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

G

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status

Enrolling

Conditions

Cardiac Pacing

Treatments

Procedure: left bundle branch pacing

Study type

Observational

Funder types

Other

Identifiers

NCT05557006
GHNTC-PACE

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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%.

Trial design

50 participants in 1 patient group

All patients
Description:
Patients who meet the inclusion criteria
Treatment:
Procedure: left bundle branch pacing

Trial contacts and locations

1

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Central trial contact

Yanchun Liang, MD、PhD

Data sourced from clinicaltrials.gov

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