT02082548 Completed - Atrial Fibrillation Clinical Trials

Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation

IMPACT-AF
Start date: June 2014
Phase: N/A
Study type: Interventional

To determine whether a comprehensive evaluation and customized multilevel educational interventions will increase the rate of use of oral anticoagulants and the adherence and persistence of use in patients with atrial fibrillation. Our hypothesis is that there will be differences in the use of oral anticoagulants and the persistence in patients between the control and interventional group. There will be a greater change in the use of oral anticoagulants over one year in the cohort in the intervention sites than the control sites. This will be due to two factors: greater initiation of oral anticoagulants among patients not treated at baseline and greater persistence of treatment for those on treatment at baseline

NCT ID: NCT02082366 Completed - Clinical trials for Atrial Fibrillation.

Microembolic Signals During CPVI (Circumferntial Pulmonary Vein Isolation) Assessed by TCD (Trans-cranial Doppler)

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

The aim of the investigators study is to analyze the incidence of MES by TCD performed during AF ablation with the nMARQ and to compare is with the incidence of MES using a conventional irrigated ablation catheter. Objective: To investigate the incidence of MES on TCD during AF ablation with the nMARQ catheter compared to a conventional irrigated ablation catheter. Following inclusion, patients will be randomized into 2 equal different treatment groups: PVI with traditional irrigated RF catheter versus PVI using the nMARQ catheter. In all patients, anticoagulation therapy with warfarin is discontinued five-days before the procedure and low molecular weight heparin is initiated at that time. A CT-scan of the left atrium is performed and imported into the Carto 3 mapping system. The ablation procedure is conducted under general anesthesia or conscious sedation. A decapolar catheter is positioned in the coronary sinus and a quadripolar catheter is positioned at the His bundle level through the right femoral vein. Two 8F sheaths are introduced into the left atrium with double trans-septal puncture performed under fluoroscopic, trans-esophageal echocardiographic or intracardiac echocardiography guidance. Upon completion of the first trans-septal puncture, intravenous heparin is administered to maintain an activated clotting time of 350 seconds throughout the procedure. A variable Lasso circular mapping catheter is introduced through the SL1 sheath into each pulmonary vein for electrical mapping. After the second trans-septal puncture, a Navistar Thermocool 3.5mm irrigated ablation catheter or an nMARQ circular irrigated ablation catheter are introduced into the left atrium. Of note, in case of use the nMARQ catheter, the second SL-1 sheath is replaced by a steerable 8F agilis sheath after the second trans-septal puncture. Each of the 4 PVs are imaged by selective angiograms. The left atrium geometry is created using the nMARQ catheter or the Navistar catheter and then merged with the pre-acquired CT scan of the left atrium and PVs. Identification of true MESs will be possible using an event detector system, in addition to determining whether the MESs are attributed to a solid or to a gaseous embolus. Total MES counts will be collected and evaluated separately during different stages of the procedure.

NCT ID: NCT02081807 Completed - Atrial Fibrillation Clinical Trials

Sequential Expansion of Comparative Effectiveness of Anticoagulants

Start date: March 7, 2014
Phase:
Study type: Observational

This cohort study is the sequential expansion of the comparative effectiveness study of oral anticoagulants and plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.

NCT ID: NCT02080858 Completed - Atrial Fibrillation Clinical Trials

Triple vs. Dual Therapy

Start date: May 2014
Phase: Phase 1
Study type: Interventional

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

NCT ID: NCT02074566 Completed - Atrial Fibrillation Clinical Trials

Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study

Start date: August 14, 2014
Phase: N/A
Study type: Interventional

Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.The objective of the study is to assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.

NCT ID: NCT02073396 Completed - Clinical trials for Coronary Artery Disease

Assessment of Thrombotic Status in Patients at Risk of Cardiovascular Thrombosis

Start date: January 2013
Phase:
Study type: Observational

Patients with coronary artery disease (CAD) and atrial fibrillation (AF) are at increased risk of stroke and heart attack. Such events are usually caused by increased stickiness of the blood causing a blood clot to block the artery (thrombus) in the heart or the brain. The aim of this study is to assess the stickiness of the blood (global thrombotic status) in patients with CAD and AF at baseline and after clinical stabilisation to see how disease state and clinical treatments affect the stickiness of the blood (thrombotic status). This will be a single centre study. Patients diagnosed with CAD or AF will have a blood sample taken at baseline and after clinical stabilisation. Blood stickiness will be tested with the Global Thrombosis Test. The results will be evaluated to assess the effect of disease process and clinical state on blood stickiness to gain further understanding of this condition and form the basis for future studies aimed at identifying patients who are at high risk of future cardiovascular events, based on increased blood stickiness.

NCT ID: NCT02072434 Completed - Atrial Fibrillation Clinical Trials

Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)

ENSURE-AF
Start date: March 25, 2014
Phase: Phase 3
Study type: Interventional

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.