Outcome of Patients Undergoing Leadless Pacemaker Implantaton

NCT ID: NCT06656468

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2026-06-01

Brief Summary

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

Detailed Description

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

Conditions

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Bradyarrhythmias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Leadless pacemaker patients

Consecutive patients undergoing leadless pacemaker patients

Pacemaker and defibrillator

Intervention Type DEVICE

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

Interventions

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Pacemaker and defibrillator

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* inability to sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Cardinale G. Panico

OTHER

Sponsor Role lead

Responsible Party

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Pietro Palmisano

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliera "Card. G. Panico"

Tricase, , Italy

Site Status

Countries

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Italy

References

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Palmisano P, Facchin D, Ziacchi M, Nigro G, Nicosia A, Bongiorni MG, Tomasi L, Rossi A, De Filippo P, Sgarito G, Verlato R, Di Silvestro M, Iacopino S. Rate and nature of complications with leadless transcatheter pacemakers compared with transvenous pacemakers: results from an Italian multicentre large population analysis. Europace. 2023 Feb 8;25(1):112-120. doi: 10.1093/europace/euac112.

Reference Type BACKGROUND
PMID: 36036679 (View on PubMed)

Other Identifiers

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OPUPI registry

Identifier Type: -

Identifier Source: org_study_id

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