Outcome of Patients Undergoing Leadless Pacemaker Implantaton

• Conditions: Bradyarrhythmias

• Registration Number: NCT06656468
• Lead Sponsor: Azienda Ospedaliera Cardinale G. Panico

Brief Summary

Observational study aimed to evaluate the rate and of complications related to lealdless pacemaker implantation.

Detailed Description

Observational, multicenter study enrolling consecutive patients undergoing leadless pacemaker implantation. Procedure details, intraprocedural complications, and n-hospital outcomes will be recorded.

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-22
• Last Update Submitted: 2024-10-22
• Study First Posted: 2024-10-24
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• patients with indication for leadless pacemaker implantation according to current Guidelines on cardiac pacing.

Exclusion Criteria

• inability to sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute complications	From date of implantation until the date of first documented complication, assessed up to 30 days.	Acute complications related to leadless pacemaker implantation

Secondary Outcome Measures

Name	Time	Method
Long-term complications	From 31th day from implantation until the date of first documented complication, assessed up to 6 months.	Complications related to leadless pacemaker implantation observed during long-term follow-up

Trial Locations

Locations (1)

Azienda Ospedaliera "Card. G. Panico"; 🇮🇹 Tricase, Italy