Validation of a non-invasive pressure measurement device during cardiac catheterization
Validation of a Magnetic Sensor for the Non-invasive Measurement of Jugular Venous and Radial Arterial Pressure in Patients During Cardiac Catheterization
This study is testing a new non-invasive device that measures blood pressure in patients with complex heart conditions to see if it can help detect heart problems earlier than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05943275 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a new non-invasive magnetic sensor designed to measure jugular venous and radial arterial pressures in patients with complex congenital heart disease and chronic right heart failure. The goal is to improve the early detection of right ventricular dysfunction, which is often challenging due to the unique anatomical and hemodynamic characteristics of these conditions. By utilizing this innovative technology, the study seeks to provide a more sensitive alternative to traditional imaging methods like ultrasound and MRI. Participants will be those undergoing right-sided catheterization, and the study will assess the effectiveness of the sensor in real-time clinical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for right-sided catheterization.
Not a fit: Patients with metal implants near the sensor application area or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of right heart dysfunction in patients with complex congenital heart disease.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using non-invasive methods for hemodynamic monitoring, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient who receives a right-sided catheterization * Age ≥ 18 years * Informed consent Exclusion Criteria: * Patient with a metal implant near the area of use of the device * Pregnant or breastfeeding woman * Patient unwilling or unable to sign consent: patient under guardianship or conservatorship, mentally retarded, dementia, language barrier * Patient not affiliated to a social security system * Patient under court protection
Where this trial is running
Montpellier
- CHU de Montpellier Département de Cardiologie Hôpital Arnaud de Villeneuve — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Quentin DELBAERE, MD
- Email: q-delbaere@chu-montpellier.fr
- Phone: 0467332501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.