MedTrace Logo

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

NCT07458724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-03-09

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Permanent Pacemaker Implantation

Permanent pacemaker implantation performed under sole transthoracic echocardiographic (TTE) guidance without the use of fluoroscopy. Venous access, lead advancement, positioning, and fixation are guided by real-time transthoracic imaging. Ventricular leads are positioned at the interventricular septum under direct echocardiographic visualization. In dual-chamber systems, atrial leads are positioned at the atrial septum due to limitations in visualizing the right atrial appendage under transthoracic imaging. Lead position, septal contact, and potential procedural complications (e.g., pericardial effusion, valvular interference) are continuously assessed using multi-plane echocardiographic views. Fluoroscopy is reserved only for bailout situations if adequate lead positioning cannot be achieved under TTE guidance.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    lead OTHER

Principal Investigators

  • Xiangbin Pan, MD, PhD · National Center for Cardiovascular Disease, China & Fuwai Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-09-01
Completion
2026-02-01
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07458724 on ClinicalTrials.gov