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

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05761821
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 11.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Complication of Surgical Procedure; Pacemaker Complication; Pacemaker Syndrome	Device: Leadless pacemaker

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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Relationship Between Key Factors of Leadless Pacemaker Implantation With Implantation Site, Intraoperative Complications and Prognosis
• Actual Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Outcome Measures

Primary Outcome Measures

1. Serious adverse events [Day 0 (Time of implantation)-Day 7]

   including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection

Secondary Outcome Measures

1. Device-related complications [Day 0 (Time of implantation)-Day 7]

   Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous fistula, tricuspid valve injury

2. Device-related complications [Day 0 (Time of implantation)-Year 2]

   Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous

3. Serious adverse events [Day 0 (Time of implantation)-Year 2]

   including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection

4. Re-intervention of devices [Day 0 (Time of implantation)-Year 2]

   extraction, re-implantation, or implantation of traditional transvenous pacemaker

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

• Principal Investigator: Yangxin Chen, PhD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yangxin Chen, Chief physician, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT05761821
• Other Study ID Numbers: SYSKY-2023-056-01
• First Posted: Mar 9, 2023
• Last Update Posted: Mar 9, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yangxin Chen, Chief physician, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: leadless pacemaker; complication; Prognosis

Study Results

No Results Posted as of Mar 9, 2023