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NCT04926792 Clinical Trial

Taiwan Registry for Leadless Pacemaker

Atrioventricular Block Clinical Trial

Official title:
Taiwan Registry for Leadless Pacemaker

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04926792
Other study ID # 202103105RINB
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 19, 2022
Est. completion date December 31, 2024

Study information
Verified date April 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 300
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. The patients who had successfully received leadless pacemaker implantation 2. The patients who attempt to receive leadless pacemaker implantation Exclusion Criteria: N/A

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Leadless Pacemaker
Leadless pacemaker implantation

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (3)
Lead Sponsor Collaborator
National Taiwan University Hospital Chang Gung Memorial Hospital, Taiwan Society of Cardiology

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute complication Any acute complication during procedure On the 1 day of implant procedure
Primary Subacute complication Any subacute complication, including pacemaker syndrome within 3 month after implant procedure
Primary Leadless Pacemaker performance The AV synchrony or pacemaker parameters aroung 12 months after implant proceure
Secondary Successful implant The attempts of deployment in one procedure 1 day
See also
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Completed NCT02154750 - AV Delay Optimization vs. Intrinsic Conduction in Pacemaker Patients With Long PR Intervals N/A
Completed NCT02198781 - Right Ventricle (RV) Markers of Future Pacing Induced Ventricular Dysfunction - Pilot
Recruiting NCT01477138 - RV Septal Versus Minimized RV Pacing in Sick Sinus Syndrome N/A
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Completed NCT00161538 - Pacing of the Atria in Sick Sinus Syndrome Trial Preventive Strategies for Atrial Fibrillation Phase 4