Outcome of Patients Undergoing Leadless Pacemaker Implantaton (OPUPI)

October 22, 2024 updated by: Pietro Palmisano, Azienda Ospedaliera Cardinale G. Panico
Observational study aimed to evaluate the rate and of complications related to lealdless pacemaker implantation.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Tricase, Italy, 73039
        • Azienda Ospedaliera "Card. G. Panico"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with indication for leadless pacemaker implantation for symptomatic bradyarrhythmias according to current Guidelines on cardiac pacing.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • inability to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Leadless pacemaker patients
Consecutive patients undergoing leadless pacemaker patients
Device: Pacemaker and defibrillator
Leadless pacemaker implantation procedure performed accordng to usual clinical practice. The indication for pacemaker implantation will be based on current guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of implantation until the date of first documented complication, assessed up to 30 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From 31th day from implantation until the date of first documented complication, assessed up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Cardinale G. Panico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPUPI registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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