Complication of Surgical Procedure, Pacemaker Complication, Pacemaker Syndrome
Conditions
Keywords
leadless pacemaker, complication, Prognosis
Brief summary
To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.
Detailed description
In this study, we aim to include patients implated with leadless pacemakers, collect key variables and other clinical data during implantation of leadless pacemakers, and observe the final implantation site, intraoperative complications and prognosis information of patients. This study aims to clarify the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis, and provide data support for the standardization of leadless pacemaker implantation process in China.
Interventions
DEVICELeadless pacemaker
All enrolled patients were implanted with leadless pacemaker.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient received implantation of leadless pacemaker * Patient agreed to join into this study and signed informed consent
Exclusion criteria
* Age \< 18 years * Ventricular septal defect * History of mechanical tricuspid valve replacement * History of inferior vena cava filter placement * Pregnant or plan to be pregnant within 2 years * Life expectancy \< 1 year * Patient was included in other studies that could introduce bias into this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events | Day 0 (Time of implantation)-Day 7 | including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-related complications | Day 0 (Time of implantation)-Day 7 | Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous fistula, tricuspid valve injury |
| Serious adverse events | Day 0 (Time of implantation)-Year 2 | including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection |
| Re-intervention of devices | Day 0 (Time of implantation)-Year 2 | extraction, re-implantation, or implantation of traditional transvenous pacemaker |
Countries
China
Contacts
Primary ContactYangxin Chen, PhD
Backup ContactQi Guo, MD
Outcome results
None listed