Taiwan Registry for Leadless Pacemaker

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04926792
• Collaborator: Taiwan Society of Cardiology (Other), Chang Gung Memorial Hospital (Other)
• Enrollment: 300
• Anticipated Duration (Months): 47

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Performance of the Leadless Pacemaker in Taiwan Population	Device: Leadless Pacemaker

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Taiwan Registry for Leadless Pacemaker
• Anticipated Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Outcome Measures

Primary Outcome Measures

1. Acute complication [On the 1 day of implant procedure]

   Any acute complication during procedure

2. Subacute complication [within 3 month after implant procedure]

   Any subacute complication, including pacemaker syndrome

3. Leadless Pacemaker performance [aroung 12 months after implant proceure]

   The AV synchrony or pacemaker parameters

Secondary Outcome Measures

1. Successful implant [1 day]

   The attempts of deployment in one procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Taiwan University Hospital
• Taiwan Society of Cardiology
• Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT04926792
• Other Study ID Numbers: 202103105RINB
• First Posted: Jun 15, 2021
• Last Update Posted: Jun 15, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by National Taiwan University Hospital: Leadless Pacemaker; Taiwan

Study Results

No Results Posted as of Jun 15, 2021