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Right Ventricular Function Changes After CIED Implantation: The RIGHT-CIED Study

NCT07272395 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-12-16

No results posted yet for this study

Summary

This study aims to understand how the right side of the heart changes in people who receive an implantable cardiac electronic device (CIED), such as a pacemaker, ICD, or CRT device. The right ventricle (RV) can sometimes be affected after these devices are placed, but the reasons and timing are not well understood.

To investigate this, we will examine participants at two time-points: before their device is implanted and again six months later. At each visit, we will assess heart function using echocardiography, a non-contrast cardiac MRI scan, and an ultrasound score of venous congestion called the VEXUS score. We will also take a small blood sample to measure a biomarker called FGF-23, which may reflect changes in heart function.

The study does not involve any experimental treatment, and all implanted devices are part of routine medical care. The imaging tests and blood samples are for research purposes only. By comparing the measurements before and after device implantation, we hope to better understand how CIEDs influence right-sided heart function and whether imaging findings are related to changes in blood biomarkers.

Conditions

  • Right Ventricular Dysfunction

Interventions

OTHER

Multimodal Right Ventricular Evaluation

Non-invasive assessments including transthoracic echocardiography, VEXUS ultrasound scoring, non-contrast cardiac MRI using 1.5T scanner, and venous blood sampling for EDTA plasma biomarker analysis (FGF-23 and BNP). These procedures are for research measurements only and do not alter or replace routine clinical care. No therapeutic intervention or assignment is performed.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • SAHRA ASENA BALCIOGLU · ISTANBUL UNIVERSITY-CERRAHPASA INSTITUTE OF CARDIOLOGY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2026-10-21
Completion
2026-11-25

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07272395 on ClinicalTrials.gov