Change of QRS Morphology and Electrophysiological Characteristics During Pacing Within the Interventricular Septum

NCT ID: NCT05557006

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-27

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Pacing

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

Patients who meet the inclusion criteria

left bundle branch pacing

Intervention Type PROCEDURE

In the procedure of left bundle branch pacing, various QRS morphologies are observed as penetrating the lead into the interventricular septum.

Interventions

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left bundle branch pacing

In the procedure of left bundle branch pacing, various QRS morphologies are observed as penetrating the lead into the interventricular septum.

Intervention Type PROCEDURE

Eligibility Criteria

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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%.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Shenyang Military Region

OTHER

Sponsor Role lead

Responsible Party

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Yanchun Liang

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanchun Liang, MD、PhD

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of Northern Theater Command

Locations

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General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanchun Liang, MD、PhD

Role: CONTACT

+86-13309886380

Facility Contacts

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Yanchun Liang, MD、PhD

Role: primary

+86-13309886380

References

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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.

Reference Type BACKGROUND
PMID: 34662435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33390564 (View on PubMed)

Other Identifiers

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GHNTC-PACE

Identifier Type: -

Identifier Source: org_study_id

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