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Atrial Flutter clinical trials

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NCT ID: NCT02355106 Completed - Atrial Flutter Clinical Trials

Prospective, Multicenter, Investigation of the Adagio Cryoablation System in Subjects With Atrial Flutter

Start date: January 2015
Phase: N/A
Study type: Interventional

The objective of the study is to demonstrate the safety and feasibility of the Adagio System in subjects with Atrial Flutter.

NCT ID: NCT02344901 Completed - Clinical trials for Atrial Fibrillation and Flutter

ReAl-life Multicentre Survey Evaluating Stroke Prevention Strategies (RAMSES)

RAMSES
Start date: February 2015
Phase: N/A
Study type: Observational [Patient Registry]

The aim of this study is to evaluate the present status of stroke prevention strategies in patients with non-valvular atrial fibrillation (NVAF). Vitamin K antagonists (VKAs) have been the only available oral anticoagulant therapy for decades. Recently novel oral anticoagulants have emerged as an alternative for VKAs. This study is planned to evaluate the epidemiological characteristics, thromboembolic and bleeding risks, stroke prevention strategies and appropriateness of oral anticoagulant use in NVAF patients. Time in therapeutic range (TTR) is going to be calculated as the percent of visits in range (2-3) for warfarin patients. This is a national multicenter observational study in which Turkey is divided into seven regions. A proportional number of patients to the population of every region is planned to be included.

NCT ID: NCT02307188 Completed - Clinical trials for Atrial Fibrillation or Atrial Flutter

Multipolar Mapping and Atrial Arrhythmias

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

This clinical investigation utilizes the Constellation Full Contact Mapping catheter in the left and right atria to explore atrial signal characteristics that can guide atrial fibrillation and atrial flutter ablation procedures more effectively.

NCT ID: NCT02273609 Completed - Clinical trials for Atrial Fibrillation and Flutter

INR Control and Atrial Fibrillation in Primary Care in Spain (PAULA)

PAULA
Start date: February 2014
Phase: N/A
Study type: Observational

The primary objective of this study was to determine rates of INR control of patients with nonvalvular AF daily attended in primary care in Spain. PAULA is an observational retrospective/cross-sectional and multicenter study. Patients aged ≥18 years old, with nonvalvular AF, treated with VKAs for at least one year in primary care were included in the study. To be included, at least 80% of INR values during the past 12 months should be available. Before inclusion, patients provided written consent. Clinical data (biodemographic data, comorbidities, treatments, and thromboembolic/bleeding risk) were recorded from the clinical history of patients at the moment of inclusion. INR values were taken from the previous 12 months of inclusion. Poor INR control was considered when percent time in therapeutic INR range (TTR) was <65% (calculated by Rosendaal method) or <60% by direct method (proportion of INR values). A total of 1,524 patients have been included in the study.

NCT ID: NCT02268799 Completed - Atrial Fibrillation Clinical Trials

High Sensitivity Troponin T Levels Following DC Cardioversion for Atrial Fibrillation / Atrial Flutter

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

The purpose of this study is to determine if there is a rise in serum high sensitivity troponin T (a marker for heart muscle injury) following a direct current cardioversion (shock therapy) used for patients with atrial fibrillation. This will help us determine if direct current cardioversion results in damage to the heart muscles in a sufficient amount to cause a rise in high sensitivity troponin T.

NCT ID: NCT02257060 Completed - Clinical trials for Cavotricuspid Isthmus Dependent Right Atrial Flutter

LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter

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

The Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.

NCT ID: NCT02214069 Completed - Atrial Fibrillation Clinical Trials

Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation

iRead
Start date: August 2014
Phase: N/A
Study type: Observational

The purpose of this study is to examine whether patients can use the AliveCor case to record their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm

NCT ID: NCT02213666 Completed - Atrial Fibrillation Clinical Trials

Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography

ICE-TEE
Start date: January 2012
Phase: Phase 4
Study type: Interventional

The presence of intracardiac thrombi and their propensity for systemic embolism is a major concern in patients with atrial fibrillation (AF) and atrial flutter (AFL) undergoing cardioversion and ablation procedures. Transesophageal echocardiography (TEE) is the clinical gold standard imaging modality for visualization of the right atrial appendage (RAA) and left atrial appendage (LAA) for detection of thrombi as well as risk factors associated with thrombus formation, including spontaneous echo contrast and low LAA velocity. However, TEE is a moderately invasive procedure that incurs additional risk, cost, and patient discomfort. In addition, thrombus detection via TEE may be ambiguous, and another tool capable of confirming uncertain TEE findings is desirable. This is particularly crucial in cases when adequate LAA imaging cannot be acquired or if TEE is clinically contraindicated, requiring alternative imaging modalities that can visualize these structures. Phased-array intracardiac echocardiography (ICE) provides high-imaging resolution and is routinely used during atrial fibrillation (AF) ablation procedures for transseptal puncture and periprocedural catheter visualization. A majority of imaging acquired during AF ablation is performed with the ICE catheter in the right atrium (RA). However, these standard views are often unable to provide sufficient visualization of the LAA structure due to the relatively long distance between the ICE catheter and LAA. Placement of the ICE catheter in the pulmonary artery (PA) provides improved visualization of the LAA over other locations by reducing the anatomic distance between the imaging catheter and structure of interest. Recent retrospective studies have confirmed improved assessment of the LAA with ICE imaging from the PA and equivocal sensitivity and specificity when compared with TEE for evaluation of LAA thrombus. However, these studies did not systematically evaluate the presence of SEC, flow velocity, the LAA dimensions, or the RAA. Although these studies support the use of ICE imaging from the PA to clarify or confirm TEE findings, a prospective and blinded study evaluating both the LAA and RAA in its entirety is required. We hypothesize that this prospective and blinded study will confirm ICE as non-inferior to TEE in the assessment of LAA and RAA structure and for the detection of thrombi.

NCT ID: NCT02089672 Completed - Arrhythmia Clinical Trials

RF Lesion Monitoring With 8mm IntellaTip MiFi XP

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

Abnormal heart rhythms or arrhythmias are often managed by a procedure in which a catheter is introduced into the heart. These catheters can then cauterize abnormally functioning portions of the heart muscle with the hope of returning the heart to a more effective rhythm. In the process of performing such a procedure, called a catheter ablation, an operator must be able to accurately sense electrical activity displayed on computer screens in different parts of the heart, provide sufficient localized energy to the abnormally behaving tissue (ideally without damaging uninvolved heart structures), and accurately reassess the electrical activity of the heart to ensure the spot in the heart has been cauterized. When sensing electrical activity of the heart, specialized catheters produce recordings on a computer screen known as electrograms (EGM). To produce this recording conventional catheters commonly use a positive and negative electrode, from which the difference between the two provides the EGM. The distance between the two electrodes varies from device to device. The greater the distance between them, the less accurate the measurement of local electrical activity becomes. This may result in poorly localized or excessive use of energy that could be damaging to normal heart structures or put the patient at risk for the return or development of additional arrhythmias. The IntellaTip MiFi catheter has been constructed with a specialized sensing tip that uses "microelectrodes" that are relatively close in proximity (<1 mm apart) with the hope of improving the sensing capability of the device. This study will analyze the signals obtained from this FDA-approved catheter in people undergoing a catheter ablation procedure. The study will examine signals after the procedure is finished and will not prolong or differ the process from a standard ablation procedure. The goal of this study is to determine the ability of the microelectrodes to distinguish ablated, or cauterized versus non-cauterized tissue.

NCT ID: NCT02088489 Completed - Atrial Flutter Clinical Trials

Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation

Cathena
Start date: November 2012
Phase: Phase 3
Study type: Interventional

Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with the same safety.