Cardiac PacingNCT05557006
Change of QRS Morphology and Electrophysiological Characteristics During Pacing Within the Interventricular Septum
An observational study of Cardiac Pacing, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Conduction system pacing (CSP), including His bundle pacing (HBP) and left bundle branch (LBB) pacing (LBBP), as a physiological pacing strategy, can achieve interventricular and/or intra-left ventricular mechanical synchronization by delivering physiological or nearly physiological ventricular activation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacing
- What is being tested?
- left bundle branch pacing
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2022to May 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring a high percentage of ventricular pacing (>40% expected ventricular pacing) include patients with advanced or third-degree atrioventricular block and atrial fibrillation with bradycardia.
Who may be able to join
- The indications for pacemaker implantation are in accordance with the 2021 European Society of Cardiology (ESC) guidelines.
- Patients requiring a high percentage of ventricular pacing (>40% expected ventricular pacing) include patients with advanced or third-degree atrioventricular block and atrial fibrillation with bradycardia.
- Left bundle branch pacing will be performed.
- Patients voluntarily participate and sign informed consent.
Who cannot join
- Atrioventricular block caused by reversible factors such as acute myocardial infarction and electrolyte disturbance.
- Patients with severe liver or renal failure.
- Life expectancy < 1 year.
- Patients with age < 18 years.
- Left ventricular ejection fraction (LVEF) < 40%.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
Yanchun Liang, MD、PhD, +86-13309886380, liangyanchun@sina.com
About this study
Official title: Change of QRS Morphology and Electrophysiological Characteristics During Pacing Within the Interventricular Septum: a Prospective, Observational Study
Conduction system pacing (CSP), including His bundle pacing (HBP) and left bundle branch (LBB) pacing (LBBP), as a physiological pacing strategy, can achieve interventricular and/or intra-left ventricular mechanical synchronization by delivering physiological or nearly physiological ventricular activation. And many studies have verifed clinical efficacy of CSP that it can significantly relieve dyssynchrony of ventricular contraction, improve cardiac function and reduce the risk of heart failure as compared to right ventricular pacing. However, CSP has some shortcomings which limit its widespread application to some extent. As for HBP, although it can achieve optimal physiological ventricular synchronization, the problems of relatively high pacing threshold, low R-wave amplitude, the long-term performance, and inability to correct infra-Hisian atrioventricular block and intraventricular block in some patients have always been concerns. Nevertheless, LBBP is likely free of the restrictions mentioned above. On the contrary, LBBP can capture the left conduction system by directly stimulating the proximal LBB distal to the site of conduction block, thereby achieving rapid and physiological LV activation with a lower and stable pacing threshold and higher R-wave amplitude. However, as a newly emerged physiologic pacing technology, LBBP is currently in the exploratory stage and there are some phenomena to be interpreted, such as the evolution of pacing QRS morphology during the lead penetration into the interventricular septum. Therefore, the aim of this study is to assess the morphological evolution and electrophysiological characteristics of various pacing QRS patterns observed as the lead penetrates the interventricular septum from right to left.
- Conditions
- Cardiac Pacing
- Being tested
- left bundle branch pacing
- Keywords
- Left Bundle Branch Pacing, Left Bundle Branch Area Pacing, Septal Pacing, Left Ventricular Activation Time, Right Ventricular Activation Time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left bundle branch pacingProcedure or surgery
In the procedure of left bundle branch pacing, various QRS morphologies are observed as penetrating the lead into the interventricular septum.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Patients who meet the inclusion criteria Receives: Procedure: left bundle branch pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular activation time (LVAT)
Left ventricular activation time (LVAT) is defined as the interval from the onset of the pacing stimulus to the peak of the R wave in lead V5/6, which reflects the lateral precordial myocardium depolarization time.
Measured: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
Right ventricular activation time (RVAT)
Right ventricular activation time (RVAT) is defined as the interval from the onset of the pacing stimulus to the peak potential recorded by the atrial electrode temporarily placed in the right ventricle, which reflects delayed right ventricular activation.
Measured: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
Paced QRS morphology
Paced QRS morphology during lead penetration through the interventricular septum mainly includes left bundle branch block, intraventricular block and right bundle branch block.
Measured: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
Secondary outcomes (3)
Stimulus-QRSend duration (s-QRSend)
Stimulus-QRSend duration (s-QRSend) is the time from the onset of the pacing stimulus to the end of QRS complex.
Measured: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
The late-R wave duration and amplitude in lead V1 (r´dur、r´amp)
The late-R wave duration in lead V1 indicates delayed right ventricular excitation.
Measured: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
The S wave duration and amplitude in lead V6 (Sdur、Samp)
The S wave duration in lead V6 indicates delayed right ventricular excitation.
Measured: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start27 Sep 2022
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchun Liang, General Hospital of Shenyang Military Region
- Investigators
- Yanchun Liang, MD、PhD, Principal investigator, The General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557006
- Sponsor's protocol ID
- GHNTC-PACE
- Status last verified
- Mar 2023
- First submitted
- 19 Sep 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shimeno K, Tamura S, Nakatsuji K, Hayashi Y, Abe Y, Naruko T. Characteristics and proposed mechanisms of QRS morphology observed during the left bundle branch pacing procedure. Pacing Clin Electrophysiol. 2021 Dec;44(12):1987-1994. doi: 10.1111/pace.14382. Epub 2021 Oct 31.
PubMed 34662435Zhang J, Sheng X, Pan Y, Wang M, Fu G. Electrophysiological Insights into Three Modalities of Left Bundle Branch Area Pacing in Patients Indicated for Pacing Therapy. Int Heart J. 2021 Jan 30;62(1):78-86. doi: 10.1536/ihj.20-490. Epub 2020 Dec 26.
PubMed 33390564
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of QRS Morphology and Electrophysiological Characteristics During Pacing Within the Interventricular Septum: a Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05557006
- Acronym / sponsor ID
- GHNTC-PACE
- Conditions
- Cardiac Pacing
- Keywords
- Left Bundle Branch Pacing, Left Bundle Branch Area Pacing, Septal Pacing, Left Ventricular Activation Time, Right Ventricular Activation Time
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 27 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.
Conduction system pacing (CSP), including His bundle pacing (HBP) and left bundle branch (LBB) pacing (LBBP), as a physiological pacing strategy, can achieve interventricular and/or intra-left ventricular mechanical synchronization by delivering physiological or nearly physiological ventricular activation. And many studies have verifed clinical efficacy of CSP that it can significantly relieve dyssynchrony of ventricular contraction, improve cardiac function and reduce the risk of heart failure as compared to right ventricular pacing. However, CSP has some shortcomings which limit its widespread application to some extent. As for HBP, although it can achieve optimal physiological ventricular synchronization, the problems of relatively high pacing threshold, low R-wave amplitude, the long-term performance, and inability to correct infra-Hisian atrioventricular block and intraventricular block in some patients have always been concerns. Nevertheless, LBBP is likely free of the restrictions mentioned above. On the contrary, LBBP can capture the left conduction system by directly stimulating the proximal LBB distal to the site of conduction block, thereby achieving rapid and physiological LV activation with a lower and stable pacing threshold and higher R-wave amplitude. However, as a newly emerged physiologic pacing technology, LBBP is currently in the exploratory stage and there are some phenomena to be interpreted, such as the evolution of pacing QRS morphology during the lead penetration into the interventricular septum. Therefore, the aim of this study is to assess the morphological evolution and electrophysiological characteristics of various pacing QRS patterns observed as the lead penetrates the interventricular septum from right to left.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Procedure: left bundle branch pacingPatients who meet the inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring a high percentage of ventricular pacing (>40% expected ventricular pacing) include patients with advanced or third-degree atrioventricular block and atrial fibrillation with bradycardia.
Key inclusion criteria (4 listed)
- The indications for pacemaker implantation are in accordance with the 2021 European Society of Cardiology (ESC) guidelines.
- Patients requiring a high percentage of ventricular pacing (>40% expected ventricular pacing) include patients with advanced or third-degree atrioventricular block and atrial fibrillation with bradycardia.
- Left bundle branch pacing will be performed.
- Patients voluntarily participate and sign informed consent.
Key exclusion criteria (5 listed)
- Atrioventricular block caused by reversible factors such as acute myocardial infarction and electrolyte disturbance.
- Patients with severe liver or renal failure.
- Life expectancy < 1 year.
- Patients with age < 18 years.
- Left ventricular ejection fraction (LVEF) < 40%.
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 pacingIn the procedure of left bundle branch pacing, various QRS morphologies are observed as penetrating the lead into the interventricular septum. | Procedure or surgery | All patients |
Primary outcome
Left ventricular activation time (LVAT)
Time frame: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
Left ventricular activation time (LVAT) is defined as the interval from the onset of the pacing stimulus to the peak of the R wave in lead V5/6, which reflects the lateral precordial myocardium depolarization time.
Right ventricular activation time (RVAT)
Time frame: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
Right ventricular activation time (RVAT) is defined as the interval from the onset of the pacing stimulus to the peak potential recorded by the atrial electrode temporarily placed in the right ventricle, which reflects delayed right ventricular activation.
Paced QRS morphology
Time frame: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
Paced QRS morphology during lead penetration through the interventricular septum mainly includes left bundle branch block, intraventricular block and right bundle branch block.
3 secondary outcomes
Stimulus-QRSend duration (s-QRSend)
Time frame: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
The late-R wave duration and amplitude in lead V1 (r´dur、r´amp)
Time frame: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
The S wave duration and amplitude in lead V6 (Sdur、Samp)
Time frame: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 34662435Shimeno K, Tamura S, Nakatsuji K, Hayashi Y, Abe Y, Naruko T. Characteristics and proposed mechanisms of QRS morphology observed during the left bundle branch pacing procedure. Pacing Clin Electrophysiol. 2021 Dec;44(12):1987-1994. doi: 10.1111/pace.14382. Epub 2021 Oct 31.
- Background: PubMed 33390564Zhang J, Sheng X, Pan Y, Wang M, Fu G. Electrophysiological Insights into Three Modalities of Left Bundle Branch Area Pacing in Patients Indicated for Pacing Therapy. Int Heart J. 2021 Jan 30;62(1):78-86. doi: 10.1536/ihj.20-490. Epub 2020 Dec 26.
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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.
Yanchun Liang, MD、PhD principal investigator
The General Hospital of Northern Theater Command
1 site 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, run by General Hospital of Shenyang Military Region 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 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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 Yanchun Liang, MD、PhD (+86-13309886380, liangyanchun@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular activation time (LVAT) (time frame: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.). The study lists 3 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 NCT05557006, 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 16 Mar 2023.