Left Bundle Branch PacingNCT05553431
Feasibility of Simplified Permanent Left Bundle Branch Pacing Without Electrophysiological Recording System
A study testing Left bundle branch pacing in people with Left Bundle Branch Pacing, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This is a prospective, single-center study of patients with an indication for ventricular pacing who attempted LBBP without electrophysiology recording system (EP system). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Bundle Branch Pacing
- What is being tested?
- Left bundle branch pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2022to Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) requiring ventricular pacing; (2) older than 18 years; (3) signed informed consent.
Who cannot join
- (1) acute anterior myocardial infarction; (2) intraventricular conduction delay (IVCD); (3) ventricular septal hypertrophy (end-diastolic thickness over 15 mm).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affliated Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Weijian Huang, MD, +86 138-0669-1086, weijianhuang69@126.com
Lan Su, +86 137-3874-2616, 2512057600@qq.com
About this study
Official title: Feasibility of Simplified Permanent Left Bundle Branch Pacing (LBBP) Without Electrophysiological Recording System
This is a prospective, single-center study of patients with an indication for ventricular pacing who attempted LBBP without electrophysiology recording system (EP system).
Read the detailed description
Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, the implanter was blinded to EP system, only refer to ECG monitoring. The transition of QRS morphology from S-LBBP (or LVSP) to NS-LBBP, abrupt shortening of Stim-LVAT in lead V5, combined with LV septal-derived PVCs and obvious LBB potential in pacing system analyzer were recorded to help the implanter confirm LBB capture. Meanwhile, the technician recorded the data by EP system and evaluated the consistency of the judgment. The primary endpoints included the success rate, procedure-related information, parameters and complications during 3-month follow-up.
- Conditions
- Left Bundle Branch Pacing
- Being tested
- Left bundle branch pacing
- Keywords
- Left Bundle Branch Pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left bundle branch pacingDevice
Left bundle branch pacing by a CRT device or dual-chamber pacemaker through the pacing lead at left bundle branch region
| Study group | Role | What they receive |
|---|---|---|
| No EP system Group | Experimental | Patients were performed left bundle branch pacing without EP system. Receives: Device: Left bundle branch pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful rate
Success rate of left bundle branch pacing without EP system
Measured: Immediate Postoperative
Judgment coincidence rate
Coincidence rate between the judgment made by the operator through ECG and PSA with EP system.
Measured: Intraoperative
Intraoperative complications
Intraoperative complications were recorded
Measured: Immediate Postoperative
Postoperative complications
Postoperative complications were recorded
Measured: 3 months
Secondary outcomes (5)
Procedure duration
Total time required for operation
Measured: Immediate Postoperative
Fluoroscopy time
Intraoperative time of radiation use
Measured: Immediate Postoperative
Change of threshold(V/0.5ms) from immediate postoperative
Threshold for capturing left bundle branch during unipolar pacing
Measured: 3 months
Change of LVEF(%) from baseline
LVEF changes before and after surgery
Measured: 3 months
Change of impedance(Ω) from immediate postoperative
Impedance during unipolar pacing
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Left Bundle Branch PacingStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weijian Huang, MD, Principal investigator, Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553431
- Sponsor's protocol ID
- FirstWenzhouMU078
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Su L, Wang S, Wu S, Xu L, Huang Z, Chen X, Zheng R, Jiang L, Ellenbogen KA, Whinnett ZI, Huang W. Long-Term Safety and Feasibility of Left Bundle Branch Pacing in a Large Single-Center Study. Circ Arrhythm Electrophysiol. 2021 Feb;14(2):e009261. doi: 10.1161/CIRCEP.120.009261. Epub 2021 Jan 9.
PubMed 33426907Vijayaraman P, Subzposh FA, Naperkowski A, Panikkath R, John K, Mascarenhas V, Bauch TD, Huang W. Prospective evaluation of feasibility and electrophysiologic and echocardiographic characteristics of left bundle branch area pacing. Heart Rhythm. 2019 Dec;16(12):1774-1782. doi: 10.1016/j.hrthm.2019.05.011. Epub 2019 May 25.
PubMed 31136869Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22.
PubMed 29173611
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Simplified Permanent Left Bundle Branch Pacing (LBBP) Without Electrophysiological Recording System
- ClinicalTrials.gov ID
- NCT05553431
- Acronym / sponsor ID
- FirstWenzhouMU078
- Conditions
- Left Bundle Branch Pacing
- Keywords
- Left Bundle Branch Pacing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Sep 2022 (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.
This is a prospective, single-center study of patients with an indication for ventricular pacing who attempted LBBP without electrophysiology recording system (EP system).
Detailed description
Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, the implanter was blinded to EP system, only refer to ECG monitoring. The transition of QRS morphology from S-LBBP (or LVSP) to NS-LBBP, abrupt shortening of Stim-LVAT in lead V5, combined with LV septal-derived PVCs and obvious LBB potential in pacing system analyzer were recorded to help the implanter confirm LBB capture. Meanwhile, the technician recorded the data by EP system and evaluated the consistency of the judgment. The primary endpoints included the success rate, procedure-related information, parameters and complications during 3-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No EP system Group | Experimental | Device: Left bundle branch pacingPatients were performed left bundle branch pacing without EP system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) requiring ventricular pacing; (2) older than 18 years; (3) signed informed consent.
Key exclusion criteria (1 listed)
- (1) acute anterior myocardial infarction; (2) intraventricular conduction delay (IVCD); (3) ventricular septal hypertrophy (end-diastolic thickness over 15 mm).
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 |
|---|---|---|
| Left bundle branch pacingLeft bundle branch pacing by a CRT device or dual-chamber pacemaker through the pacing lead at left bundle branch region | Device | No EP system Group |
Primary outcome
Successful rate
Time frame: Immediate Postoperative
Success rate of left bundle branch pacing without EP system
Judgment coincidence rate
Time frame: Intraoperative
Coincidence rate between the judgment made by the operator through ECG and PSA with EP system.
Intraoperative complications
Time frame: Immediate Postoperative
Intraoperative complications were recorded
Postoperative complications
Time frame: 3 months
Postoperative complications were recorded
5 secondary outcomes
Procedure duration
Time frame: Immediate Postoperative
Fluoroscopy time
Time frame: Immediate Postoperative
Change of threshold(V/0.5ms) from immediate postoperative
Time frame: 3 months
Change of LVEF(%) from baseline
Time frame: 3 months
Change of impedance(Ω) from immediate postoperative
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Background: PubMed 33426907Su L, Wang S, Wu S, Xu L, Huang Z, Chen X, Zheng R, Jiang L, Ellenbogen KA, Whinnett ZI, Huang W. Long-Term Safety and Feasibility of Left Bundle Branch Pacing in a Large Single-Center Study. Circ Arrhythm Electrophysiol. 2021 Feb;14(2):e009261. doi: 10.1161/CIRCEP.120.009261. Epub 2021 Jan 9.
- Background: PubMed 31136869Vijayaraman P, Subzposh FA, Naperkowski A, Panikkath R, John K, Mascarenhas V, Bauch TD, Huang W. Prospective evaluation of feasibility and electrophysiologic and echocardiographic characteristics of left bundle branch area pacing. Heart Rhythm. 2019 Dec;16(12):1774-1782. doi: 10.1016/j.hrthm.2019.05.011. Epub 2019 May 25.
- Background: PubMed 29173611Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Weijian Huang, MD principal investigator
Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left bundle branch pacing in people with Left Bundle Branch Pacing, run by First Affiliated Hospital of Wenzhou Medical University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weijian Huang, MD (+86 138-0669-1086, weijianhuang69@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful rate (time frame: Immediate Postoperative). The study lists 4 primary outcomes in all. 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 NCT05553431, which also lists 3 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 23 Sep 2022.