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

Recruiting

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

• Registration Number: NCT05761821
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Last Update Submitted: 2023-02-27
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serious adverse events	Day 0 (Time of implantation)-Day 7	including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection

Secondary Outcome Measures

Name	Time	Method
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
Device-related complications	Day 0 (Time of implantation)-Year 2	Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China