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Arrhythmias, Cardiac clinical trials

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NCT ID: NCT03125382 Completed - Arrhythmia Clinical Trials

PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

PORTLink
Start date: April 2012
Phase: N/A
Study type: Interventional

Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)

NCT ID: NCT03094221 Completed - Cardiac Arrhythmias Clinical Trials

Clinical Utility and Validation of the Rhythmia Mapping System for the Treatment of Cardiac Arrhythmias

Start date: January 13, 2015
Phase: N/A
Study type: Observational

The purpose of this study is to compare two different types of three-dimensional electroanatomic mapping systems used for the treatment of cardiac arrhythmias. The systems will be compared in regards to its ability to successfully map and ablate a clinical arrhythmia, as well as the time invested in this activity.

NCT ID: NCT03079726 Completed - Clinical trials for Arrhythmias, Cardiac

Use of Device Data to Predict Frailty in Individuals

FRAILCIED
Start date: September 7, 2017
Phase:
Study type: Observational

This is an investigation to examine the correlation and predictive ability of activity measures obtained from cardiovascular implantable electrical devices.

NCT ID: NCT03067909 Completed - Clinical trials for Surgery--Complications

Antithrombotic Therapy in Patients Undergoing CIED Surgery - HEMATOMA NO MORE Registry

Start date: May 2016
Phase:
Study type: Observational [Patient Registry]

Hundreds of thousands patients undergo implantation or replacement of cardiac implantable electronic devices (CIEDs) annually in Europe, and up to 50% of these subjects receive antiplatelet agents or oral anticoagulants. Antithrombotic therapy increases the risk of developing pocket hematoma which in turn is associated with an increased risk of potentially fatal device-related infections when clinically significant. Aim of the registry is to retrospectively (pilot local registry in Tuscany) and prospectively (multicenter national registry in Italy) investigate the different strategies for the management of antithrombotic therapy and the related complication rates (1-month and 12-months) in patients undergoing CIED surgery in a real-world setting. The registry will also provide data on the economic impact of different management strategies and complications.

NCT ID: NCT03045068 Completed - Cardiac Surgery Clinical Trials

Platelet Transfusion During Neonatal Open Heart Surgery

CPB
Start date: April 11, 2017
Phase: Phase 4
Study type: Interventional

Hypothesis: Dilutional thrombocytopenia after cardiopulmonary bypass (CPB) is universal and administration of donor apheresis platelets just prior to termination of bypass will assist in early correction of coagulopathy, early hemostasis and lesser donor exposure of blood products after cardiac surgery. Background: What is the Problem? - Bleeding, Transfusion and Outcomes 1. Excessive bleeding after neonatal cardiac surgery has been independently associated with increased adverse events, morbidity and mortality.1,2 Bleeding after neonatal open-heart surgery has multiple etiologies such as immaturity of the building blocks of coagulation, effects of deep hypothermia, longer CPB times, altered flow states and dilutional state induced by being on CPB leading to low platelet count, low platelet function, low fibrinogen levels, altered fibrinogen polymerization, complement activation, etc.2,3 The strongest predictor of transfusion after cardiopulmonary bypass in children was deemed to be the CPB circuit volume and the effect of hemodilution.4 2. The dilutional coagulopathy after neonatal CPB requires intense damage control resuscitation with massive transfusion of platelets, packed red blood cells (PRBC), cryoprecipitate, fresh frozen plasma (FFP) and supplemental factor concentrates. In a previous study at this institution (IRB# HSC-MS-13-0647), we have shown that in neonates undergoing open-heart surgery there was a significant drop in platelet counts after bypass (71% change, baseline= 268 ± 90, Post CPB= 76 ± 27, 109/L). Associated with this drop , the average intraoperative transfusion load in neonates undergoing cardiac surgery with CPB at our institution constitutes of PRBC= 63± 43 ml/kg, FFP=51± 21 ml/kg, cryoprecipitate =12+6 ml/kg, platelets = 28 +16 ml/kg and cell-saver =27± 10 ml/kg. In addition 72% of these patients were exposed to a 3-factor prothrombin complex concentrate (Bebulin®). Although this "throw the kitchen sink" approach is effective in achieving hemostasis, it comes with significant effects on post CPB hemodynamics, constantly changing hematocrit, variable blood volume with inability to achieve steady state inotropic state affecting cardiac output, oxygen delivery and adding to pulmonary hypertension. Overall, having higher platelet counts at the time of weaning from cardiopulmonary bypass has distinct advantages of reducing transfusions and improving outcomes.

NCT ID: NCT03029169 Completed - Septic Shock Clinical Trials

Propafenone Versus Amiodarone in Septic Shock

PRASE
Start date: October 23, 2017
Phase: Phase 4
Study type: Interventional

Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom administered in intensive care due to a dose dependent toxicity published in case reports and unfavourable outcome reported in a few prospective trials done on cardiology patients. The papers on 1c class antiarrhythmics do not take into consideration a complex haemodynamic assessment using echocardiography. The authors have recently presented a retrospective study on SV arrhythmias in septic shock patients demonstrating favourable effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.

NCT ID: NCT03022487 Completed - Clinical trials for Ischemic Cardiomyopathy

Multicentre Investigation of Novel Electrocardiogram Risk Markers in Ventricular Arrhythmia Prediction

MINERVA
Start date: July 8, 2016
Phase:
Study type: Observational

This is a prospective open label single blinded multi-centre observational study involving a study group of patients already undergoing implantable cardioverter-defibrillator (ICD)(including Cardiac resynchronisation therapy device (CRT-D)) implant. A standard 30-minute electrophysiological (EP) cardiac stimulation protocol will be performed at the end of the ICD implant at baseline. This EP test will be performed whilst measuring a 12-lead ECG and will be correlated with event rates to establish their effectiveness in predicting arrhythmia risk. The minimum follow up period should be 18 months and maximum of 3 years, which is how long the study is funded for. This study is not randomised as all study patients will be receiving the EP study performed at baseline. A minimum of 440 patients will be recruited to document event data at standard clinical ICD follow up intervals - equating to a maximum of 6 visits. Blinding will be maintained at the core lab were the ECG analysis will be performed by a nominated researcher who will not have details of patient health status.

NCT ID: NCT03001206 Completed - Clinical trials for Acute Coronary Syndrome

The Use of the Master Caution System (MCS) for Continuous Monitoring and Detection of Dysrhythmias and Ischemic Events

Start date: January 2017
Phase:
Study type: Observational

The purpose of this study is to evaluate the effectiveness and usability of the Master Caution System for 12 leads continuous monitoring of ECG signal in the ICCU. The purpose of the study is to evaluate the effectiveness and usability of using Master Caution 12 leads Garment for stress test. The purpose of the study is to reassess the adequate size of the Master Caution Garment.

NCT ID: NCT02991716 Completed - Arrhythmia, Cardiac Clinical Trials

Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development

Start date: January 2016
Phase: N/A
Study type: Observational

Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using existing, approved ECG recording devices.

NCT ID: NCT02977104 Completed - Cardiac Arrhythmia Clinical Trials

Maestro Handheld Cardiac Monitor Validation

Start date: July 1, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate that the Maestro hand held heart monitor can accurately diagnose Atrial Fibrillation, atrial flutter or normal sinus rhythm in patients.