Enrolling by invitation NCT06656468
Outcome of Patients Undergoing Leadless Pacemaker Implantaton
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pacemaker and defibrillator.
- Who it may be relevant to
- Registry conditions: Bradyarrhythmias. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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.
Primary outcome measures
- Acute complications [Time frame: From date of implantation until the date of first documented complication, assessed up to 30 days.]
Secondary outcome measures (1)
- Long-term complications [Time frame: From 31th day from implantation until the date of first documented complication, assessed up to 6 months.]
Eligibility criteria
Inclusion criteria
- patients with indication for leadless pacemaker implantation according to current Guidelines on cardiac pacing.
Exclusion criteria
- inability to sign informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Azienda Ospedaliera "Card. G. Panico" — Tricase
Publications
- 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. PMID 36036679
Identifiers
NCT: NCT06656468 · OPUPI registry