Right-side heart function after pacemaker, ICD, or CRT implantation

Monitoring Right Ventricular Function in Patients Undergoing Implantable Cardiac Electronic Device (CIED) Therapy: A Multimodal Imaging and Biomarker-Based Approach

This project will see if right heart function changes in adults getting a pacemaker, ICD, or CRT by comparing imaging and a blood test before the device and six months later.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Istanbul University - Cerrahpasa (Academic / other)
• Locations: 1 site (Istanbul, FATIH)
• Trial ID: NCT07272395 on ClinicalTrials.gov

What this trial studies

This is a prospective observational cohort of adults scheduled for clinically indicated pacemaker, ICD, or CRT implantation, with evaluations immediately before implantation and at six months. At each visit participants undergo transthoracic echocardiography with quantitative RV measures, a standardized VEXUS ultrasound score for systemic venous congestion, non-contrast cardiac MRI for RV volumetry and tissue characterization, and a blood draw for the biomarker FGF-23. No experimental devices or therapies are used; imaging and blood sampling are performed for research only and carry minimal additional risk. The study aims to quantify short-term changes in RV size and function after device implantation and to explore whether imaging changes correlate with venous congestion or biomarker shifts.

Who should consider this trial

Good fit: Adults (18+) scheduled for routine implantation of a clinically indicated pacemaker, ICD, or CRT who can undergo echocardiography and non-contrast cardiac MRI and can provide informed consent are ideal candidates.

Not a fit: Patients with MRI contraindications, advanced kidney disease (eGFR <30 or dialysis), known Group 1 pulmonary arterial hypertension, significant congenital heart disease, prosthetic heart valves, or active metabolic bone disorders are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could help clinicians identify patients at higher risk of right ventricular deterioration after device implantation and guide follow-up or preventive strategies.

How similar studies have performed: Prior observational studies have reported device-associated right heart and tricuspid valve changes, but prospective studies that combine CMR, standardized venous ultrasound scoring, and biomarkers such as FGF-23 are limited, so this protocol provides relatively novel integrated data.

Eligibility criteria

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.

Where this trial is running

Istanbul, FATIH

• Istanbul University-Cerrahpasa Institute of Cardiology — Istanbul, Fatih, Turkey (Türkiye) (Recruiting)

Study contacts

• Principal investigator: Sahra Asena Balcioglu — Istanbul University-Cerrahpasa Institute of Cardiology
• Study coordinator: Sahra Asena Balcioglu, Md

Conditions Right Ventricular Dysfunction; right ventricular dysfunction; right ventricular function; Cardiac Implantable Electronic Device; Implantable Cardioverter-Defibrillator; pacemaker; Cardiac Resynchronisation Therapy; Cardiac Magnetic Resonance Imaging