An observational study in Right Ventricular Dysfunction, sponsored by Istanbul University - Cerrahpasa. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Istanbul University - Cerrahpasa · Observational
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.
Right ventricular (RV) dysfunction and tricuspid valve changes are increasingly recognised in patients who receive implantable cardiac electronic devices (CIEDs). Potential mechanisms include lead-leaflet interaction, pacing-related alterations in RV mechanics and changes in venous haemodynamics. However, prospective data integrating advanced imaging, ultrasound-based congestion assessment and circulating biomarkers remain limited.
This prospective observational cohort study will evaluate RV structure and function at two predefined time-points: immediately before CIED implantation and at six months after implantation. Assessments will include (1) transthoracic echocardiography with quantitative RV parameters, (2) a standardised VEXUS ultrasound score for systemic venous congestion, (3) non-contrast cardiac magnetic resonance (CMR) imaging for RV volumetry and tissue characterisation and (4) plasma measurement of FGF-23 as a biomarker potentially associated with RV remodelling.
All implanted devices are clinically indicated and form part of routine care; no experimental device or therapeutic intervention is used. Imaging and blood sampling performed for the study are non-interventional and carry minimal risk. The purpose of the study is to quantify changes in RV size and function over six months and to explore whether alterations in imaging findings correspond to changes in venous congestion or biomarker levels. The results may help identify patients at risk of adverse RV remodelling following CIED implantation.
90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.
Browse Ventricular Dysfunction, Right studies →Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited from the cardiology clinics and electrophysiology unit of Istanbul University-Cerrahpaşa Cardiology Institute. The study population consists of adult patients scheduled for implantation of a clinically indicated pacemaker, ICD, or CRT device. All participants represent a routine tertiary-care population referred for device therapy due to bradyarrhythmia, heart failure, or ventricular arrhythmia indications.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with an indication for the implantation of an implantable cardiac electronic device (pacemaker, ICD, or CRT) as part of routine clinical care. All participants will undergo detailed assessment of right ventricular structure and function immediately before device implantation and again at 6 months after implantation. Assessments include transthoracic echocardiography, VEXUS ultrasound scoring, non-contrast cardiac MRI, and blood sampling for biomarker analysis (FGF-23 and BNP). No experimental intervention is administered; all implanted devices are clinically indicated.
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.
Change in Right Ventricular Ejection Fraction (RVEF) by Cardiac MRI
RVEF will be quantified using non-contrast 1.5T cardiac MRI cine imaging. The primary endpoint is the absolute change in RVEF between pre-implantation and 6-month follow-up.
Time frame: Baseline (pre-implantation) to 6 months post-implantation
Change in Tricuspid Regurgitation Severity
Tricuspid regurgitation will be graded (none, mild, moderate, severe) using echocardiography and confirmed by CMR-derived regurgitant volume.
Time frame: Baseline to 6 months
Change in Right Ventricular End-Diastolic Volume (RVEDV) by Cardiac MRI
RVEDV will be measured from short-axis cine stacks. The endpoint is the change in volume between baseline and 6 months.
Time frame: Baseline to 6 months
Change in VEXUS Score
VEXUS venous congestion score (IVC, hepatic vein Doppler, portal vein pulsatility, renal vein Doppler) will be calculated at each visit.
Time frame: Baseline to 6 months
Change in Right Ventricular Longitudinal Strain (RV-FWLS)
Measured via speckle-tracking echocardiography.
Time frame: Baseline to 6 months
Change in Plasma FGF-23 Concentration
EDTA plasma FGF-23 will be measured via ELISA. The endpoint is the change in concentration from baseline to 6 months.
Time frame: Baseline to 6 months
Change in BNP Concentration
Plasma BNP levels will be measured as a secondary biochemical marker.
Time frame: Baseline to 6 months
Lead-related Tricuspid Valve Interaction
Based on CMR evaluation of lead-leaflet relationship (septal, posteroseptal, anterior leaflet proximity or impingement).
Time frame: 6 months
Plan to share: Yes — De-identified individual participant data (IPD) related to right ventricular measurements, echocardiographic parameters, VEXUS scores, cardiac MRI-derived volumetric results, and biomarker values (FGF-23 and BNP) may be shared. No direct identifiers, imaging files, or raw MRI data will be provided. Only anonymised numerical data used for statistical analysis will be available.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: IPD will be available from 12 months to 5 years after publication.
Access criteria: De-identified individual participant data (IPD) will be accessible to qualified researchers affiliated with recognised academic or clinical institutions. Access will be granted for the purpose of scientific analysis only, upon submission of a reasonable research proposal and approval by the study investigators. Data will be shared in an anonymised electronic format via secure data transfer. No identifiable information, imaging files, or raw MRI datasets will be provided.
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