Outcome of Patients Undergoing Leadless Pacemaker Implantaton

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

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Key information

Conditions

Bradyarrhythmias Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera "Card. G. Panico"

Tricase, 73039, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

inability to sign informed consent

Treatment and study plan

Pacemaker and defibrillator

Device

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

Primary outcomes

Acute complications

Time frame: From date of implantation until the date of first documented complication, assessed up to 30 days.

Acute complications related to leadless pacemaker implantation

Secondary outcomes

Long-term complications

Time frame: 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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Cardinale G. Panico

Other

Registry information

Acronym: OPUPI

Important dates

Study start: 2019
Primary completion: 2025
Study completion: 2026
First posted: Oct 24, 2024
Registry last updated: Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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