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

Complication of Surgical Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761821
• Other study ID #: SYSKY-2023-056-01
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yangxin Chen, PhD
• Phone: +8602081332360
• Email: chenyx39[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Pacemaker Complication

Intervention

Device:
• Leadless pacemaker
All enrolled patients were implanted with leadless pacemaker.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

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