- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04386473
Comparison of Cardiac Function Between Left Bundle Branch Pacing and Right Ventricular Outflow Tract Septal Pacing in Pacemaker-dependent Patients
May 4, 2022 updated by: Ruiqin xie
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China
- Second Hospital of Hebei Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 98 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Pacemaker-dependent patients who agreed to implant a pacemaker.
Description
Inclusion Criteria:
Pacemaker-dependent patients who agreed to implant a pacemaker.
Exclusion Criteria:
Patients with congenital heart diseases, such as atrial septal defect, ventricular septal defect, or rheumatic heart diseases, valvular heart diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Left Bundle Branch Pacing
|
electrode is implanted in left bundle branch in LBBP; electrode is implanted in right ventricular outflow tract septal in RVOP
|
Right Ventricular Outflow Tract Septal Pacing
|
electrode is implanted in left bundle branch in LBBP; electrode is implanted in right ventricular outflow tract septal in RVOP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in B natriuretic peptide
Time Frame: baseline, 1 day and 1month after implantation
|
Blood samples are extracted in all patients to detected
|
baseline, 1 day and 1month after implantation
|
Changes in Electrocardiograph
Time Frame: baseline, 1 day and 1 month after implantation
|
QRS duration in ms, QT duration in ms
|
baseline, 1 day and 1 month after implantation
|
Changes of the Data of Pacemaker
Time Frame: baseline and 1month after implantation
|
Threshold value in V, sense in mV of the pacemaker
|
baseline and 1month after implantation
|
Changes of Ultrasonic Cardiogram
Time Frame: baseline, 7 days and 1 month after implantation
|
UCG:sizes of LA in mm
|
baseline, 7 days and 1 month after implantation
|
Changes of Ultrasonic Cardiogram
Time Frame: baseline, 7 days and 1 month after implantation
|
ejection fraction of LV and LA (%)
|
baseline, 7 days and 1 month after implantation
|
Changes of six minutes walk test
Time Frame: baseline, 7 days and 1 month after implantation
|
six minutes walk test in meter.
|
baseline, 7 days and 1 month after implantation
|
Changes of quality of life
Time Frame: baseline and 1 month after implantation
|
SF-36 quality of life test.
|
baseline and 1 month after implantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
December 1, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
May 6, 2020
First Submitted That Met QC Criteria
May 12, 2020
First Posted (Actual)
May 13, 2020
Study Record Updates
Last Update Posted (Actual)
May 5, 2022
Last Update Submitted That Met QC Criteria
May 4, 2022
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XieruiqindoctorLBBP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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