Taiwan Registry for Leadless Pacemaker | NCT04926792

Studies
Taiwan Registry for Leadless Pacemaker

NCT04926792

Sponsor

National Taiwan University Hospital

Status

Enrolling by invitation

Last Update Posted

Jan 8, 2026Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Sick Sinus Syndrome
Atrioventricular Block

Interventions

Leadless Pacemaker

Countries

Taiwan

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

Jan 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 2022Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Jun 9, 2021

First Submission Date that Met QC Criteria

Jun 14, 2021

First Posted Date

Jun 15, 2021Actual

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

Jan 6, 2026

Last Update Posted Date

Jan 8, 2026Actual

Name	Class
Taiwan Society of Cardiology	UNKNOWN
Chang Gung Memorial Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Taiwan Registry for Leadless Pacemaker is a nationwide registry for leadless pacemaker performance in Taiwan.

Detailed Description

The purpose of this registry is to investigate the safety and efficiency performance of the leadless pacemakers in Taiwan. The registry will collect all the information about the patient selection, implantation procedure, and follow up parameters of the leadless pacemakers to evaluate the real-world benefit specifically in Taiwan population.

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

Name	Type	Description	Arm Group Labels	Other Names
Leadless Pacemaker	Device	Leadless pacemaker implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute complication	Any acute complication during procedure	On the 1 day of implant procedure
Subacute complication	Any subacute complication, including pacemaker syndrome	within 3 month after implant procedure
Leadless Pacemaker performance	The AV synchrony or pacemaker parameters	aroung 12 months after implant proceure

Secondary Outcomes

Measure	Description	Time Frame
Successful implant	The attempts of deployment in one procedure	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients who had successfully received leadless pacemaker implantation
The patients who attempt to receive leadless pacemaker implantation

Exclusion Criteria:

N/A

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

who attempt or had successfully received a leadless pacemaker implantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chih-Chieh Yu, MD.PhD	Taiwan Society of Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012804	Sick Sinus Syndrome
D054537	Atrioventricular Block

Ancestor Terms

ID	Term
D001146	Arrhythmia, Sinus
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided