Clinical Trial

Radiation-free Anatomical Direct Imaging Approach for No-fluoroscopy Cardiac Electrode Implantation

Study acronym: RADIANCE
Completed
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Summary
Permanent pacemaker implantation is traditionally performed under fluoroscopic (X-ray) guidance. Although effective, fluoroscopy exposes patients and medical staff to ionizing radiation. Transthoracic echocardiography (TTE) is a non-invasive ultrasound imaging technique that allows real-time visualization of cardiac structures without radiation exposure. However, its role in guiding permanent pacemaker implantation has not been systematically evaluated. This study aims to assess the feasibility and safety of performing permanent pacemaker implantation under sole TTE guidance. In the first phase, eligible patients will undergo pacemaker implantation guided only by transthoracic echocardiography. In the second phase, outcomes of patients treated with TTE guidance will be compared with matched patients undergoing conventional fluoroscopy-guided implantation. The study will evaluate procedural success, lead positioning accuracy, electrical performance, complication rates, and elimination of radiation exposure. The overall goal is to determine whether a radiation-free imaging strategy can safely replace conventional fluoroscopic guidance in selected patients requiring pacemaker implantation.
Trial Details
NCT Number NCT07458724
Lead Sponsor Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions Arrhythmia
Enrollment 31 participants
Start Date 2024-09-01
Primary Completion 2025-09-01 (estimated)
Study Completion 2026-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-09