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Completed

NCT Number: NCT05600699

Long-term Efficacy and Safety Research of Left Bundle Branch Pacing

Patients with successful left bundle branch pacing in our center were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. According to whether or not a potential was recorded and the specific potential characteristics at implantation, the patients were divided into 3 groups: left bundle branch potential group; Purkinje potential group; and no-potential group. During the 3 years follow-up, the investigators collected the ECG、UCG and pacemaker parameters to analyze.

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Key information

Conditions

Atrioventricular Block Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Left Bundle Branch Pacing Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Linyi People's Hospital

Linyi, Shandong, 276000, China

About this study

A total of 136 patients with a high percentage of ventricular pacing and successful left bundle branch pacing were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. According to whether or not a potential was recorded and the specific potential characteristics at implantation, the patients were divided into 3 groups: left bundle branch potential group (L group) 31.6%; Purkinje potential group (P group) 10.3%; and no-potential group (N group) 58.1%. During the 3 years follow-up, the investigators collected the ECG、UCG and pacemaker parameters to analyze.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who were predicted to require a high percentage of ventricular pacing in our center were enrolled in this study

Exclusion criteria

  • Low rate of pacing, and loss to follow-up

Treatment and study plan

Cardiac pacemaker and Select Secure lead

Device

model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA

Primary outcomes

  1. Change from Baseline in left atrium diameter at 3 years

    Time frame: Baseline and 3 years

    Echocardiography is measured by a professional using an ultrasound machine, record the following results: left atrium diameter (ms)

  2. Change from Baseline in left ventricular end diastolic diameter at 3 years

    Time frame: Baseline and 3 years

    Left ventricular end diastolic diameter (ms)

  3. Change from Baseline in left ventricular ejection fraction at 3 years

    Time frame: Baseline and 3 years

    Left ventricular ejection fraction (%)

  4. Change from Baseline in pulmonary artery systolic pressure at 3 years

    Time frame: Baseline and 3 years

    Pulmonary artery systolic pressure (mmHg)

Secondary outcomes

  1. Change from Baseline in threshold at 3 years

    Time frame: Baseline and 3 years

    Threshold was measured with a pace-sensing analyser: threshold (V) at 0.5ms

  2. Change from Baseline in impedance at 3 years

    Time frame: Baseline and 3 years

    Impedance was measured with a pace-sensing analyser: impedance(Ω)

Sponsors and collaborators

Lead sponsor

Linyi People's Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Oct 31, 2022
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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