Bradyarrhythmia
Conditions
Interventions
Observation Group:None
Sponsors
Shanxi Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Met the indication of pacemaker implantation; 2. Initial implantation or replacement with a study device; 3. Age>=18 years; 4. Willing to participate in the trial and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Presence of other cardiac rhythm management devices, components, or accessories; 2. Females who are planning pregnancy, are pregnant, or are lactating; 3. Diagnosis of severe tricuspid valve disease or implantation of a mechanical prosthetic tricuspid valve; 4. Planned cardiothoracic surgery or recipient of a heart transplantation during the follow-up period; 5. Life expectancy of less than 12 months; 6. Concurrent participation in other investigational drug or device clinical trials; 7. Deemed by the investigator as unsuitable for participation in this trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of AF at 1 year after pacemaker implantation;Prevalence of severe sleep apnea at 1 year after pacemaker implantation;Incidence of adverse events and device defects;Correlation between severe sleep apnea at 90 days after pacemaker implantation and atrial fibrillation at 1 year; | — |
Secondary
| Measure | Time frame |
|---|---|
| To analyze the influencing factors of atrial fibrillation at 1 year after cardiac pacemaker implantation;To analyze the influencing factors of severe sleep apnea within 1 year after cardiac pacemaker implantation;Compared with the gold standard PSG monitoring, SAM function in the diagnosis of different degrees of sleep apnea, sensitivity and specificity; | — |
Countries
China
Contacts
Public ContactWang Haixiong
Shanxi Cardiovascular Hospital
Outcome results
None listed