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Arrhythmias, Cardiac clinical trials

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NCT ID: NCT03309956 Completed - Clinical trials for Arrhythmias, Cardiac

Holter Versus Zio Patch Electrocardiographic Monitoring in Children

Start date: October 18, 2017
Phase: N/A
Study type: Interventional

This prospective study aims to compare the diagnostic yield, or ability to detect an arrhythmia, of the traditional Holter monitor versus the novel Zio patch monitor in pediatric patients referred for ambulatory electrocardiographic (ECG) monitoring. Children will wear both devices simultaneously for 48 hours and the incidence of clinically significant arrhythmias will be compared.

NCT ID: NCT03261063 Completed - Clinical trials for Arrhythmias, Cardiac

China Evera MRI® Study

Start date: October 12, 2017
Phase: N/A
Study type: Interventional

The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland China.

NCT ID: NCT03260244 Completed - Cardiac Arrhythmia Clinical Trials

EnSite Precision Observational Study

Start date: September 12, 2017
Phase:
Study type: Observational

This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study. This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world environment. This study will be conducted in patients who are indicated for a cardiac electrophysiological (EP) mapping and radio frequency ablation procedure using a three-dimensional system.

NCT ID: NCT03256812 Completed - Atrial Fibrillation Clinical Trials

ICT-based Monitoring for Arrhythmia Detection After AF Ablation

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

To compare the efficacy and stability of an ICT-based centralized clinical trial monitoring system against the efficacy and stability of an existing outpatient-based electrocardiogram (ECG) and Holter monitoring system for arrhythmia detection after atrial fibrillation ablation, and to test whether such continuous monitoring can better detect arrhythmia that is undetectable by existing methods and how this may affect treatment outcomes

NCT ID: NCT03243604 Completed - Clinical trials for Arrhythmias, Cardiac

cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study

ARBITRAGE
Start date: May 16, 2017
Phase:
Study type: Observational

Abiraterone associated with prednisone is used in prostate cancer. Abiraterone is a selective small-molecule inhibiting cytochrome P450 17A1 (CYP17A1), a key enzyme in androgen synthesis. CYP17A inhibition is also responsible for mineral corticosteroid related adverse events as hypokaliemia, fluid retention, and hypertension. Primary hyperaldosteronism is associated with cardiovascular toxicities such as atrial fibrillation and cardiac failure. Other androgen-deprivation therapies are not associated with increased mineral corticosteroid level. This study investigates reports of cardiovascular toxicities for treatment including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones) used in prostate cancer in the French pharmacovigilance database and in the EudraCT database.

NCT ID: NCT03204981 Completed - Clinical trials for Ventricular Arrythmia

Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias

Start date: October 17, 2017
Phase: N/A
Study type: Interventional

This study will examine the safety and efficacy of intramural needle ablation (INA) in the treatment of intramural ventricular arrhythmias in patients for whom standard RF ablation has been unsuccessful. The clinical team hypothesize that the increased current density and improved rates of transmural lesion creation seen with intramural needle ablation will lead to successful arrhythmia termination with minimal or no increased risk of complication.

NCT ID: NCT03195647 Completed - Cardiac Arrythmias Clinical Trials

Pilot Study for the Tight K Study

TightK
Start date: August 1, 2017
Phase: Phase 3
Study type: Interventional

The primary purpose of this pilot study will be feasibility of recruitment. However, in order to further inform a full randomised controlled trial (RCT), information on the incidence of atrial fibrillation (AF) and other arrhythmias, hospital length of stay, resource use and morbidity will be collected.

NCT ID: NCT03185832 Completed - Heart Failure Clinical Trials

Heart Failure and Sudden Cardiac Death Japan Registry

HINODE
Start date: July 21, 2017
Phase:
Study type: Observational

The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart failure (HF) events. These event rates will be compared with available published data mainly from Europe and the United States. Selected Subject Cohorts: 1. Selected subject cohort with criteria for SCD (without spontaneous prior ventricular sustained arrhythmia) and de novo Implantable Cardioverter-Defibrillator (ICD) device treatment. 2. Selected subject cohort with criteria for SCD and widely accepted standard cardiac resynchronization therapy (CRT) indication who received a de novo CRT-Defibrillator (CRT-D) device treatment. 3. Selected subject cohort who are clinically expected to require >40% right ventricular pacing with a left ventricular ejection fraction (LVEF) ≤50%, any determined New York Heart Association (NYHA) Class, and receiving pacemaker (PM) or CRT-Pacemaker (CRT-P) therapy despite previous device history (de novo, box changes, system revisions or upgrades). 4. Selected subject cohort with criteria for SCD fulfilling European Society of Cardiology (ESC) ICD or CRT-D therapy guidelines (2016) with an LVEF ≤35%, having 2 to 5 predefined SCD risk factors but do not have or had have a cardiac implanted defibrillator, CRT-D, PM, or CRT-P. The primary endpoint will report on the Composite rate of first appropriately treated ventricular arrhythmia (by anti-tachycardia pacing [ATP] or shock) or life-threatening symptoms associated to ventricular arrhythmia (defined as hemodynamic instability which requires treatment), whichever comes first under MADIT RIT Arm B or C programming conditions in a study population with a majority of Japanese subjects. This primary end point is assessed in the ICD/CRT-D implanted patient cohort. The all-cause mortality in subjects with a maximum of 3 risk factors (analyzed for MADIT II data) will be assessed in the Pacing (PM/CRT-P) patient cohort. The all-cause mortality will be assessed in the non-implanted subject cohort.

NCT ID: NCT03151278 Completed - Atrial Arrhythmia Clinical Trials

Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias

ZFA-RAA
Start date: January 2011
Phase: N/A
Study type: Interventional

This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach with conventional fluoroscopic approach as performing catheter ablation of right atrial arrhythmias.

NCT ID: NCT03150030 Completed - Clinical trials for Diabetes Mellitus, Type 2

Hypoglycaemia and Cardiac Arrhythmias in Type 2 Diabetes

HYPO-HEART
Start date: February 1, 2017
Phase:
Study type: Observational

Twenty-one patients with insulin-treated type 2 diabetes with diabetic complications will be recruited to Part 1 of the study, a three-hour combined hyper- and hypoglycaemic clamp, along with a control group of twenty-one individuals with normal glucose tolerance matched for age, gender, and body mass index. Patients with type 2 diabetes will be scheduled for a three-week run-in period with LR and CGM prior to participation in Part 1. Only patients with a well-functioning loop-recorder and who can comply with CGM will be included. Patients with type 2 diabetes will continue in part 2 of the study, a one year observational study employing CGM and LR and clinical examination after 1, 3, 6, 9, and 12 months and an extended observation period of 2 years employing LR and clinical examination.