Cardiac PacingNCT04119323

Image Location and Performance of Left Bundle Branch Pacing

An observational study of Cardiac Pacing and Pacing Therapy, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, multi-site, non-randomized, data collection study. The purpose of this study is to investigate the correlation between pacing sites and ECG morphology or pacing parameters during left bundle branch pacing (LBBP) and perform the use condition analysis to assess the long-term performance of pacing… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Cardiac Pacing, Pacing Therapy
How many people: 50 participants
Where: 3 sitesChina
Study dates: 24 Sep 2019to 14 Jul 2020
Phase: Observational
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

Study population: Patients indicated for LBBP and implanted with pacing lead for LBBP.

Who may be able to join

Aged from 18 to 80 years old;
Patients providing signed Informed Consent;
Patients indicated for permanent pacing and implanted with LBBP for at least 3 months, with documentation of implantation records;
Patients who plan to receive cardiac CT examination.

Who cannot join

Patients who have a history of allergy to contrast agent or refuse to use contrast agent in CT examination;
Patients who are pregnant or have a plan for pregnancy during the study;
Patients who are not willing to provide Informed Consent;
Patients who have medical conditions that would limit study participation;
Patients who were already enrolled in other clinical trial which would impact his/her participation.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Fuwai Hospital
Beijing, Beijing Municipality, 010
West China Hospital
Chengdu, Sichuan, 028
Jiangsu Province Hospital
Nanjing, Jiangsu, 025

Other trials in China

About this study

Read the detailed description

His bundle pacing (HBP) is a physiological pacing, but also has some limitations, including high and unstable pacing threshold in 5-10% patients, low R-wave amplitude causing inappropriate pacing management, damage to the His bundle during implantation. On the other hand, left bundle branch pacing (LBBP), achieved via trans-ventricular septal approach with the pacing lead tip at the left side of the ventricular septum, has recently initiated and been widely practiced in China because of easy implantation, relatively narrow paced QRS duration, low and stable pacing threshold, high R wave amplitude, and the LBBB correction by a low pacing output.

As LBBP is in the early phase of clinical practice in China, in order to better conduct LBBP implantation and understand mechanisms of LBBP therapy, physicians often do imaging assessment of the pacing lead in patients implanted with LBBP based on clinical necessity.

Additionally, there is no report of mid/long-term correlation between lead location and ventricular electrical activity, nor mid/long-term pacing lead performance assessment during LBBP.

Conditions: Cardiac Pacing, Pacing Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

QRS duration
The primary endpoint is QRS duration and morphology during LBBP
Measured: at least 3 months after implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201914 Jul 2020

First posted8 Oct 2019
Study start24 Sep 2019
Primary completion14 Jul 2020
Study completion14 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cardiac PacingStudies of the same condition, open and under way.
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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04119323
Sponsor's protocol ID: IMAGE-LBBP study
Status last verified: Dec 2020
First submitted: 30 Sep 2019
Last updated: 11 Dec 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Cai M, Qiu Y, Xu Y, Lu H, Chen Z, Hou X, Jiang L, Zhou X, Dai Y, Liu X, Zou J, Chen K. Distance From Pacing Lead Tip to Left Ventricular Cavity Predicts Long-term Loss of Left Bundle Branch Capture: Insights From the IMAGE-LBBP Cohort. Can J Cardiol. 2026 Apr;42(4):739-749. doi: 10.1016/j.cjca.2025.10.032. Epub 2025 Nov 1.
PubMed 41177376
Zou J, Chen K, Liu X, Xu Y, Jiang L, Dai Y, Lin J, Hou X, Qiu Y, Himes A, Lucas R, Demmer W, Mara N, Zhou X, Lu H. Clinical use conditions of lead deployment and simulated lead fracture rate in left bundle branch area pacing. J Cardiovasc Electrophysiol. 2023 Mar;34(3):718-725. doi: 10.1111/jce.15843. Epub 2023 Feb 14.
PubMed 36738153

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiac Pacing trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Image Location and Performance of Left Bundle Branch Pacing
ClinicalTrials.gov ID: NCT04119323
Acronym / sponsor ID: IMAGE-LBBP study
Conditions: Cardiac Pacing, Pacing Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: 24 Sep 2019 (actual)
Primary completion: 14 Jul 2020 (actual)
Study completion: 14 Jul 2020 (actual)
First posted: 8 Oct 2019 (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.

Detailed description

Additionally, there is no report of mid/long-term correlation between lead location and ventricular electrical activity, nor mid/long-term pacing lead performance assessment during LBBP.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients indicated for LBBP and implanted with pacing lead for LBBP.

Key inclusion criteria (4 listed)

Aged from 18 to 80 years old;
Patients providing signed Informed Consent;
Patients indicated for permanent pacing and implanted with LBBP for at least 3 months, with documentation of implantation records;
Patients who plan to receive cardiac CT examination.

Key exclusion criteria (5 listed)

Patients who have a history of allergy to contrast agent or refuse to use contrast agent in CT examination;
Patients who are pregnant or have a plan for pregnancy during the study;
Patients who are not willing to provide Informed Consent;
Patients who have medical conditions that would limit study participation;
Patients who were already enrolled in other clinical trial which would impact his/her participation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

QRS duration
Time frame: at least 3 months after implant
The primary endpoint is QRS duration and morphology during LBBP

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 11 Dec 2020.
Derived from this study: PubMed 41177376Cai M, Qiu Y, Xu Y, Lu H, Chen Z, Hou X, Jiang L, Zhou X, Dai Y, Liu X, Zou J, Chen K. Distance From Pacing Lead Tip to Left Ventricular Cavity Predicts Long-term Loss of Left Bundle Branch Capture: Insights From the IMAGE-LBBP Cohort. Can J Cardiol. 2026 Apr;42(4):739-749. doi: 10.1016/j.cjca.2025.10.032. Epub 2025 Nov 1.
Derived from this study: PubMed 36738153Zou J, Chen K, Liu X, Xu Y, Jiang L, Dai Y, Lin J, Hou X, Qiu Y, Himes A, Lucas R, Demmer W, Mara N, Zhou X, Lu H. Clinical use conditions of lead deployment and simulated lead fracture rate in left bundle branch area pacing. J Cardiovasc Electrophysiol. 2023 Mar;34(3):718-725. doi: 10.1111/jce.15843. Epub 2023 Feb 14.

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RecruitingObservational study
BIO|STREAM.CSP Study
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Active, not recruiting
BIO|MASTER.CSP Study
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RecruitingObservational study
Patient Selection and Long-Term Outcomes of Pace & Ablate Strategy in Atrial Fibrillation
Atrial Fibrillation (AF), Cardiomyopathy, Secondary
Recruiting
Postoperative Pacing for Cardiac Efficiency
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Not yet recruiting
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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.

Xiaohong Zhou, M.D. study director

Medtronic

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Pacing and Pacing Therapy, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites 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 5 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 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

QRS duration (time frame: at least 3 months after implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04119323, which also lists 2 linked publications.

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 11 Dec 2020; AzTrials last refreshed its copy on 1 Nov 2026.