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

NCT05557006 | Unknown

• 1 other identifier: GHNTC-PACE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Left Bundle Branch Pacing; Left Bundle Branch Area Pacing; Septal Pacing; Left Ventricular Activation Time; Right Ventricular Activation Time

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.

Secondary Outcomes (3)

• Stimulus-QRSend duration (s-QRSend)

  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)

  Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.

• The S wave duration and amplitude in lead V6 (Sdur、Samp)

  Continuous uninterrupted monitoring during the lead penetration into the interventricular septum.

Study Arms (1)

All patients

Patients who meet the inclusion criteria

Procedure: left bundle branch pacing

Interventions

left bundle branch pacing PROCEDURE

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

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 34662435 BACKGROUND

• 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.

  PMID: 33390564 BACKGROUND

Study Officials

• Yanchun Liang, MD、PhD

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanchun Liang, MD、PhD

CONTACT

+86-13309886380; liangyanchun@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 27, 2022
• Study Start: September 27, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

CN (1)