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

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.

Inclusion criteria

• Adults aged 18 years or older.
• Scheduled to undergo implantation of a clinically indicated pacemaker, ICD, or CRT device.
• Able to undergo transthoracic echocardiography, VEXUS ultrasound assessment, and non-contrast cardiac MRI.
• Able to provide written informed consent.

Exclusion criteria

• Contraindication to cardiac MRI (e.g., severe claustrophobia or MRI-unsafe implanted material).
• Inability to undergo echocardiography or ultrasound assessment.
• Known pulmonary arterial hypertension (Group 1 PH).
• Significant congenital heart disease.
• Patients with mechanical or bioprosthetic heart valve replacement
• Severe left-sided valvular disease (severe AS or severe MR).
• Chronic kidney disease stage 4 or 5 (eGFR < 30 mL/min/1.73m²).
• End-stage renal disease requiring dialysis.
• Primary hyperparathyroidism.
• Hypophosphataemia or hyperphosphataemia requiring treatment.
• Active or uncontrolled bone metabolism disorders (e.g., osteomalacia, Paget's disease).
• Recent fracture or major orthopaedic surgery within the past 3 months.
• Active systemic inflammatory or autoimmune disease.
• Active malignancy or malignancy requiring ongoing treatment.
• Active infection at the time of enrolment.
• Pregnancy or breastfeeding.
• Haemodynamic instability at the time of enrolment.
• Expected survival less than 6 months due to non-cardiac conditions.
• Inability to provide informed consent.