Comparison of Cardiac Function Between Left Bundle Branch Pacing and Right Ventricular Outflow Tract Septal Pacing in Pacemaker-dependent Patients

NCT04386473 | Completed FDA Device

• 1 other identifier: XieruiqindoctorLBBP
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Slow Arrhythmia; Left Bundle Branch Pacing; Cardiac Function

Outcome Measures

Primary Outcomes (7)

• Changes in B natriuretic peptide

  Blood samples are extracted in all patients to detected

  baseline, 1 day and 1month after implantation

• Changes in Electrocardiograph

  QRS duration in ms, QT duration in ms

  baseline, 1 day and 1 month after implantation

• Changes of the Data of Pacemaker

  Threshold value in V, sense in mV of the pacemaker

  baseline and 1month after implantation

• Changes of Ultrasonic Cardiogram

  UCG:sizes of LA in mm

  baseline, 7 days and 1 month after implantation

• Changes of Ultrasonic Cardiogram

  ejection fraction of LV and LA (%)

  baseline, 7 days and 1 month after implantation

• Changes of six minutes walk test

  six minutes walk test in meter.

  baseline, 7 days and 1 month after implantation

• Changes of quality of life

  SF-36 quality of life test.

  baseline and 1 month after implantation

Study Arms (2)

Left Bundle Branch Pacing

Device: pacemaker

Right Ventricular Outflow Tract Septal Pacing

Device: pacemaker

Interventions

pacemaker DEVICE

electrode is implanted in left bundle branch in LBBP; electrode is implanted in right ventricular outflow tract septal in RVOP

Left Bundle Branch Pacing; Right Ventricular Outflow Tract Septal Pacing

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pacemaker-dependent patients who agreed to implant a pacemaker.

You may qualify if:

• Pacemaker-dependent patients who agreed to implant a pacemaker.

You may not qualify if:

• Patients with congenital heart diseases, such as atrial septal defect, ventricular septal defect, or rheumatic heart diseases, valvular heart diseases.

Sponsors & Collaborators

• Ruiqin xie: lead

Study Sites (1)

Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of cardiology department

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 13, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 5, 2022

Record last verified: 2020-05

Locations

CN (1)