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Atrial Fibrillation clinical trials

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NCT ID: NCT03759912 Terminated - Atrial Fibrillation Clinical Trials

Ultra-High-Resolution Mapping Guided Partial Antral Ablation for AF

TAILOR
Start date: November 20, 2018
Phase:
Study type: Observational

The electrical isolation of the pulmonary veins (PVI) is the cornerstone of current ablation techniques for the treatment of atrial fibrillation (AF) because the PV is the most common trigger of AF. Wide bi-antral circumferential ablation (WACA) is more effective than segmental PV isolation in achieving freedom from total atrial tachyarrhythmia recurrence at long-term follow-up. Therefore, it is widely accepted as initial ablation strategy. However, the WACA technique requires a much larger number of ablation and higher energy to achieve complete isolation because of thick atrial myocardial sleeves with multiple muscle layers present in most of the PV antrum, which is less likely to achieve homogenous transmural lesions in the entire circumference with the currently available ablation technologies. Meanwhile, muscular discontinuities and abrupt changes of the fiber orientation in human PV-Left atrium (LA) junction are previously reported, and electrical PV isolation can usually be achieved without complete circumferential ablation. However, the current electroanatomical mapping (EAM) system has a limitation to understand the complex relationship of PV-LA junction mainly due to relatively low resolution. The Rhythmia mapping system (BostonScientific, Inc, Cambridge, MA) is a new system provides ultra-high-resolution EAM using a small basket array of 64 electrodes (IntellaMap Orion, Boston Scientific). Owing to better resolution, this new system capable of rapidly and accurately identify critical isthmuses and low-voltage regions of interest and also allows automatic acquisition and accurate annotation of the electrograms, without the need for manual correction. In this context, we hypothesized that rapid and precise identification of activation pattern of PV-LA junction by Rhythmia system could allow complete, durable electrical isolation of PVs without circumferential antral ablation.

NCT ID: NCT03757741 Completed - Atrial Fibrillation Clinical Trials

Inflammation, Fibrosis and Risk of Recurrence After Atrial Fibrillation Ablation

FIBRO-RISK
Start date: February 1, 2019
Phase:
Study type: Observational

FIBRO-RISK study aims to investigate the impact of inflammatory-mediated myocardial fibrosis on the risk of recurrence after successful ablation of atrial fibrillation. The level of systemic inflammation in the pre-ablation and immediate post-ablation period will be assessed on the basis of serum levels of inflammatory biomarkers (hs-CRP, matrix metalloproteases, interleukin-6), while the level of cardiac fibrosis will be determined based on MRI imaging associated with complex post-processing techniques for mapping myocardial fibrosis at the level of left atrium and left ventricle. At the same time, the amount of epicardial fat will serve as an indirect marker of localized inflammation and will be determined at different levels in the heart (surrounding left atrium, right atrium or the entire heart), while ventricular function will be assessed on the basis of serum levels of NT pro-BNP prior to the procedure. All these parameters will be investigated in patients with successful ablation of AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at 1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the following biomarkers will be determined: serum levels of inflammatory biomarkers and NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days. The primary endpoint of the study will be represented by the rate of AF recurrence at 1-year post ablation, documented by either ECG or Holter monitoring. The secondary endpoints of the study will be: - rate of re-hospitalization - rate of survival without relapse - rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)

NCT ID: NCT03753490 Active, not recruiting - Atrial Fibrillation Clinical Trials

ABC-Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - The ABC-AF Study

ABC-AF
Start date: November 25, 2018
Phase: N/A
Study type: Interventional

The primary study objective is to evaluate if personalized treatment by decision support, based on the biomarker-based risk prediction (ABC-scores) guided strategy, reduces the occurrence of the composite outcome of stroke or death in patients with atrial fibrillation. Approximately 6500 patients will be randomized 1:1 to ABC risk score guided therapy or standard care.

NCT ID: NCT03753139 Completed - Atrial Fibrillation Clinical Trials

Identification of Arrhythmias With One-time ECG

Start date: November 28, 2018
Phase:
Study type: Observational

In Western countries, every sixth person in their lifetime and 15,000 people in Finland have a new stroke each year. About every fourth stroke is based on cardiac embolism. Atrial fibrillation causes formation of thrombi in the left atrium with ensuing embolization in the cerebral and peripheral circulation. This study investigates the suitability of measurement techniques and new calculation methods used in sport/wellness technology for the screening and diagnosis of atrial fibrillation and other arrhythmias. New measurement technologies, the one-time ECG measurement and pulse wristband measurement, are studied for their characteristics, data quality and rhythm recognition. Identifying latent arrhythmias with new self-monitoring technologies can significantly reduce the number of strokes (the latent arrhythmias causes about 25% of strokes). The research will be accomplished in cooperation with the Kuopio University Hospital Emergency Department, the Heart Center, the Department of Applied Physics of the University of Eastern Finland and Heart2Save Ltd. The results of the research project will be published in the scientific journals of medicine and medical technology and will be presented at scientific conferences of the respective fields. The research results of the project can be utilized by all companies in the medical technology industry, in particular companies that produce ECG measuring instruments and companies that produce rhythm recognition software.

NCT ID: NCT03750435 Recruiting - Atrial Tachycardia Clinical Trials

Non-fluoroscopy Ablation of AF/AT

ZERO-AF
Start date: October 8, 2018
Phase: N/A
Study type: Interventional

Atrial fibrillation is the most common arrhythmia but can be treated by a catheter procedure where specialized wires (so-called catheters) are inserted in the left upper heart chamber. This requires crossing the wall between the right and left atrium with a long needle (a so-called transseptal puncture or TSP). This is typically done using x-ray guidance or echo to check if the needle is in the right position. The investigators developed a method to do the TSP without x-rays using a specialized needle that can be also shown as a little icon on the 3D electroanatomical mapping system (CARTO).3D mapping systems are routinely used to track the location of the catheters in cath labs worldwide, but the position of the needle was not tracked yet. The investigators seek to demonstrate that these procedures can be carried out safely, successfully and in a reproducible fashion without any radiation by taking advantage of "faking" the isolated tip of the needle as a catheter on the 3D mapping system. The results will be compared with historic procedures done by the same operator in the years 2012-2017.

NCT ID: NCT03749057 Recruiting - Cerebral Infarction Clinical Trials

Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation

ERSAF
Start date: November 20, 2018
Phase: Phase 4
Study type: Interventional

Anticoagulant treatment for non-valvular atrial fibrillation (AF) associated with cerebral infarction/ TIA is one of the recognized treatment of stroke prevention. The ACC/AHA and national guidelines for the management of anticoagulation recommend that most of AF patients with cerebral infarction or TIA should be administrated anticoagulant therapy within 14 days of symptom onset, while European guidelines recommend that the timing of the initiation of non-vitamin K antagonist oral anticoagulants (NOACs) for AF patients with cerebral infarction or TIA is association with stroke severity in light of the "1-3-6-12" principle. However, there are still many problems about the use of NOACs in ischemic stroke with AF. for example, it is unclear what time to begin NOACs as to difference in stroke severity, ages, comorbidity with hypertension, diabetes, heart failure, liver and kidney dysfunction and bleeding risks. Thus, the timing of the initiation of NOACs is yet to be further studied. Current urgent need is to develop a guideline-based specific regimen in which the benefit-risk factors are further balanced with a combination of NHISS, CHA2DS2-VASC and HAS-BLED score. Rivaroxaban, a direct coagulation factor Ⅹa inhibitor, blocks the formation of the clot. ROCKET-AF study has shown that the efficacy of rivaroxaban is not inferior to that of warfarin in AF patients on stroke prevention, and rivaroxaban has a significantly decreased bleeding risk compared with warfarin. Recent study indicates that early administration with rivaroxaban for AF patients within 14 days of onset does not significantly increase hemorrhagic transformation. However, the relevant clinical data of the efficacy and safety of early initiation of rivaroxaban in AF patients with cerebral infarction or TIA are lacking in China. Therefore, the investigators conduct a multicenter cohort study to investigate the safety of early rivaroxaban in the AF patient with cerebral infarction or TIA within 12 days of onset.

NCT ID: NCT03747263 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

Individualized Approach vs. Fixed Approach

INDI-FREEZE
Start date: December 1, 2018
Phase: N/A
Study type: Interventional

The purpose of the current study is to assess differences regarding the acute efficacy, safety, procedural duration, radiation exposure and long-term success of the novel AFA-Pro in combination of an individualized shortened ablation protocol containing a reduced freezing time to the standard approach of a fixed ablation protocol in patients with symptomatic PAF.

NCT ID: NCT03746301 Completed - Clinical trials for Non-valvular Atrial Fibrillation (NVAF)

Xarelto on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation

XARENAL
Start date: December 3, 2018
Phase:
Study type: Observational

The purpose of the study is to evaluate the safety and effectiveness of Xarelto in renally impaired patients with NVAF under routine practice conditions. The information collected in the XARENAL study will help to understand how renally impared patients with NVAF are treated in the real-world setting and what the outcome for the patients is under those conditions.

NCT ID: NCT03744936 Completed - Atrial Fibrillation Clinical Trials

Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)

(DA4AFib)
Start date: October 4, 2018
Phase: N/A
Study type: Interventional

To assist patients and clinicians to reach SDM about treatment options for patients with nonvalvular chronic Atrial Fibrillation screening the investigators aim to develop an evidence-based decision aid for use before the clinical encounters. Our goal is to promote evidence-based patient-centered care. Ideally, this care should reflect the research evidence about anticoagulation treatment. It should also reflect the values and preferences of the informed patient.

NCT ID: NCT03741491 Completed - Atrial Fibrillation Clinical Trials

Birkebeiner II Study

Start date: January 21, 2019
Phase:
Study type: Observational

Prolonged endurance exercise is associated with an elevated risk of atrial fibrillation (AF). The mechanisms governing this increased risk remains elusive. This study aim to detail the specific traits of elderly subjects with AF conducting endurance training by comparing elderly participators in the Birkebeiner cross country ski race(an indicator of prolonged endurance exercise practice) with and without AF to a not-so-trained control group.