Comparison Between a Robotic Tele-echo-cardiography Technique and a Standard Echocardiography in the Management of Heart Failure in the Guadeloupe Archipelago Between the University Hospital of Guadeloupe and the Marie-Galante Hospital

NCT07265986 | Recruiting

• 1 other identifier: PAP_RI2_2019/02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

The TERdeblue-S study is a feasibility study of robotic remote echocardiography, not only in terms of technology but also in terms of its integration into a telemedicine system to improve access to the heart failure management system in the Guadeloupe archipelago. The main objective of this study is to study the agreement of the measurement of the left ventricular ejection fraction (FejVG) between in situ echocardiography (EIS) and two-dimensional remote echocardiography (TER) (distance and volumes).

Conditions

Heart Failure; Remote Consultation, Teleconsultation; Echocardiography, Doppler

Keywords

heart failure; remote echocardiography doppler; telemedicine

Outcome Measures

Primary Outcomes (1)

• Agreement of Left Ventricular Ejection Fraction (LVEF) Measurements Between Echocardiography Techniques

  The main outcome measure is the agreement of left ventricular ejection fraction (LVEF) measurements between two echocardiography techniques. Agreement will be quantified using the intraclass correlation coefficient (ICC) and supplemented by Bland-Altman plots to visualize differences between methods.

  Measured at the second visit (V2) at 2 weeks.

Secondary Outcomes (9)

• Agreement Between Echocardiography Techniques for Diagnosis of Cardiac Anomalies

  Measured at the second visit (V2) at 2 weeks.

• Dilated Cardiomyopathy Assessment

  Measured at Visit 2 (V2), 2 weeks after baseline.

• Quantitative Echocardiographic Measures

  Measured at the second visit (V2) at 2 weeks.

• Hypertrophic Cardiomyopathy Assessment

  Measured at Visit 2 (V2), 2 weeks after baseline.

• Valvulopathy Assessment

  Measured at V2 (2 weeks)

Study Arms (2)

Arm A: in situ ultrasound (EIS) performed first

EXPERIMENTAL

The in situ ultrasound (EIS) is performed first. Cardiologist A performs the imaging examination and then leaves the room. The Research Nurse installs the probe and then cardiologist B, positioned on the expert site in Guadeloupe, carries out the examination of robotic tele-echo-cardiography (TER). Cardiologist B communicates via videoconferencing with the patient and the Research Nurse.

Diagnostic Test: in situ echocardiography (EIS); Diagnostic Test: two-dimensional remote echocardiography (TER)

Arm B: two-dimensional remote echocardiography (TER) performed first

EXPERIMENTAL

The TER is carried out first. The probe is installed by the REsearch Nurse, cardiologist B positioned on the expert site of Guadeloupê carries out the TER examination. Cardiologist B communicates via videoconferencing with the patient and the remote assistant EDI. Then, once the examination is completed, cardiologist A performs the HIA.

Diagnostic Test: in situ echocardiography (EIS); Diagnostic Test: two-dimensional remote echocardiography (TER)

Interventions

two-dimensional remote echocardiography (TER) DIAGNOSTIC_TEST

Remote echocardiography is performed by a cardiologist from a private practice in Guadeloupe, with a research nurse present at the patient's side at Marie-Galante Hospital.

Arm A: in situ ultrasound (EIS) performed first; Arm B: two-dimensional remote echocardiography (TER) performed first

in situ echocardiography (EIS) DIAGNOSTIC_TEST

In situ echocardiography (EIS) will be performed by the cardiologist present in Marie-Galante Hospital.

Arm A: in situ ultrasound (EIS) performed first; Arm B: two-dimensional remote echocardiography (TER) performed first

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Free, informed and written consent signed by the participant and the investigator
• Person affiliated or benefiting from a social security scheme.
• Patient meeting at least one of the following criteria:
• Systematic cardiovascular check-up or asymptomatic patient with cardiovascular risk factor (hypertension, diabetes, obesity, tobacco, alcohol)
• Clinical suspicion of heart disease and/or chronic heart failure with stability of at least one week.
• Family history of heart disease and/or sudden death

You may not qualify if:

• Patient requiring urgent cardiological management with transfer to the University Hospital
• Acute unstable heart failure, admission to CH Marie-Galante less than 5 days (less than one week)
• Pregnant women

Sponsors & Collaborators

• GIRCI SOHO: collaborator
• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (3)

Centre Hospitalier Sainte-Marie de Marie-Galante

Grand-Bourg, 97122, Guadeloupe

RECRUITING

Centre de Cardiologie Zac Colin

Petit-Bourg, 97170, Guadeloupe

NOT YET RECRUITING

Cabinet de cardiologie TONCOEURTONKA

Petit-Canal, 97131, Guadeloupe

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mona Hedreville, MD

  STUDY CHAIR

Central Study Contacts

melanie petapermal, Master degree

CONTACT

+590590934667; melanie.petapermal@chu-guadeloupe.fr

Valérie Hamony Soter

CONTACT

+590590934677; valerie.soter@chu-guadeloupe.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective multicentre study (one cardiologist in a private practice in Guadeloupe and one at the Marie-Galante Hospital) interventional cross-over study in which the measurements obtained successively by tele-echo-cardiography and standard echocardiography will be compared. Among the set of parameters to be measured, we have chosen the left ventricular ejection fraction (LVEF) as the main judgement criterion because this measure defines the type of heart failure.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 5, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): September 8, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GU (3)