Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis

Study Overview
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Brief Summary
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To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.

Detailed Description
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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.

Official Title
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Relationship Between Key Factors of Leadless Pacemaker Implantation With Implantation Site, Intraoperative Complications and Prognosis

Conditions
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Complication of Surgical Procedure, Pacemaker Complication, Pacemaker Syndrome

Intervention / Treatment
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* Device: Leadless pacemaker


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Leadless pacemaker|All enrolled patients were implanted with leadless pacemaker.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse events | including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection | Day 0 (Time of implantation)-Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related complications | Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous fistula, tricuspid valve injury | Day 0 (Time of implantation)-Day 7 | 
| Device-related complications | Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous | Day 0 (Time of implantation)-Year 2 | 
| Serious adverse events | including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection | Day 0 (Time of implantation)-Year 2 | 
| Re-intervention of devices | extraction, re-implantation, or implantation of traditional transvenous pacemaker | Day 0 (Time of implantation)-Year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leadless pacemaker, complication, Prognosis