BradyarrhythmiasOPUPINCT06656468
Outcome of Patients Undergoing Leadless Pacemaker Implantaton
An observational study of Bradyarrhythmias, run by Azienda Ospedaliera Cardinale G. Panico at 1 site in Italy.
Trial summary
Observational study aimed to evaluate the rate and of complications related to lealdless pacemaker implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradyarrhythmias
- What is being tested?
- Pacemaker and defibrillator
- Type of treatment
- Medical device
- How many people
- 900 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 1 Jun 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indication for leadless pacemaker implantation for symptomatic bradyarrhythmias according to current Guidelines on cardiac pacing.
Who may be able to join
- patients with indication for leadless pacemaker implantation according to current Guidelines on cardiac pacing.
Who cannot join
- inability to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Observational study aimed to evaluate the rate and of complications related to lealdless pacemaker implantation.
Read the detailed description
Observational, multicenter study enrolling consecutive patients undergoing leadless pacemaker implantation. Procedure details, intraprocedural complications, and n-hospital outcomes will be recorded.
- Conditions
- Bradyarrhythmias
- Being tested
- Pacemaker and defibrillator
- Keywords
- Bradyarrhythmias, leadless pacemaker, complications
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker and defibrillatorDevice
Leadless pacemaker implantation procedure performed accordng to usual clinical practice. The indication for pacemaker implantation will be based on current guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Leadless pacemaker patients | Consecutive patients undergoing leadless pacemaker patients Receives: Device: Pacemaker and defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute complications
Acute complications related to leadless pacemaker implantation
Measured: From date of implantation until the date of first documented complication, assessed up to 30 days.
Secondary outcomes (1)
Long-term complications
Complications related to leadless pacemaker implantation observed during long-term follow-up
Measured: From 31th day from implantation until the date of first documented complication, assessed up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Sep 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradyarrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Cardinale G. Panico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Palmisano, Azienda Ospedaliera Cardinale G. Panico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656468
- Sponsor's protocol ID
- OPUPI registry
- Acronym
- OPUPI
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36036679