Cardiac Implantable Electronic Device ComplicationsPOINTEDNCT03612635
Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications
An observational study of Cardiac Implantable Electronic Device Complications, run by Azienda Ospedaliera Cardinale G. Panico at 6 sites in Italy.
Trial summary
The purpose of this registry is to evaluate the impact on patient outcome and on healthcare utilization of cardiac implantation electronic device complications during a long-term follow-up. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Implantable Electronic Device Complications
- What is being tested?
- Implantation of a cardiac implantable electronic device
- Type of treatment
- Medical device
- How many people
- 2,811 participants
- Where
- 6 sitesItaly
- Study dates
- 1 Jan 2010to 1 Feb 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with indication to receive a cardiac implantable electronic device (pacemaker or defibrillator).
Who may be able to join
- patients underwent cardiac implantable electronic device implantation according to current guidelines during the enrollment period.
Who cannot join
- patients already carriers of a cardiac implantable electronic device underwent replacement or upgrading of device.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Federico Guerra
Ancona
Policlinico S.Orsola-Malpighi
Bologna, 40138
Mattia Laffi
Genova
Monaldi Hospital
Naples
AOU "Maggiore della Carità"
Novara, 28100
"Card. G. Panico" Hospital
Tricase, Lecce, 73039
About this study
Official title: Impact on Patient Outcome and Healthcare Utilization of Cardiac ImplaNTable Electronic Devices Complications
The purpose of this registry is to evaluate the impact on patient outcome and on healthcare utilization of cardiac implantation electronic device complications during a long-term follow-up.
Read the detailed description
Multicentric, observational, prospective registry enrolling consecutive patients underwent pacemaker or defibrillator implantation, aimed to evaluate the impact of cardiac implantable device complications requiring surgical revision on healthcare utilization (number and length of hospitalizations), and on patient outcome (all-cause mortality and cardiac mortality), during a long-term follow-up.
- Being tested
- Implantation of a cardiac implantable electronic device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a cardiac implantable electronic deviceDevice
All patients enrolled in the registry underwent cardiac implantable electronic device implantation
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Death (dead/alive status assessment during follow-up)
Evaluation of all-cause mortality during follow-up
Measured: An average of 48 months
Secondary outcomes (1)
Occurrence of hospitalizations related to cardiac implantable electronic device complications
Evaluation of hospitalizations related to cardiac implantable electronic device complications
Measured: An average of 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Jan 2010
- Primary completion31 Dec 2012
- Study completion1 Feb 2017
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 Cardiac Implantable Electronic Device ComplicationsStudies 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
- 2,811 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Cardinale G. Panico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612635
- Sponsor's protocol ID
- POINTED
- Acronym
- POINTED
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Palmisano P, Sergi C, Panico V, Chiarillo MV, Chiuri MD, Martella ML, Stefanelli G, Martella D, Mauro R, Ponzetta MA, Parlavecchio A, Accogli M, Coluccia G. Impact on nurse workload and patient satisfaction of atrioventricular junction ablation performed simultaneously with conduction system pacing using a superior approach from the pocket compared with the conventional femoral approach. Eur J Cardiovasc Nurs. 2024 Oct 21;23(7):746-755. doi: 10.1093/eurjcn/zvae043.
PubMed 38552177
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Patient Outcome and Healthcare Utilization of Cardiac ImplaNTable Electronic Devices Complications
- ClinicalTrials.gov ID
- NCT03612635
- Acronym / sponsor ID
- POINTED / POINTED
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,811 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Cardinale G. PanicoUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 2 Aug 2018 (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.
The purpose of this registry is to evaluate the impact on patient outcome and on healthcare utilization of cardiac implantation electronic device complications during a long-term follow-up.
Detailed description
Multicentric, observational, prospective registry enrolling consecutive patients underwent pacemaker or defibrillator implantation, aimed to evaluate the impact of cardiac implantable device complications requiring surgical revision on healthcare utilization (number and length of hospitalizations), and on patient outcome (all-cause mortality and cardiac mortality), during a long-term follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with indication to receive a cardiac implantable electronic device (pacemaker or defibrillator).
Key inclusion criteria (1 listed)
- patients underwent cardiac implantable electronic device implantation according to current guidelines during the enrollment period.
Key exclusion criteria (1 listed)
- patients already carriers of a cardiac implantable electronic device underwent replacement or upgrading of device.
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 |
|---|---|---|
| Implantation of a cardiac implantable electronic deviceAll patients enrolled in the registry underwent cardiac implantable electronic device implantation | Device | – |
Primary outcome
All-cause Death (dead/alive status assessment during follow-up)
Time frame: An average of 48 months
Evaluation of all-cause mortality during follow-up
1 secondary outcome
Occurrence of hospitalizations related to cardiac implantable electronic device complications
Time frame: An average of 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 38552177Palmisano P, Sergi C, Panico V, Chiarillo MV, Chiuri MD, Martella ML, Stefanelli G, Martella D, Mauro R, Ponzetta MA, Parlavecchio A, Accogli M, Coluccia G. Impact on nurse workload and patient satisfaction of atrioventricular junction ablation performed simultaneously with conduction system pacing using a superior approach from the pocket compared with the conventional femoral approach. Eur J Cardiovasc Nurs. 2024 Oct 21;23(7):746-755. doi: 10.1093/eurjcn/zvae043.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Implantable Electronic Device Complications, run by Azienda Ospedaliera Cardinale G. Panico at 6 sites 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: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All-cause Death (dead/alive status assessment during follow-up) (time frame: An average of 48 months). 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 NCT03612635, 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 2 Aug 2018.