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Arrhythmias, Cardiac clinical trials

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NCT ID: NCT02559011 Completed - Clinical trials for Aortic Valve Stenosis

Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device

Reveal
Start date: March 2016
Phase:
Study type: Observational

Transcatheter aortic valve implantation (TAVI) has emerged as a valuable minimal-invasive treatment option in patients with symptomatic severe aortic valve (AV) stenosis at prohibitive or increased risk for conventional open-heart surgery. Recent randomized clinical trials reported a large treatment effect of TAVI over medical treatment among inoperable patients and similar or superior outcomes compared with surgical aortic valve replacement in high to intermediate risk patients. However, atrio-ventricular conduction disturbances and arrhythmias (in particular atrial fibrillation) before, during or after TAVI remain a matter of concern as they have important consequences. The objective of this study is to investigate the incidence, nature and prognostic significance of AV-conduction disturbances and arrhythmias among patients with severe, symptomatic aortic stenosis undergoing TAVI before, during and after the procedure using a small implantable cardiac monitoring system (ICM; Medtronic REVEAL LinQTM). One hundred patients will be enrolled in this study. Prior to TAVI (at least 4 weeks), at the time of preprocedural hemodynamic and anatomical assessment, the ICM will be inserted under the skin of the chest under local anesthesia. The device will be interrogated just prior to readmission for TAVI and thereafter at 1, 3, 6, and 12 months of follow-up. The incidence of symptomatic as well as silent brady- and tachyarrhythmias will be recorded, and its impact on medical and device treatment as well as clinical outcomes analyzed. The present study will provide information about the actual incidence and impact of symptomatic and silent arrhythmias and AV-conduction disturbances among patients with severe, symptomatic aortic stenosis undergoing TAVI. Specifically, the study estimate the burden of arrhythmias before TAVI and to accurately determine the incidence of new onset atrial fibrillation and complete AV-block within 12 months after the procedure. Identifying patients at risk for AV- conduction abnormalities, atrial fibrillation (AF), and non-sustained or sustained ventricular arrhythmias may guide future preventive measures, medical treatment and improve patients outcomes after TAVI.

NCT ID: NCT02550340 Completed - Clinical trials for Arrhythmias, Cardiac

Munich Study for Beer Related ECG Change Workup

Munich BREW
Start date: September 2015
Phase: N/A
Study type: Observational [Patient Registry]

The study aims to determine if acute recreational alcohol intake is associated with the occurence of ECG changes and arrhythmias.

NCT ID: NCT02541175 Completed - Atrial Fibrillation Clinical Trials

Multi-Channel Esophageal ECG Signal Classification

MC-EECG
Start date: October 2015
Phase: N/A
Study type: Observational

This study is designed to prove new methods to enable the automated analysis of esophageal electrocardiography (eECG) signals in long-term measurements as well as the detection of atrial fibrillation. The investigators hypothesis is that eECG signals allow the reliable atrial and ventricular ECG signal distinction and the detection of atrial fibrillation. Therefore 14 patients with arrhythmias and 6 cardiac healthy subjects are asked to take part in this study. On each subject an esophageal ECG and a simultaneous standard surface ECG will be taken for about half an hour. Patient undergoing a cardiac catheter ablation during their current hospitalization will be further asked to allow access to the invasively obtained measurements (i.e. atrial potential map) to further improve the understanding of the eECG signals.

NCT ID: NCT02481102 Completed - Clinical trials for Arrhythmias, Cardiac

EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry

EASYER
Start date: June 30, 2015
Phase:
Study type: Observational [Patient Registry]

The objective of the Registry is to provide post market clinical outcome and potential health economics data and confirm the continued safety of the EpiAccess system.

NCT ID: NCT02466633 Completed - Clinical trials for Arrhythmias, Cardiac

Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias

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

To increase the potential for timely detection and treatment of cardiac events, hospitals have implemented a number of different cardio-respiratory monitoring methods for at-risk patients. The goal of this study is to compare different monitoring methods to determine the most efficient method to monitor hospitalized patients - the method that will lead to the quickest response to critical heart rhythms. The investigators will then test the efficiency of this monitoring method by implementing it in a new patient care unit.

NCT ID: NCT02428140 Completed - Stroke Clinical Trials

Post-Embolic Rhythm Detection With Implantable Versus External Monitoring

PERDIEM
Start date: July 2015
Phase: N/A
Study type: Interventional

The overall aim of this trial is to determine the most cost effective approach to diagnose paroxysmal atrial fibrillation (PAF) following transient ischemic attack (TIA) and stroke. A summary of the rationale for this study is as follows: 1. Recently completed randomized trials of cardiac monitoring following stroke have established that PAF is more common than previously recognized in cryptogenic stroke. 2. The majority of TIA/stroke patients will have at least one potential stroke mechanism identified by the time etiologic investigations completed. 3. Detecting PAF in patients with strokes with known causes (eg. lacunar and large vessel atherosclerosis) is clinically important since appropriate anticoagulation for AF reduces stroke recurrence in all patients with prior TIA/stroke not just cryptogenic strokes. 4. There are competing technologies for evaluating cardiac rhythm and diagnosing AF but no cost effectiveness data 5. The rates of PAF in strokes with known causes (SKC) have not been well characterized. PER-DIEM is a pilot study to compare two different cardiac monitoring technologies as first-line investigations to detect PAF in patients with recent stroke and TIA. The study will also assess whether a pivotal trial is feasible and warranted. The principal research questions to be addressed in this study will be: 1. Whether implantable loop recorder (ILR) plus remote monitoring will diagnose more paroxysmal AF / atrial flutter and provide a better assessment of the total burden of AF resulting in a greater proportion of patients started on an OAC versus the external loop recorder (ELR) strategy. 2. What is the relative cost-effectiveness as a first-line investigation of long-term implantable ECG (ILR) coupled with remote monitoring for 12 months compared to external event-triggered ECG loop recorder (ELR) for 30 days in the diagnosis clinically actionable AF in following TIA/stroke. 2) What is the feasibility, patient compliance, diagnostic accuracy and rates of AF detection (>30 seconds) of ILR compared to the ELR strategies.

NCT ID: NCT02415686 Completed - Epilepsy Clinical Trials

Cardiac Arrhythmias in Dravet Syndrome

Start date: June 2015
Phase:
Study type: Observational

SUMMARY Rationale: People with Dravet Syndrome (DS), a rare epilepsy syndrome, have a high risk of Sudden Unexpected Death in Epilepsy (SUDEP). Mouse models indicated that the responsible sodium channel mutation (SCN1A) not only alters cortical excitability but also increases the propensity to arrhythmias. Little is known yet about the prevalence of seizure-induced arrhythmias in human DS subjects. Objective: To assess the prevalence of cardiac arrhythmias in DS and to compare the prevalence of cardiac arrhythmias between DS subjects and subjects with other types of epilepsy. Study design: Observational study. Study population: Subjects with Dravet syndrome and a known pathogenic SCN1A mutation, seizure frequency ≥ 1/week (all seizure types except for absences or myoclonias), age ≥ 6 years and no signs of self-harm. Each case will be matched to two historical controls (age +/- 5 years) from the EEG databases of the participating centres. Only those controls with two or more recorded seizures will be matched to the cases. Intervention: Main study parameters/endpoints: Ictal asystole Ictal bradycardia Ictal QT-shortening/lengthening Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation does not carry risks. The sensor is wearable and miniaturised, thus minimising discomfort. If this nevertheless may occur, the study can be terminated. This study provides specific tools to investigate the seizure-related heart rate response. Subjects may thus benefit from participation by identification of otherwise unknown arrhythmias. The rationale of the study (the high SUDEP risk and the evidence in animal studies for arrhythmic cause of sudden death) specifically applies to DS, a rare epileptic syndrome including minors and incapacitated persons. The investigators believe that the lack of risks, the potential diagnostic benefit, the minimal intervention with novel and wearable sensors and the possibility to terminate the study in case of discomfort, justifies the study in this patient group.

NCT ID: NCT02350608 Completed - Blood Pressure Clinical Trials

Pulse Waveform and ECG Analysis in Postoperative Cardiac Surgical Patients

Start date: March 2015
Phase: N/A
Study type: Observational

Observational study of 20 postoperative cardiac surgery patients. On admission to the ICU the patients will receive a noninvasive monitor recording arterial pulse waveform and ECG. The monitoring will continue to the ward for two days. The data will be compared with the routine monitoring methods.

NCT ID: NCT02341768 Completed - Arrythmia Clinical Trials

Clinical and Device Functional Assessment of Real World ICD Patients

CARAT
Start date: June 2015
Phase:
Study type: Observational

The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve life by terminating life-threatening arrhythmias (VT/VF). The treatment options vary in terms of techniques and medical devices, based on the patient's condition. It is extremely important in the clinical practice to identify which patients' subgroup benefits the most from the ICD therapy, which comorbidity has a major impact on the patients' prognosis, or which pre-intra-post procedural behaviors provoke less complications, and affect the patient's outcome (including prolonged or unwanted hospitalizations).

NCT ID: NCT02332096 Completed - Atrial Fibrillation Clinical Trials

Screening for Sleep Apnea in Patients Undergoing Atrial Fibrillation Ablation

Start date: June 2015
Phase:
Study type: Observational

Diagnosis and treatment of sleep apnea with continuous positive airway pressure (CPAP) therapy has been shown to decrease arrhythmia recurrence in patients with AF following ablation. However, patients with AF undergoing ablation are not routinely screened for sleep apnea, despite an estimated sleep apnea prevalence of 25% in the general population, and perhaps higher among patients with AF. Home sleep testing is frequently used for evaluation of sleep apnea.