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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05600699
Enrollment
136
Registered
2022-10-31
Start date
2018-04-01
Completion date
2022-10-01
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrioventricular Block, Left Bundle Branch Pacing

Brief summary

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.

Detailed description

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.

Interventions

DEVICECardiac pacemaker and Select Secure lead

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

Sponsors

Linyi People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in left atrium diameter at 3 yearsBaseline and 3 yearsEchocardiography is measured by a professional using an ultrasound machine, record the following results: left atrium diameter (ms)
Change from Baseline in left ventricular end diastolic diameter at 3 yearsBaseline and 3 yearsLeft ventricular end diastolic diameter (ms)
Change from Baseline in left ventricular ejection fraction at 3 yearsBaseline and 3 yearsLeft ventricular ejection fraction (%)
Change from Baseline in pulmonary artery systolic pressure at 3 yearsBaseline and 3 yearsPulmonary artery systolic pressure (mmHg)

Secondary

MeasureTime frameDescription
Change from Baseline in threshold at 3 yearsBaseline and 3 yearsThreshold was measured with a pace-sensing analyser: threshold (V) at 0.5ms
Change from Baseline in impedance at 3 yearsBaseline and 3 yearsImpedance was measured with a pace-sensing analyser: impedance(Ω)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026