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Single-center clinical study for the efficacy and safety of left bundle branch region pacing

Single-center clinical study for the efficacy and safety of left bundle branch region pacing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020104
Enrollment
Unknown
Registered
2018-12-14
Start date
2018-12-17
Completion date
Unknown
Last updated
2018-12-18

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

Conditions

Bradycardia

Interventions

Group 1:LBBP
Group 2:RVSP

Sponsors

Xiamen Cardiovascular Hospital, Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Confirmation of bradycardia and in line with the recommendations of the Chinese Medical Association Electrophysiological and Pacing Branch on implantable cardiac pacemakers (2010 edition) Permanent pacing indications I, IIa, IIb indications a. Sick sinus syndrome accompanied with related symptoms; b. Irreversible atrioventricular block: including II degree II and III degree atrioventricular block with or without symptoms; II degree type I atrioventricular block with associated symptoms c. Three-branch block with syncope or intermittent second degree atrioventricular block, alternating bundle branch block (2) LVEF>40%; (3) signing an informed consent form;

Exclusion criteria

Exclusion criteria: (1) pregnant and lactating women (2) Age less than 18 or greater than 80 years old; (3) Those whose life expectancy is shorter than 2 years; (4) severe liver and kidney dysfunction; (5) Patients undergoing valve replacement, CABG, PCI or myocardial angioplasty and presence of acute myocardial infarction within 6 weeks prior to enrollment (6) Those with CRT or ICD indications (7) Cannot participate in follow-up; (8) moderate to severe valvular regurgitation or ventricular aneurysm due to old myocardial infarction

Design outcomes

Primary

MeasureTime frame
Pacing QRS interval;Tmsv-16-SD;LVEF;Classification of NYHA heart function;Admittted to hospital due to heart failure;All cause death;Upgrade to CRT;Pacing threshold;Sensing;Impedance;

Secondary

MeasureTime frame
Pacing ECG axis;AV-PV;IVS-RV;LVS-LVPWD;LLW-RVFW;SV;MR;TR;LVD;NT-proBNP;

Countries

China

Contacts

Public ContactCai Binni

Xiamen Cardiovascular Hospital, Xiamen University

1140853669@qq.com+86 13306042816

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026