Cardiac Disease Clinical Trial
Official title:
Open Clinical Investigation to Assess Performance of a Temporary Epicardial Pace Wire With Integrated Sensor for Continuous Postoperative Monitoring of Myocardial Function After Heart Surgery Compared to Ultrasound
Verified date | January 2024 |
Source | Cardiaccs AS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Transesophageal echocardiography is used to monitor cardiac wall motion at various time points during open-heart surgery. After surgery, the measurements are made at various time points by transthoracic echocardiography. The CS1 system enables continuous, direct measurement of cardiac wall motion. This is achieved through use of temporary pacemaker wires incorporating a motion detector called an accelerometer. Use of TMEs during and after open-heart surgery is part of the normal clinical routine. Continuous monitoring of cardiac wall motion during and after surgery can quickly highlight the need for medical intervention with cardiac drugs and allow very early detection of potentially serious complications leading to abnormal cardiac wall motion. Cardiac wall motion activity registered by the CS1 system and echocardiography at specific time points during and after surgery will be analyzed to see how well they compare.
Status | Enrolling by invitation |
Enrollment | 38 |
Est. completion date | March 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Patients with heart disease requiring surgery 2. Above 18 years 3. Patients suitable for study participation without safety concerns based on the Investigator's evaluation of medical history and physical examination. 4. The patient must be able to understand the aims and objectives of the trial, willing and able to comply with all study related procedures 5. The patient must be willing and able to provide written informed consent prior to participation in the clinical investigation 6. The patient agrees to abstain from enrollment in any other clinical investigation for the duration of the study Exclusion Criteria: 1. Esophageal disease 2. Atrial fibrillation 3. Pregnancy |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Cardiaccs AS | European Commission |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Peak Systolic Velocity (PSV) after increasing heart rate by 25 percent | Correlation between relative changes in PSVs measured by CS1 and echocardiography | After surgery: before extubation, while patient is in the intensive care unit (ICU) | |
Primary | Change from Baseline PSV after increasing heart rate by 25 percent | Correlation between relative changes in PSVs measured by CS1 and echocardiography | After surgery: after extubation and removal of drains, before patient is transferred from ICU to general ward | |
Secondary | Adverse Events | Incidence of non-serious and serious adverse events rated for causality | Up to 30 days after surgery | |
Secondary | Adverse Device Effects | Incidence of non-serious and serious adverse device-related effects | Up to removal of device at a maximum of 7 days after surgery | |
Secondary | Device Deficiencies | Incidence of device deficiencies | Up to removal of device at a maximum of 7 days after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05490303 -
HeartGuide: Preliminary Study
|
N/A | |
Completed |
NCT05070819 -
Atrial Natriuretic Peptide in Assessing Fluid Status
|
N/A | |
Not yet recruiting |
NCT04511403 -
Prevalence of Oral Mucosal Alterations In a Sample of Egyptian Patients With Cardiovascular Diseases: A Hospital- Based Cross-Sectional Study
|
||
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Completed |
NCT02697760 -
The CZT Dynamic Myocardial Perfusion Imaging
|
||
Terminated |
NCT05157568 -
Pilot Randomized Clinical Trial of Live-streamed Cardiovascular Rehabilitation
|
N/A | |
Not yet recruiting |
NCT04160845 -
Non-invasive Forehead Skin Temperature in Cardiac Surgery
|
||
Completed |
NCT04500912 -
Comparison of the Supraflex Cruz 60 Micron Versus the Ultimaster Tansei 80 Micron in HBR PCI Population
|
N/A | |
Not yet recruiting |
NCT06438159 -
Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation.
|
N/A | |
Recruiting |
NCT06154473 -
Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit
|
||
Not yet recruiting |
NCT05877755 -
Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging
|
N/A | |
Completed |
NCT03394859 -
Electronic Medical Records and Genomics (eMERGE) Phase III
|
||
Recruiting |
NCT05055830 -
Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)
|
||
Recruiting |
NCT04374799 -
Heparin vs Placebo for Cardiac Catheterization
|
Phase 3 | |
Completed |
NCT03174106 -
Longterm Follow-up of Cardiac Patients With an Smartphone-Application
|
N/A | |
Recruiting |
NCT05531253 -
Respired Gases in Patients Post Cardiac Surgery
|
||
Recruiting |
NCT04609228 -
Cardiac Surgery Outcomes in Blood-transfusion Acceptors and no Acceptors
|
||
Recruiting |
NCT06149143 -
Cardiac Performance System Data Collection Study - Minnesota
|
||
Recruiting |
NCT05725655 -
Hot Water Immersion After Myocardial Infarction
|
N/A | |
Recruiting |
NCT06073509 -
Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer : Watch Your HeaRT
|