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Arrhythmias, Cardiac clinical trials

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NCT ID: NCT02807948 Completed - Cardiac Arrhythmia Clinical Trials

SJM MRI Diagnostic Imaging Registry (IDE)

Start date: June 2016
Phase: N/A
Study type: Interventional

This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan.

NCT ID: NCT02793895 Terminated - Atrial Fibrillation Clinical Trials

Detection of Atrial Fibrillation After Cardiac Surgery

SEARCH-AF
Start date: February 24, 2017
Phase: N/A
Study type: Interventional

The aim of the SEARCH-AF trial is to evaluate a novel diagnostic tool for detecting post-operative atrial fibrillation or flutter (POAF/AFL) in cardiac surgical subjects during the early, sub-acute post-operative period. The population includes cardiac surgical subjects who have either developed or are at risk for developing new onset POAF/AFL and who are at risk for stroke, as determined by their CHA2DS2-VASC (congestive heart failure, hypertension, age ≥75 years (2 points), diabetes mellitus, previous stroke/transient ischemic attack (TIA) (2 points), vascular disease, age 65-74 years, sex class (female)) score. These subjects must not have had a history of AF/AFL before cardiac surgery. The intervention group will undergo up to 30 days of continuous cardiac rhythm monitoring with an adhesive, patch-based monitor (Medtronic SEEQ™ mobile cardiac telemetry system or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device). The control group will receive usual care, which does not involve planned cardiac rhythm testing within the first 30 days after study randomization. The primary outcome is documentation of sustained atrial fibrillation or flutter within the first 30 days after randomization. In addition, subjects in both groups will undergo 14 days of continuous cardiac rhythm monitoring with the Medtronic SEEQ™ mobile cardiac telemetry system or the CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device at 6±1 months after their index cardiac surgery.

NCT ID: NCT02791880 Active, not recruiting - Stroke Clinical Trials

Acute Kidney Injury Genomics and Biomarkers in TAVR Study

Start date: October 25, 2016
Phase:
Study type: Observational

In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly utilized alternative procedure for replacing a stenotic aortic valve. This study collects clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR and to identify key clinical and procedural predictors of AKI. This study seeks to identify blood and urine biomarkers that can be used for early detection of AKI around the time of the procedure. The study seeks to assess for novel genetic variants associated with development of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and biomarkers that are associated with adverse cardiovascular events after TAVR and to further explore how these events may inter-relate with acute kidney injury.

NCT ID: NCT02783898 Completed - Atrial Fibrillation Clinical Trials

The IPED (Investigation of Palpitations in the ED) Study

IPED
Start date: June 2016
Phase: N/A
Study type: Interventional

Palpitations (noticeable pounding, fluttering or irregular heart beat) and pre-syncope (near blackout) are common ED problems sometimes due to an abnormal cardiac rhythm. This is difficult to diagnose as examination and electrocardiogram (ECG) are commonly normal and symptoms have usually resolved by the time the patient arrives in the ED. Diagnosing an abnormal heart rhythm as the cause of symptoms rests on capturing it on an ECG and patients are usually discharged with advice to return to the ED again for a 12-lead ECG should symptoms recur. The investigators will recruit 242 adult participants to either study or control arms. All study arm participants will be given an AliveCor Heart Monitor and trained in the use of the device. Control arm participants will receive standard care only. Both groups will be followed-up at 90 days. The investigators believe a smart phone based event recorder will allow better and earlier diagnosis in patients with a compatible smart phone or tablet, and revolutionise ED care in this area.

NCT ID: NCT02779400 Completed - Healthy Clinical Trials

Assessment of a Diagnostic Medical Device for the INR (International Normalized Ratio) Measurement

HEMOPTICS2
Start date: May 23, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).

NCT ID: NCT02761343 Completed - Clinical trials for Ventricular Tachycardia

MRI Assessment of Arrythmia Ablation Lesions

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

This study will evaluate the feasibility of visualization and characterization of arrhythmia ablation lesions by MRI immediately following standard ablation techniques. The appearance of the ablation lesion will be correlated with clinical outcomes and risk of arrhythmia recurrence.

NCT ID: NCT02757430 Completed - Cardiac Arrhythmias Clinical Trials

EnSite Precision™ 2.0 Registry

Start date: August 30, 2016
Phase:
Study type: Observational [Patient Registry]

The objective of this registry is to assess and characterize the use and performance of the EnSite Precision™ Cardiac Mapping System and the EnSite Precision™ Software V2.0 in a variety of electrophysiological (EP) procedures and clinical settings. This registry will assess the clinical performance of the system in a controlled, real-world environment after commercial release. Up to 500 subjects will be enrolled in up to 50 sites worldwide. Data will be collected at enrollment/baseline, procedure and pre-discharge. There is no long-term follow-up required for this registry. The anticipated registry enrollment is about 6-7 months.

NCT ID: NCT02751021 Completed - Sleep Apnea Clinical Trials

Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction

SAPAAD
Start date: June 22, 2016
Phase: N/A
Study type: Interventional

Little is known about potential relationships between sleep apnea, plasma aldosterone and diastolic dysfunction which is a very frequent finding among patients requiring permanent cardiac pacing. Sleep apnea is often under diagnosed by clinical examination. Confirmation tests are expensive and access is limited. A specific algorithm available in a recent pacemaker allows assessing breathing variations using minute ventilation sensor, with a good agreement between the respiratory disturbance index and polysomnography results for the diagnosis of severe sleep apnea. The purpose of the study is to examine the diagnostic accuracy of a new pacemaker algorithm for the diagnosis of obstructive sleep apnea in patients presenting with diastolic dysfunction. The investigators also aim to highlight a correlation between plasma aldosterone levels and the severity of sleep apnea, with a reversal effect of ventilation therapy in this specific population.

NCT ID: NCT02746471 Completed - Clinical trials for Arrhythmias, Cardiac

Reveal LINQ Registry

Start date: April 2014
Phase:
Study type: Observational

The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.

NCT ID: NCT02743520 Completed - Atrial Fibrillation Clinical Trials

Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)

ADIOS
Start date: March 6, 2017
Phase: N/A
Study type: Interventional

The purpose of this research study is to learn about arrhythmia detection in obstructive sleep apnea (OSA). For several years patients with OSA have an increased likelihood of having irregular heartbeats. This study will determine how often patients with OSA have irregular heartbeats. This study will also define which OSA patients are most likely to have irregular heartbeats. The participant is being asked to be in the study because the participant has been diagnosed with obstructive sleep apnea (OSA).