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Active clinical trials for "Arrhythmias, Cardiac"

Results 601-610 of 689

3T MRI CIED Post-Approval Study

Cardiac Rhythm Disorder

The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).

Completed5 enrollment criteria

Ventricular Arrhythmias After Pulmonary Vein Isolation

Ventricular ArrhythmiasAtrial Fibrillation

The investigators study aimed to observe the occurrence of new premature ventricular complexes and other ventricular arrhythmias after pulmonary vein isolation.

Completed7 enrollment criteria

Cardiac Arrhythmias in Dravet Syndrome

Epilepsy

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: Not applicable 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.

Completed11 enrollment criteria

EnSite Precision 2.1 Feasibility Study

Arrhythmias

The objective is to demonstrate feasibility of new 'Magnetic Primary' catheter tracking algorithms within the Velocity Research Platform (VRP) by assessing the frequency of shift/drift during ablation compared to the current commercial EnSite Precision 2.0.1 The secondary objective is to evaluate catheter rendering in the VRP system.

Completed4 enrollment criteria

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

Device Related InfectionAntithrombotic Drugs3 more

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.

Completed4 enrollment criteria

Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY

Cardiac Arrhythmia

This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.

Completed5 enrollment criteria

Use of NAVA-catheter Positioning Screen to Identify Different Cardiac Arrhythmias

Cardiac Arrhythmia

The purpose of this study is to validate a novel method of diagnosing arrhythmias using the NAVA catheter-positioning screen in patients who have a NAVA catheter in place.

Completed2 enrollment criteria

True Continuous ECG Monitoring (TCEM Study)

Cardiac Arrhythmia

The purpose of this study is to compare short term (up to 48 hours) traditional cardiac rhythm monitoring using a standard ambulatory Holter monitor versus long term (up to 14 days), continuous ambulatory cardiac rhythm monitoring using a new device cleared by the FDA (Zio® Patch), iRhythm Technologies, Inc., San Francisco CA) in patients with suspected cardiac arrhythmias.

Completed9 enrollment criteria

An Arrhythmia Risk Stratification and Genetic Trial

CardiomyopathiesPrimary3 more

The prospective EUTrigTreat multi-center study is an observational, advanced diagnostics and genetic risk stratification trial in patients with standard indications for ICD treatment, with and without myocardial infarction in their history. Its aims are fourfold: 1) To accurately risk stratify a large cohort of implantable cardioverter-defibrillator (ICD) patients for ICD shock risk and mortality using traditional risk markers as well as genetic markers 2) To find a link between repolarization biomarkers and genetic markers of calcium metabolism. 3) To compare invasive and noninvasive electrophysiologic (EP) testing systematically 4) To assess temporal changes of typical noninvasive risk stratifiers and their prognostic implication. In five European academic clinical centers, 700 ICD patients are prospectively enrolled (optionally the number of enrolled patients may be expanded to 1000 patients). Comprehensive non-invasive risk stratifying ECG diagnostics including beat-to-beat variability of repolarization (BVR) are applied, and candidate genes associated with malignant arrhythmias are analyzed. Programmed electrical stimulation is performed to test for inducibility of malignant ventricular arrhythmias and BVR. In a subset of patients, electrophysiologic studies include recording of monophasic action potentials (MAP) from the right ventricle for assessment of restitution properties. Non-invasive risk stratifying ECG methods are repeated annually. Outcome (mortality, ICD shocks) will be assessed until September 2014.

Completed11 enrollment criteria

INSIGHT (R)XT. Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT

Atrial FibrillationCardiac Arrhythmias

To describe the clinical indications for Reveal XT in diagnosis and continuous monitoring of arrhythmia and to explore the clinical applications and outcome of arrhythmia monitoring on patient care.

Completed5 enrollment criteria
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