Bradyarrhythmia
Conditions
Interventions
Experimental group:Use a guide sheath group to assist in performing atrial septal pacing with a wire-driven active lead.
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be over 18 years old; 2. All patients who are undergoing permanent cardiac pacemaker implantation for the first time and require implantation of atrial electrodes; 3. Willing to participate in the trial and sign the informed consent form; 4. Be willing and able to complete all visits at the research center;
Exclusion criteria
Exclusion criteria: 1. Persistent atrial fibrillation; 2. The diameter of the aortic sinus is greater than 40mm; 3. Patients who have undergone atrial septal occlusion or repair; 4. Anatomic abnormalities in the superior vena cava pathway; 5. Post-tricuspid valve surgery; 6. Severe hepatic and renal insufficiency within 14 days before surgery; 7. Known or suspected active systemic infection within 14 days before surgery; 8. Platelet count <50,000 cell/mm^3 within 14 days before surgery; 9. Participating in other clinical trials; 10. Life expectancy less than one year; 11. Pregnant and/or lactating women, or subjects who are expected to become pregnant during the study period; 12. Other individuals who, in the opinion of the researcher, are not suitable for participating in clinical trials;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of active helical electrode implantation in the right atrial septum.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of attempts and successful placements of atrial electrode implantation;Atrial active electrode parameters;The duration of the entire surgery, the time of X-ray exposure and the X-ray dose;Time of successful atrial electrode implantation, duration of X-ray exposure and X-ray dose;Cardiac function status: ultrasound, NYHA; | — |
Countries
China
Contacts
Public ContactSu Lan
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed