Outcome of Patients Undergoing Leadless Pacemaker Implantaton
OPUPI
1 other identifier
observational
900
1 country
1
Brief Summary
Observational study aimed to evaluate the rate and of complications related to lealdless pacemaker implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 21, 2024
CompletedFirst Posted
Study publicly available on registry
October 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedOctober 24, 2024
October 1, 2024
6.3 years
October 21, 2024
October 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute complications
Acute complications related to leadless pacemaker implantation
From date of implantation until the date of first documented complication, assessed up to 30 days.
Secondary Outcomes (1)
Long-term complications
From 31th day from implantation until the date of first documented complication, assessed up to 6 months.
Study Arms (1)
Leadless pacemaker patients
Consecutive patients undergoing leadless pacemaker patients
Interventions
Leadless pacemaker implantation procedure performed accordng to usual clinical practice. The indication for pacemaker implantation will be based on current guidelines.
Eligibility Criteria
Patients with indication for leadless pacemaker implantation for symptomatic bradyarrhythmias according to current Guidelines on cardiac pacing.
You may qualify if:
- patients with indication for leadless pacemaker implantation according to current Guidelines on cardiac pacing.
You may not qualify if:
- inability to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedaliera "Card. G. Panico"
Tricase, 73039, Italy
Related Publications (1)
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: 36036679BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 21, 2024
First Posted
October 24, 2024
Study Start
September 1, 2019
Primary Completion
December 31, 2025
Study Completion (Estimated)
June 1, 2026
Last Updated
October 24, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share