Slow Arrhythmia; Left Bundle Branch Pacing; Cardiac FunctionNCT04386473
Comparison of Cardiac Function Between Left Bundle Branch Pacing and Right Ventricular Outflow Tract Septal Pacing in Pacemaker-dependent Patients
An observational study of Slow Arrhythmia; Left Bundle Branch Pacing; Cardiac Function, run by Ruiqin xie at 1 site in China.
Trial summary
Permanent pacemaker implantation is a common method for bradycardia and cardiac conduction dysfunction. With the development of physiological pacing, the optimal location of ventricular pacing site is still improving. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Slow Arrhythmia; Left Bundle Branch Pacing; Cardiac Function
- What is being tested?
- pacemaker
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Dec 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pacemaker-dependent patients who agreed to implant a pacemaker.
Who may be able to join
- Pacemaker-dependent patients who agreed to implant a pacemaker.
Who cannot join
- Patients with congenital heart diseases, such as atrial septal defect, ventricular septal defect, or rheumatic heart diseases, valvular heart diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Permanent pacemaker implantation is a common method for bradycardia and cardiac conduction dysfunction. With the development of physiological pacing, the optimal location of ventricular pacing site is still improving. Traditional ventricular pacing site at the apex of right ventricle or septum of right ventricular outflow tract（RVOT）, causing iatrogenic left bundle branch block and asynchronous ventricular contraction, leading to cardiac remodeling, pacemaker-mediated cardiomyopathy and congestive cardiac failure. Long-term chronic ventricular pacing can lead to changes in endocardial myocytes and myofibrils and promote fibrosis. Thus, the alternative pacing site, HIS bundle pacing, has been sought later. The safety and feasibility of permanent HIS bundle pacing have been confirmed in patients with various cardiac diseases. However, the shortcomings of high and unstable threshold, long implantation time, low R-wave amplitude and HIS bundle damage during implantation limit the application of HIS pacing especially in patients with infra-Hisian block. Left bundle branch pacing(LBBP) is a new technique evolved from HIS bundle pacing. In 2017, Huang et al[9]reported that LBBP was successfully paced using 3830 leads(Medronic Inc. USA). The advantages of narrow QRS duration, low threshold, high R wave amplitude, easy fixation and correction of left bundle branch block made LBBP more widely used in clinic.However, whether left bundle branch pacing is superior to traditional right ventricular outflow tract septal pacing in cardial function is still lack of sufficient evidence. The purpose of this study is aim to using Brain natriuretic peptide(BNP), echocardiography and speckle-tracking echocardiagraphy, six minutes walk test and quality of life to compare the changes of cardiac function within 1 month between LBBP and RVOP in pacemaker-dependent patients.
Read the detailed description
The purpose of this study was to compare the changes of cardiac function within 1month in pacemaker-dependent patients between LBBP and RVOP. A single-center prospective random controlled clinical study was conducted in 60 patients with bradycardia indications. 30 patients underwent RVOP and 30 patients underwent LBBP. The changes of BNP, echocardiogram and speckle-tracking echocardiagraphy, six minutes walk test and quality of life were compared between the two groups before and within 1month. The etiology of pacemaker implantation included high atrioventricular block, atrial fibrillation with slow arrhythmia. Implantation procedures: Left bundle branch pacing was achieved by trans-interventricular septum method in the basal ventricular septum and performed by using the Select pacing 3830 lead(Medtronic Inc, USA) delivered through a fixed sheath(7F C315 HIS, Medtronic Inc, USA). During implantation, a unipolar configuration is used for pacing and recording. The delivery sheath was inserted through left subclavian vein into atrial side of the tricuspid valve to mark His bundle potential under right anterior oblique(20°) fluoroscopic view. As a marker in His bundle region, the sheath with the lead tip was further advanced towards the right side of the ventricular septum approximately 1.5-2cm, and paced QRS morphology showing left bundle branch block(LBBB) at output of 2V/0.4ms. When the sheath with the lead tip screwed to the left side of the septum, paced QRS morphology changed from LBBB to right bundle branch block(RBBB), a gradual change of the notch morphology("W" waveform) in lead V1 gradually shifted and finally disappeared.Another active electrode is implanted in the right auricle.Patients with RVOP: The right ventricular pacing lead was positioned in the low intervals of right ventricular outflow tract, and atrial active lead was positioned at right auricle. BNP was measured routinely before implantation and reexamined on 1 day and 1month after pacemaker implantation.Twelve-lead ECG were recorded including QRS duration, QRS amplitude and QT interval. Echocardiography data were measured by conventional transthoracic echocardiography system including left atrial anteroposterior dimension, left atrial transverse dimension, left atrial vertical dimension, e', peak E-wave velocity, peak A-wave velocity, E/A, E/e', left atrial ejection fraction (LAEF), left ventricular ejection fraction (LVEF), velocity-time integration of aortic blood flow(VTI). Left atrial strain and strain rate were measured by speckle-tracking echocardiography(STE).We also measure the six minutes walk test and quality of life in all patients before and after implantation in 1month.
- Being tested
- pacemaker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacemakerDevice
electrode is implanted in left bundle branch in LBBP; electrode is implanted in right ventricular outflow tract septal in RVOP
| Study group | Role | What they receive |
|---|---|---|
| Left Bundle Branch Pacing | Not described Receives: Device: pacemaker | |
| Right Ventricular Outflow Tract Septal Pacing | Not described Receives: Device: pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in B natriuretic peptide
Blood samples are extracted in all patients to detected
Measured: baseline, 1 day and 1month after implantation
Changes in Electrocardiograph
QRS duration in ms, QT duration in ms
Measured: baseline, 1 day and 1 month after implantation
Changes of the Data of Pacemaker
Threshold value in V, sense in mV of the pacemaker
Measured: baseline and 1month after implantation
Changes of Ultrasonic Cardiogram
UCG:sizes of LA in mm
Measured: baseline, 7 days and 1 month after implantation
Changes of Ultrasonic Cardiogram
ejection fraction of LV and LA (%)
Measured: baseline, 7 days and 1 month after implantation
Changes of six minutes walk test
six minutes walk test in meter.
Measured: baseline, 7 days and 1 month after implantation
Changes of quality of life
SF-36 quality of life test.
Measured: baseline and 1 month after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Jan 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Slow Arrhythmia; Left Bundle Branch Pacing; Cardiac FunctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruiqin xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruiqin xie, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386473
- Sponsor's protocol ID
- XieruiqindoctorLBBP
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiac Function Between Left Bundle Branch Pacing and Right Ventricular Outflow Tract Septal Pacing in Pacemaker-dependent Patients
- ClinicalTrials.gov ID
- NCT04386473
- Acronym / sponsor ID
- XieruiqindoctorLBBP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ruiqin xieUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 13 May 2020 (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 a common method for bradycardia and cardiac conduction dysfunction. With the development of physiological pacing, the optimal location of ventricular pacing site is still improving. Traditional ventricular pacing site at the apex of right ventricle or septum of right ventricular outflow tract（RVOT）, causing iatrogenic left bundle branch block and asynchronous ventricular contraction, leading to cardiac remodeling, pacemaker-mediated cardiomyopathy and congestive cardiac failure. Long-term chronic ventricular pacing can lead to changes in endocardial myocytes and myofibrils and promote fibrosis. Thus, the alternative pacing site, HIS bundle pacing, has been sought later. The safety and feasibility of permanent HIS bundle pacing have been confirmed in patients with various cardiac diseases. However, the shortcomings of high and unstable threshold, long implantation time, low R-wave amplitude and HIS bundle damage during implantation limit the application of HIS pacing especially in patients with infra-Hisian block. Left bundle branch pacing(LBBP) is a new technique evolved from HIS bundle pacing. In 2017, Huang et al[9]reported that LBBP was successfully paced using 3830 leads(Medronic Inc. USA). The advantages of narrow QRS duration, low threshold, high R wave amplitude, easy fixation and correction of left bundle branch block made LBBP more widely used in clinic.However, whether left bundle branch pacing is superior to traditional right ventricular outflow tract septal pacing in cardial function is still lack of sufficient evidence. The purpose of this study is aim to using Brain natriuretic peptide(BNP), echocardiography and speckle-tracking echocardiagraphy, six minutes walk test and quality of life to compare the changes of cardiac function within 1 month between LBBP and RVOP in pacemaker-dependent patients.
Detailed description
The purpose of this study was to compare the changes of cardiac function within 1month in pacemaker-dependent patients between LBBP and RVOP. A single-center prospective random controlled clinical study was conducted in 60 patients with bradycardia indications. 30 patients underwent RVOP and 30 patients underwent LBBP. The changes of BNP, echocardiogram and speckle-tracking echocardiagraphy, six minutes walk test and quality of life were compared between the two groups before and within 1month. The etiology of pacemaker implantation included high atrioventricular block, atrial fibrillation with slow arrhythmia. Implantation procedures: Left bundle branch pacing was achieved by trans-interventricular septum method in the basal ventricular septum and performed by using the Select pacing 3830 lead(Medtronic Inc, USA) delivered through a fixed sheath(7F C315 HIS, Medtronic Inc, USA). During implantation, a unipolar configuration is used for pacing and recording. The delivery sheath was inserted through left subclavian vein into atrial side of the tricuspid valve to mark His bundle potential under right anterior oblique(20°) fluoroscopic view. As a marker in His bundle region, the sheath with the lead tip was further advanced towards the right side of the ventricular septum approximately 1.5-2cm, and paced QRS morphology showing left bundle branch block(LBBB) at output of 2V/0.4ms. When the sheath with the lead tip screwed to the left side of the septum, paced QRS morphology changed from LBBB to right bundle branch block(RBBB), a gradual change of the notch morphology("W" waveform) in lead V1 gradually shifted and finally disappeared.Another active electrode is implanted in the right auricle.Patients with RVOP: The right ventricular pacing lead was positioned in the low intervals of right ventricular outflow tract, and atrial active lead was positioned at right auricle. BNP was measured routinely before implantation and reexamined on 1 day and 1month after pacemaker implantation.Twelve-lead ECG were recorded including QRS duration, QRS amplitude and QT interval. Echocardiography data were measured by conventional transthoracic echocardiography system including left atrial anteroposterior dimension, left atrial transverse dimension, left atrial vertical dimension, e', peak E-wave velocity, peak A-wave velocity, E/A, E/e', left atrial ejection fraction (LAEF), left ventricular ejection fraction (LVEF), velocity-time integration of aortic blood flow(VTI). Left atrial strain and strain rate were measured by speckle-tracking echocardiography(STE).We also measure the six minutes walk test and quality of life in all patients before and after implantation in 1month.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left Bundle Branch Pacing | – | Device: pacemaker |
| Right Ventricular Outflow Tract Septal Pacing | – | Device: pacemaker |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pacemaker-dependent patients who agreed to implant a pacemaker.
Key inclusion criteria (1 listed)
- Pacemaker-dependent patients who agreed to implant a pacemaker.
Key exclusion criteria (1 listed)
- Patients with congenital heart diseases, such as atrial septal defect, ventricular septal defect, or rheumatic heart diseases, valvular heart diseases.
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 |
|---|---|---|
| pacemakerelectrode is implanted in left bundle branch in LBBP; electrode is implanted in right ventricular outflow tract septal in RVOP | Device | Left Bundle Branch Pacing, Right Ventricular Outflow Tract Septal Pacing |
Primary outcome
Changes in B natriuretic peptide
Time frame: baseline, 1 day and 1month after implantation
Blood samples are extracted in all patients to detected
Changes in Electrocardiograph
Time frame: baseline, 1 day and 1 month after implantation
QRS duration in ms, QT duration in ms
Changes of the Data of Pacemaker
Time frame: baseline and 1month after implantation
Threshold value in V, sense in mV of the pacemaker
Changes of Ultrasonic Cardiogram
Time frame: baseline, 7 days and 1 month after implantation
UCG:sizes of LA in mm
Changes of Ultrasonic Cardiogram
Time frame: baseline, 7 days and 1 month after implantation
ejection fraction of LV and LA (%)
Changes of six minutes walk test
Time frame: baseline, 7 days and 1 month after implantation
six minutes walk test in meter.
Changes of quality of life
Time frame: baseline and 1 month after implantation
SF-36 quality of life test.
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 5 May 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Slow Arrhythmia; Left Bundle Branch Pacing; Cardiac Function, run by Ruiqin xie 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: finished, as of the sponsor's last update on 5 May 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?
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?
Changes in B natriuretic peptide (time frame: baseline, 1 day and 1month after implantation). The study lists 7 primary outcomes in all. 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 5 May 2022.