Arrhythmias, Cardiac Clinical Trial
Official title:
Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert.
cutaneous ECG electrodes positioned near the sternum and on the midaxillary line, at the approximate positions of the ISSD sense electrodes, are used to record patients undergoing Defibrillation Threshold (DFT) studies or Electrophysiology (EP) studies of different types. Two separate copies of the recordings undergo parallel and separate analysis: one is sent to an expert Electrophysiologist for determination and classification of arrhythmia events of at least 5 seconds and at least 170 beats per minute. the other is fed to the ISSD detection algorithm, with a low cutoff rate of 170 beats per minute. the results are compared to establish the accuracy of the detection algorithm and the rate of false detection / classification of arrhythmia events. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03079726 -
Use of Device Data to Predict Frailty in Individuals
|
||
| Recruiting |
NCT06014996 -
Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.
|
N/A | |
| Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
| Completed |
NCT05404789 -
Tolerance of Centrifuge-induced Acceleration in Subjects With Diabetes Mellitus and Cardiac Arrhythmia
|
N/A | |
| Recruiting |
NCT04554160 -
Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
|
||
| Recruiting |
NCT04471584 -
Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors
|
N/A | |
| Recruiting |
NCT02906189 -
Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
|
N/A | |
| Completed |
NCT02466633 -
Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias
|
N/A | |
| Completed |
NCT02550340 -
Munich Study for Beer Related ECG Change Workup
|
N/A | |
| Completed |
NCT01871090 -
Remote Device Interrogation In The Emergency Department
|
N/A | |
| Completed |
NCT04884100 -
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening
|
N/A | |
| Withdrawn |
NCT04556240 -
RECORD-VP: Real-time Evaluation of Cardiac Outpatient Recording Device With VitalPatch RTM
|
||
| Active, not recruiting |
NCT05481359 -
AF-FLOW Registry: This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation.
|
||
| Recruiting |
NCT05047835 -
Comparison of Prone Position and Standard Electrocardiogram in COVID-19 Patients
|
||
| Not yet recruiting |
NCT05957315 -
Mobile Cardiac Outpatient Telemetry for Unexplained Syncope
|
N/A | |
| Not yet recruiting |
NCT05974306 -
Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System
|
N/A | |
| Completed |
NCT06260670 -
FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation
|
N/A | |
| Active, not recruiting |
NCT04876963 -
HOLT-ED: Holter-monitoring in End-stage Renal Disease
|
||
| Completed |
NCT04943354 -
Associations of Combinations of Single-nucleotide Polymorphisms in Women With Premature Ovarian Failure
|
N/A | |
| Recruiting |
NCT03857711 -
Randomized Clinical Trial PULVAB (Prophylactic Pulmonary Veins Ablation)
|
N/A |