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

Sun Yat-sen University

Status: Enrolling

Conditions: Pacemaker Complication; Complication of Surgical Procedure; Pacemaker Syndrome

Treatments: Device: Leadless pacemaker

Study type: Observational

Funder types: Other

Identifiers

NCT05761821

SYSKY-2023-056-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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