Key Factors of Leadless Pacemaker Implantation With Impla... | NCT05761821

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

NCT05761821

Sponsor

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

Status

Unknown status

Last Update Posted

Mar 9, 2023Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Complication of Surgical Procedure
Pacemaker Complication
Pacemaker Syndrome

Interventions

Leadless pacemaker

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Feb 27, 2023

First Submission Date that Met QC Criteria

Feb 27, 2023

First Posted Date

Mar 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2023

Last Update Posted Date

Mar 9, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yangxin Chen, Chief physician, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Leadless pacemaker	Device	All enrolled patients were implanted with leadless pacemaker.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Device-related complications	Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous fistula, tricuspid valve injury	Day 0 (Time of implantation)-Day 7
Device-related complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients received implantation of leadless pacemaker

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yangxin Chen, PhD	Contact	+8602081332360		chenyx39@mail.sysu.edu.cn
Qi Guo, MD	Contact	+8602081332360		guoq69@mail.sysu.edu.cn

Overall Officials

Name	Affiliation	Role
Yangxin Chen, PhD	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided