Magnetic Sensor Validation of Hemodynamic Non-invasive Measurements Pressure During Cardiac Catheterization

NCT05943275 | Unknown

• 2 other identifiers: RECHMPL21_05952022-A00775-38
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Follow-up of patients with complex congenital heart disease (CHD) usually involves ultrasound imaging or even MRI or CT scans of the heart and stress testing. But these examinations can be challenged in terms of their sensitivity. Thus, the development of non-invasive jugular venous and radial arterial pressure sensors, reflecting the hemodynamic function of the right heart, would be very useful to the clinician responsible for early detection of a deficit in right ventricular function.

Conditions

Complex Congenital Heart Disease; Chronic Right Heart Failure

Keywords

Non-invasive venous pressure measurement

Outcome Measures

Primary Outcomes (1)

• Estimate the concordance between the mean peak atrial pressure values measured by the two methods (invasive and magnetic sensor) over a 15-minute period.

  Average value of the atrial peak pressure measured by both methods (invasive and magnetic sensor) over a 15-minute period.

  Baseline

Secondary Outcomes (5)

• Assess whether there is an overlap between the jugular venous pressure curve obtained with a magnetic sensor and the invasive central venous pressure curve

  baseline

• Assess whether there is an overlap between the jugular venous pressure curve obtained with a magnetic sensor and the invasive central venous pressure curve (atrial filling)

  baseline

• Assess whether there is an overlap between the jugular venous pressure curve obtained with a magnetic sensor and the invasive central venous pressure curve (Area under the pressure curve during a cardiac revolution)

  baseline

• Evaluate whether there is an overlap, during a simultaneous measurement, between the jugular venous pressure curve and the radial arterial pressure curve obtained with a magnetic and the radial arterial pressure curve obtained with a magnetic sensor

  baseline

• To evaluate the safety of measuring jugular venous pressure or radial arterial pressure with a magnetic sensor in patients.

  Baseline

Study Arms (1)

Patient with an indication for right heart catheterization

OTHER

During the preparation of the subject on the cardiac catheterization table, a person specifically trained to the measurements of the medical device under test will be dedicated to this study. Once the skin has been cleaned with alcohol the device (magnet and micro-sensor encapsulated in the plastic support) will be placed on the subject's uninjured skin of the subject, on the path of the jugular vein. A second device will be placed at the level of the radial artery radial artery with the help of a bracelet. The signals will be recorded and observed on a screen for the duration of the invasive hemodynamic measurements, i.e. approximately 15 minutes.

Device: Magnetic sensor

Interventions

Magnetic sensor DEVICE

During the right heart catheterization procedure, measurement of hemodynamic pressures by the non-invasive experimental method (Magnetic sensor) and the invasive control method

Patient with an indication for right heart catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who receives a right-sided catheterization
• Age ≥ 18 years
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Université Montpellier: collaborator

Study Sites (1)

CHU de Montpellier Département de Cardiologie Hôpital Arnaud de Villeneuve

Montpellier, 34090, France

RECRUITING

Study Officials

• Quentin DELBAERE, MD

  CHU de Montpellier

  STUDY DIRECTOR

Central Study Contacts

Quentin DELBAERE, MD

CONTACT

0467332501; q-delbaere@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: comparison between two measurement methods, one of which serves as a reference in a single group of patients patients, without randomization, prospective and monocentric. This is a proof-of-concept pilot study. concept.

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 13, 2023
• Study Start: September 13, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: September 18, 2023

Record last verified: 2023-07

Locations

FR (1)