Unstable Angina Clinical Trial
Official title:
CardioSenseSystem Compared to Philips Telemetry System Regarding Efficacy and Safety in the Monitoring of ECG
This is a prospective, controlled, comparative clinical trial of a new ECG monitoring system CardioSenseSystem prior CE marking. The aim of the study is to demonstrate that the CardioSenseSystem's cable-free ECG monitoring system (investigational device) is equivalent or better than traditional and accepted industry standard for cable-based ECG monitoring system (control device). In this study accepted industry standard is Philips Intellivue. In order to investigate this, the study will measure ECG monitoring interruptions, management time and alarm performance. The study population will consist of sixty (60) adult subjects requiring ECG and that are fulfilling the eligibility criteria for study participation. The subjects will be using both the investigational device and the control device simultaneous for measuring data loss, management time and alarm function up to 24 hours.
A prospective, controlled and comparative clinical trial before CE marking of a new ECG
monitoring system CardioSenseSystem. The study population will consist of sixty (60) adult
subjects requiring ECG and that are fulfilling the eligibility criteria for study
participation. The subjects will be monitored by both the investigational device and the
control device for measuring data loss, management time and alarm function up to 24 hours.
The duration of the study is estimated to 4 months.
CardioSenseSystem is designed to provide wireless high-quality ECG monitoring. The system
developed by Novosense AB consists of three components: the CardioPatch, the Novosense Base
Station and the Back-End System. The CardioPatch is a wireless sensor capable to record and
transmit ECG data. The CardioPatch send ECG data to the Novosense Base Station, which is the
receiving unit. The Back-End System is used for presentation, storage and processing of ECG
information. The CardioPatch sensor is applied to the body with an adhesive in the same way
as a traditional ECG electrode. In contrast, the CardioPatch is a fully integrated unit
containing electrodes, ECG amplifier and a radio transmitter. Novosense's wireless ECG
sensors, CardioPatch, transmits the ECG signal 24 hours to the Novosense Base Station
receiver.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05563701 -
Evaluation of the LVivo Image Quality Scoring (IQS)
|
||
Completed |
NCT04097912 -
Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
|
||
Withdrawn |
NCT03906812 -
A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain
|
N/A | |
Completed |
NCT01826552 -
Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent
|
Phase 4 | |
Completed |
NCT01709669 -
The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease
|
N/A | |
Completed |
NCT01688648 -
Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
|
N/A | |
Completed |
NCT01171404 -
Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge
|
N/A | |
Completed |
NCT01167582 -
Myocardial Ischemia and Transfusion Pilot
|
Phase 3 | |
Completed |
NCT01020383 -
Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients
|
Phase 2 | |
Completed |
NCT00449826 -
Risk Stratification of Non ST Elevation ACS With Computed Tomographic Angiography (REACT)
|
N/A | |
Terminated |
NCT00355992 -
The Ischemia Modified Albumin In Diagnosing Ischemic New Events
|
N/A | |
Completed |
NCT00263263 -
RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.
|
Phase 2 | |
Active, not recruiting |
NCT04929496 -
Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study
|
N/A | |
Completed |
NCT03103620 -
Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
|
||
Completed |
NCT04648306 -
Restore EF Observational Study
|
||
Not yet recruiting |
NCT03266289 -
Evaluation of Short Term Outcome of Different Bifurcation Stenting Techniques at Assuit University Cath. Lab
|
N/A | |
Not yet recruiting |
NCT04403048 -
Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID
|
N/A | |
Recruiting |
NCT02748603 -
Appropriateness of Coronary Angioplasty in PAtients With isCHEmic Heart Disease
|
N/A | |
Completed |
NCT01774838 -
Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
|
Phase 3 | |
Completed |
NCT01974492 -
Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting
|
N/A |