Bradyarrhythmia
Conditions
Interventions
Experimental group:Use the guide sheath group to assist the active wire driven for pacing in the left bundle branch area
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years; 2. All patients experiencing chronic arrhythmias who are undergoing their first permanent cardiac pacemaker implantation and require ventricular electrode implantation; 3. Willing to participate in the trial and sign the informed consent form; 4. Willing and able to complete all visits at the research centre.
Exclusion criteria
Exclusion criteria: 1. Hypertrophic cardiomyopathy, or interventricular septum thickness >=15mm or <=6mm; 2. Patients with echocardiographic LVEF <50% or systolic heart dysfunction; 3. Patients who have undergone ventricular septal defect closure or repair; 4. Anatomical abnormalities of the superior vena cava pathway; 5. Severe tricuspid valve disease, including severe tricuspid stenosis, severe tricuspid regurgitation, tricuspid valve prolapse, or post-tricuspid valve repair; 6. Severe liver or kidney dysfunction within 14 days prior to surgery; 7. Known or suspected active systemic infection within 14 days prior to surgery; 8. Platelet count <50,000 cells/mm^3 within 14 days prior to surgery; 9. Currently participating in other clinical trials; 10. Expected life expectancy less than one year; 11. Pregnant and/or breastfeeding women, or subjects planning to become pregnant during the study period; 12. Other conditions deemed by the investigator to be unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of transvenous introduction of active electrodes implanted in the left bundle branch region in patients with bradyarrhythmia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of attempts and positioning for successful implantation of left bundle branch region electrodes;Left bundle branch region active electrode parameters;Total duration of the surgery, X-ray exposure time and X-ray dose;Time of successful implantation of left bundle branch area electrode, X-ray exposure time and X-ray dose;Cardiac function: ultrasound, NYHA; | — |
Countries
China
Contacts
Public ContactSu Lan
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed