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
- Are there results?
- None posted in the registry
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.
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Patients Undergoing Leadless Pacemaker Implantaton
- ClinicalTrials.gov ID
- NCT06656468
- Acronym / sponsor ID
- OPUPI / OPUPI registry
- Conditions
- Bradyarrhythmias
- Keywords
- Bradyarrhythmias, leadless pacemaker, complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Cardinale G. PanicoUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leadless pacemaker patients | – | Device: Pacemaker and defibrillatorConsecutive patients undergoing leadless pacemaker patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication for leadless pacemaker implantation for symptomatic bradyarrhythmias according to current Guidelines on cardiac pacing.
Key inclusion criteria (1 listed)
- patients with indication for leadless pacemaker implantation according to current Guidelines on cardiac pacing.
Key exclusion criteria (1 listed)
- inability to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker and defibrillatorLeadless pacemaker implantation procedure performed accordng to usual clinical practice. The indication for pacemaker implantation will be based on current guidelines. | Device | Leadless pacemaker patients |
Primary outcome
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
1 secondary outcome
Long-term complications
Time frame: From 31th day from implantation until the date of first documented complication, assessed up to 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Background: PubMed 36036679Palmisano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradyarrhythmias, run by Azienda Ospedaliera Cardinale G. Panico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute complications (time frame: From date of implantation until the date of first documented complication, assessed up to 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06656468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.