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

NCT07458724 | Completed FDA Device

• 2 other identifiers: 2025-2617BRWEP2024W014030105
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Arrhythmia

Keywords

arrhythmia

Outcome Measures

Primary Outcomes (1)

• Procedural Feasibility and Success Rate

  Feasibility phase: Successful completion of permanent pacemaker implantation under sole transthoracic echocardiographic (TTE) guidance without fluoroscopic conversion and with acceptable acute electrical parameters (capture threshold ≤1.5 V at 0.4 ms, stable sensing amplitude, and lead impedance within manufacturer-recommended range). Comparative phase: Successful device implantation without major procedural complications and with acceptable acute electrical parameters.

  From initiation of vascular access to hospital discharge, assessed up to 5 days after the index procedure.

Secondary Outcomes (7)

• Total Procedure Time

  During the index procedure (single-day assessment at Day 0).

• Lead Positioning Time

  During the index procedure (single-day assessment at Day 0).

• Radiation Exposure

  During the index procedure (single-day assessment at Day 0).

• Acute Electrical Performance

  Immediately post-implantation (Day 0, within 24 hours after device placement).

• Electrical Stability at 3 Months

  Assessed at 3 months (±14 days) after implantation.

Study Arms (1)

TTE-guided arm

EXPERIMENTAL

Transthoracic Echocardiography-Guided Pacemaker Implantation

Procedure: Permanent Pacemaker Implantation

Interventions

Permanent Pacemaker Implantation PROCEDURE

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.

TTE-guided arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ability to provide written informed consent

You may not qualify if:

• Inadequate transthoracic acoustic window precluding reliable visualization of right-sided cardiac structures
• Severe tricuspid regurgitation (moderate-to-severe or greater)
• Left ventricular ejection fraction \<35% without indication for cardiac resynchronization therapy
• Documented malignant ventricular arrhythmia requiring implantable cardioverter-defibrillator as primary indication
• Intrinsic heart rate \<40 beats per minute with hemodynamic instability requiring emergent pacing
• Active systemic infection
• Pregnancy
• Life expectancy less than 12 months due to non-cardiac comorbidities

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, 100037, China

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiangbin Pan, MD, PhD

  National Center for Cardiovascular Disease, China & Fuwai Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 9, 2026
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)