- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05557006
Change of QRS Morphology and Electrophysiological Characteristics During Pacing Within the Interventricular Septum
March 15, 2023 updated by: Yanchun Liang, General Hospital of Shenyang Military Region
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yanchun Liang, MD、PhD
- Phone Number: +86-13309886380
- Email: liangyanchun@sina.com
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110016
- Recruiting
- General Hospital of Northern Theater Command
-
Contact:
- Yanchun Liang, MD、PhD
- Phone Number: +86-13309886380
- Email: liangyanchun@sina.com
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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%.
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: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
All patients
Patients who meet the inclusion criteria
|
In the procedure of left bundle branch pacing, various QRS morphologies are observed as penetrating the lead into the interventricular septum.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
|
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.
|
Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
|
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.
|
Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stimulus-QRSend duration (s-QRSend)
Time Frame: Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
|
Stimulus-QRSend duration (s-QRSend) is the time from the onset of the pacing stimulus to the end of QRS complex.
|
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 late-R wave duration in lead V1 indicates delayed right ventricular excitation.
|
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.
|
The S wave duration in lead V6 indicates delayed right ventricular excitation.
|
Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yanchun Liang, MD、PhD, The General Hospital of Northern Theater Command
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Zhang 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.
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)
September 27, 2022
Primary Completion (Anticipated)
May 1, 2024
Study Completion (Anticipated)
May 1, 2024
Study Registration Dates
First Submitted
September 19, 2022
First Submitted That Met QC Criteria
September 22, 2022
First Posted (Actual)
September 27, 2022
Study Record Updates
Last Update Posted (Actual)
March 16, 2023
Last Update Submitted That Met QC Criteria
March 15, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GHNTC-PACE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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