ArrhythmiaRADIANCENCT07458724
Radiation-free Anatomical Direct Imaging Approach for No-fluoroscopy Cardiac Electrode Implantation
A study testing Permanent Pacemaker Implantation in people with Arrhythmia, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Permanent pacemaker implantation is traditionally performed under fluoroscopic (X-ray) guidance. Although effective, fluoroscopy exposes patients and medical staff to ionizing radiation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Permanent Pacemaker Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, 100037
About this study
Official title: Feasibility and Safety of Transthoracic Echocardiography-Guided Permanent Pacemaker Implantation Without Fluoroscopy
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.
Read the detailed description
Fluoroscopy-guided permanent pacemaker implantation has been the standard imaging strategy for decades. While fluoroscopy provides reliable projection-based visualization of lead advancement, it exposes patients and medical personnel to ionizing radiation and does not allow direct visualization of myocardial tissue contact or early structural complications. Increasing awareness of cumulative radiation exposure has led to the exploration of alternative imaging strategies in structural and electrophysiological interventions.
Transthoracic echocardiography (TTE) provides real-time, radiation-free visualization of cardiac chambers, septal structures, valvular anatomy, and the pericardial space. TTE has been successfully applied in selected structural heart procedures; however, its use in guiding permanent pacemaker implantation has not been systematically studied. The principal challenges of TTE-guided pacing include limited visualization of the entire lead shaft, difficulty in assessing three-dimensional orientation, and uncertainty regarding fixation mechanics. With procedural refinements and structured imaging protocols, these limitations may be overcome.
This study is designed to evaluate a radiation-free implantation strategy using sole transthoracic echocardiographic guidance. The first component prospectively assesses procedural feasibility and safety in consecutively enrolled patients. The second component compares outcomes of the TTE-guided cohort with a matched cohort undergoing conventional fluoroscopy-guided implantation. The same prospectively enrolled TTE cohort will serve both feasibility assessment and comparative analysis.
The central hypothesis is that TTE-guided pacemaker implantation can achieve high procedural success and acceptable electrical performance while eliminating radiation exposure and maintaining safety comparable to conventional fluoroscopic guidance. By leveraging direct septal visualization and continuous structural monitoring, this approach may provide mechanistic advantages in lead positioning accuracy and complication detection.
If validated, this strategy could represent an important step toward fully radiation-free electrophysiological and structural cardiac interventions.
- Conditions
- Arrhythmia
- Being tested
- Permanent Pacemaker Implantation
- Keywords
- arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permanent Pacemaker ImplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| TTE-guided arm | Experimental | Transthoracic Echocardiography-Guided Pacemaker Implantation Receives: Procedure: Permanent Pacemaker Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initiation of vascular access to hospital discharge, assessed up to 5 days after the index procedure.
Secondary outcomes (7)
Total Procedure Time
Total procedure time measured from skin preparation to wound dressing completion.
Measured: During the index procedure (single-day assessment at Day 0).
Lead Positioning Time
Time required to achieve stable ventricular septal lead positioning and atrial septal lead positioning under imaging guidance.
Measured: During the index procedure (single-day assessment at Day 0).
Radiation Exposure
Total fluoroscopy time (minutes) and cumulative radiation dose (mGy). For the TTE-guided group, fluoroscopy time is expected to be zero unless bailout conversion is required.
Measured: During the index procedure (single-day assessment at Day 0).
Acute Electrical Performance
Atrial and ventricular pacing thresholds, sensing amplitude, and lead impedance measured at implantation.
Measured: Immediately post-implantation (Day 0, within 24 hours after device placement).
Electrical Stability at 3 Months
Maintenance of acceptable pacing thresholds and absence of lead dislodgement.
Measured: Assessed at 3 months (±14 days) after implantation.
Major Procedural Complications
Composite of cardiac perforation, pericardial tamponade, pneumothorax, major vascular injury, pocket hematoma requiring intervention, device infection, or procedure-related mortality.
Measured: From the date of the index procedure until the first occurrence of a major procedural complication or completion of 12-month follow-up, whichever occurs first.
Structural Cardiac Impact
New pericardial effusion or significant progression of tricuspid regurgitation assessed by transthoracic echocardiography.
Measured: Assessed at discharge (≤5 days), 3 months (±14 days), 6 months (±30 days), and 12 months (±30 days) after implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Sep 2024
- Primary completion1 Sep 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiangbin Pan, MD, PhD, Study chair, National Center for Cardiovascular Disease, China & Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458724
- Sponsor's protocol ID
- 2025-2617
- Other IDs
- BRWEP2024W014030105
- Acronym
- RADIANCE
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional data protection policies and the relatively small sample size, which may increase the risk of participant re-identification. De-identified aggregate data will be reported in peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Transthoracic Echocardiography-Guided Permanent Pacemaker Implantation Without Fluoroscopy
- ClinicalTrials.gov ID
- NCT07458724
- Acronym / sponsor ID
- RADIANCE / 2025-2617
- Conditions
- Arrhythmia
- Keywords
- arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fluoroscopy-guided permanent pacemaker implantation has been the standard imaging strategy for decades. While fluoroscopy provides reliable projection-based visualization of lead advancement, it exposes patients and medical personnel to ionizing radiation and does not allow direct visualization of myocardial tissue contact or early structural complications. Increasing awareness of cumulative radiation exposure has led to the exploration of alternative imaging strategies in structural and electrophysiological interventions.
Transthoracic echocardiography (TTE) provides real-time, radiation-free visualization of cardiac chambers, septal structures, valvular anatomy, and the pericardial space. TTE has been successfully applied in selected structural heart procedures; however, its use in guiding permanent pacemaker implantation has not been systematically studied. The principal challenges of TTE-guided pacing include limited visualization of the entire lead shaft, difficulty in assessing three-dimensional orientation, and uncertainty regarding fixation mechanics. With procedural refinements and structured imaging protocols, these limitations may be overcome.
This study is designed to evaluate a radiation-free implantation strategy using sole transthoracic echocardiographic guidance. The first component prospectively assesses procedural feasibility and safety in consecutively enrolled patients. The second component compares outcomes of the TTE-guided cohort with a matched cohort undergoing conventional fluoroscopy-guided implantation. The same prospectively enrolled TTE cohort will serve both feasibility assessment and comparative analysis.
The central hypothesis is that TTE-guided pacemaker implantation can achieve high procedural success and acceptable electrical performance while eliminating radiation exposure and maintaining safety comparable to conventional fluoroscopic guidance. By leveraging direct septal visualization and continuous structural monitoring, this approach may provide mechanistic advantages in lead positioning accuracy and complication detection.
If validated, this strategy could represent an important step toward fully radiation-free electrophysiological and structural cardiac interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTE-guided arm | Experimental | Procedure: Permanent Pacemaker ImplantationTransthoracic Echocardiography-Guided Pacemaker Implantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permanent Pacemaker ImplantationPermanent 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. | Procedure or surgery | TTE-guided arm |
Primary outcome
Procedural Feasibility and Success Rate
Time frame: From initiation of vascular access to hospital discharge, assessed up to 5 days after the index procedure.
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.
7 secondary outcomes
Total Procedure Time
Time frame: During the index procedure (single-day assessment at Day 0).
Lead Positioning Time
Time frame: During the index procedure (single-day assessment at Day 0).
Radiation Exposure
Time frame: During the index procedure (single-day assessment at Day 0).
Acute Electrical Performance
Time frame: Immediately post-implantation (Day 0, within 24 hours after device placement).
Electrical Stability at 3 Months
Time frame: Assessed at 3 months (±14 days) after implantation.
Major Procedural Complications
Time frame: From the date of the index procedure until the first occurrence of a major procedural complication or completion of 12-month follow-up, whichever occurs first.
Structural Cardiac Impact
Time frame: Assessed at discharge (≤5 days), 3 months (±14 days), 6 months (±30 days), and 12 months (±30 days) after implantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional data protection policies and the relatively small sample size, which may increase the risk of participant re-identification. De-identified aggregate data will be reported in peer-reviewed publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangbin Pan, MD, PhD study chair
National Center for Cardiovascular Disease, China & Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permanent Pacemaker Implantation in people with Arrhythmia, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Feasibility and Success Rate (time frame: From initiation of vascular access to hospital discharge, assessed up to 5 days after the index procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.