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Outcome of Patients Undergoing Leadless Pacemaker Implantaton

Outcome of Patients Undergoing Leadless Pacemaker Implantaton

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06656468
Acronym
OPUPI
Enrollment
900
Registered
2024-10-24
Start date
2019-09-01
Completion date
2026-06-01
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradyarrhythmias

Keywords

Bradyarrhythmias, leadless pacemaker, complications

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.

Interventions

Leadless pacemaker implantation procedure performed accordng to usual clinical practice. The indication for pacemaker implantation will be based on current guidelines.

Sponsors

Azienda Ospedaliera Cardinale G. Panico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* inability to sign informed consent

Design outcomes

Primary

MeasureTime frameDescription
Acute complicationsFrom date of implantation until the date of first documented complication, assessed up to 30 days.Acute complications related to leadless pacemaker implantation

Secondary

MeasureTime frameDescription
Long-term complicationsFrom 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026