NCT05761821

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 9, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

February 27, 2023

Last Update Submit

February 27, 2023

Conditions

Complication of Surgical ProcedurePacemaker ComplicationPacemaker Syndrome

Keywords

leadless pacemakercomplicationPrognosis

Outcome Measures

Primary Outcomes (1)

  • Serious adverse events

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

    Day 0 (Time of implantation)-Day 7

Secondary Outcomes (4)

  • Device-related complications

    Day 0 (Time of implantation)-Day 7

  • Device-related complications

    Day 0 (Time of implantation)-Year 2

  • Serious adverse events

    Day 0 (Time of implantation)-Year 2

  • Re-intervention of devices

    Day 0 (Time of implantation)-Year 2

Interventions

Leadless pacemakerDEVICE

All enrolled patients were implanted with leadless pacemaker.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients received implantation of leadless pacemaker

You may qualify if:

  • Patient received implantation of leadless pacemaker
  • Patient agreed to join into this study and signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Study Officials

  • Yangxin Chen, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yangxin Chen, PhD

CONTACT

+8602081332360chenyx39@mail.sysu.edu.cn

Qi Guo, MD

CONTACT

+8602081332360guoq69@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 9, 2023

Study Start

October 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 9, 2023

Record last verified: 2023-02

Locations

CN(1)