Radiation-free Anatomical Direct Imaging Approach for No-fluoroscopy Cardiac Electrode Implantation (NCT07458724) | Clinical Trial Compass
CompletedNot Applicable
Radiation-free Anatomical Direct Imaging Approach for No-fluoroscopy Cardiac Electrode Implantation
China31 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years
✓. Indication for permanent pacemaker implantation according to current ESC or ACC/AHA guidelines
✓. Adequate transthoracic echocardiographic acoustic window allowing visualization of right atrium, right ventricle, and interventricular septum