An observational study in Atrioventricular Block and Left Bundle Branch Pacing, sponsored by Linyi People's Hospital. Completed at 1 site in China. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-11-01.
Sponsored by Linyi People's Hospital · Observational
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.
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.
109 studies on the registry are indexed under Atrioventricular Block; 39 are open to participants now.
This study's enrollment of 136 is below the median of 300 across 31 observational studies indexed under Atrioventricular Block.
Browse Atrioventricular Block studies →Linyi People's Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
From April 2018 to Dec 2019, consecutive patients who were predicted to require a high percentage of ventricular pacing in our center were enrolled in this study. Main indications for the enrolment of patients are atrioventricular block and heart failure (HF) combined with complete left bundle branch block (LBBB). All patients were accorded with indications for pacing therapy of 2013 European Society of Cardiology guidelines on cardiac pacing. The study conforms to the guiding principles of the Declaration of Helsinki and was approved by Ethics Committee of the Linyi People's Hospital. All patients signed the informed consent.
Exclusion Criteria:
the left bundle branch potential was recorded at implantation
Device: Cardiac pacemaker and Select Secure lead
the purkinje potential was recorded at implantation
Device: Cardiac pacemaker and Select Secure lead
no potential was recorded at implantation
Device: Cardiac pacemaker and Select Secure lead
model 3830, 69cm, Medtronic, Inc., Minneapolis, MN, USA
Change from Baseline in left atrium diameter at 3 years
Echocardiography is measured by a professional using an ultrasound machine, record the following results: left atrium diameter (ms)
Time frame: Baseline and 3 years
Change from Baseline in left ventricular end diastolic diameter at 3 years
Left ventricular end diastolic diameter (ms)
Time frame: Baseline and 3 years
Change from Baseline in left ventricular ejection fraction at 3 years
Left ventricular ejection fraction (%)
Time frame: Baseline and 3 years
Change from Baseline in pulmonary artery systolic pressure at 3 years
Pulmonary artery systolic pressure (mmHg)
Time frame: Baseline and 3 years
Change from Baseline in threshold at 3 years
Threshold was measured with a pace-sensing analyser: threshold (V) at 0.5ms
Time frame: Baseline and 3 years
Change from Baseline in impedance at 3 years
Impedance was measured with a pace-sensing analyser: impedance(Ω)
Time frame: Baseline and 3 years
Plan to share: Undecided — all collected IPD would be shared after publishing
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Linyi People's Hospital