Defibrillators, ImplantableIMPLANTEDNCT03061747
Multi-centre Observational Registry on Patients With Implantable Devices Remotely Monitored
An observational study of Defibrillators, Implantable and Heart Failure With Reduced Ejection Fraction, run by Azienda Ospedaliera Cardinale G. Panico at 6 sites in Italy.
Trial summary
Multicentric, observational, retrospective registry including patients underwent implantable device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016, followed by remote monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Defibrillators, Implantable, Heart Failure With Reduced Ejection Fraction, Arrythmia
- What is being tested?
- Assesment of outcome of implantable device patients
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 6 sitesItaly
- Study dates
- 1 Jun 2016to 30 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients underwent ICD or pacemaker implantation from January 2009 to September 2016 for any indication and followed by remote monitoring at enrolling hospitals
Who may be able to join
- ICD of pacemaker implantation fo any indication
- Followed by remote monitoring
- Age >18 years
Who cannot join
- life expectancy of less than one year
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites, 6 recruiting
- Recruiting
University Hospital "Umberto I - Lancisi - Salesi"
Ancona
Federico Guerra, MD, guerra.fede@gmail.com
- Recruiting
Policlinico S.Orsola-Malpighi
Bologna, Bologna, 40138
Matteo Ziacchi, MD, +393476785656, matteo.ziacchi@gmail.com
- Recruiting
AO Pugliese-Ciaccio
Catanzaro, Catanzaro, 88100
Vittorio Aspromonte, MD, +393472536524, dott.vittorioaspromonte@gmail.com
- Recruiting
Vito Fazzi Hospital
Lecce
Ennio C Pisanò, MD, enniopisano@hotmail.com
- Recruiting
Monaldi Hospital
Naples
Ernesto Ammendola, MD, ammendolaernesto@libero.it
- Recruiting
Dell'Era Gabriele
Novara, Novara
Gabriele Dell'Era, MD, gdell'era@gmail.com
About this study
Official title: Italian Multi-centre Observational Registry on Patients With impLANTable Devices Remotely monitorED
Multicentric, observational, retrospective registry including patients underwent implantable device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016, followed by remote monitoring. The aims of the registry are to evaluate the occurrence of atrial arrhythmias, of hospitalizations, and the mortality during a long-term follow-up.
- Conditions
- Defibrillators, Implantable, Heart Failure With Reduced Ejection Fraction, Arrythmia, Pacemaker
- Being tested
- Assesment of outcome of implantable device patients
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assesment of outcome of implantable device patientsDevice
Evaluation during follow-up of the occurrence of atrial arrhythmias, hospitalizations, and of death.
What is being measured
The primary outcome is the main question the study is designed to answer.
Death for any cause
Measured: an average of 2 years
Secondary outcomes (2)
Atrial arrhythmias
Measured: an average of 2 years
Hospitalizations for any cause
Measured: an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Jun 2016
- Primary completion15 Apr 2017 (estimated)
- Study completion30 Apr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Defibrillators, ImplantableStudies 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Cardinale G. Panico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pietro Palmisano, MD, Principal investigator, Card. G. Panico Hospital - Tricase - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061747
- Sponsor's protocol ID
- IMPLANTED
- Acronym
- IMPLANTED
- Status last verified
- Feb 2017
- First submitted
- 18 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Multi-centre Observational Registry on Patients With impLANTable Devices Remotely monitorED
- ClinicalTrials.gov ID
- NCT03061747
- Acronym / sponsor ID
- IMPLANTED / IMPLANTED
- Conditions
- Defibrillators, Implantable, Heart Failure With Reduced Ejection Fraction, Arrythmia, Pacemaker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Cardinale G. PanicoUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 15 Apr 2017 (estimated)
- Study completion
- 30 Apr 2017 (estimated)
- First posted
- 23 Feb 2017 (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.
Multicentric, observational, retrospective registry including patients underwent implantable device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016, followed by remote monitoring. The aims of the registry are to evaluate the occurrence of atrial arrhythmias, of hospitalizations, and the mortality during a long-term follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients underwent ICD or pacemaker implantation from January 2009 to September 2016 for any indication and followed by remote monitoring at enrolling hospitals
Key inclusion criteria (3 listed)
- ICD of pacemaker implantation fo any indication
- Followed by remote monitoring
- Age >18 years
Key exclusion criteria (1 listed)
- life expectancy of less than one year
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 |
|---|---|---|
| Assesment of outcome of implantable device patientsEvaluation during follow-up of the occurrence of atrial arrhythmias, hospitalizations, and of death. | Device | – |
Primary outcome
Death for any cause
Time frame: an average of 2 years
2 secondary outcomes
Atrial arrhythmias
Time frame: an average of 2 years
Hospitalizations for any cause
Time frame: an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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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.
Pietro Palmisano, MD principal investigator
Card. G. Panico Hospital - Tricase - Italy
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 Defibrillators, Implantable and Heart Failure With Reduced Ejection Fraction, 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 3 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 23 Feb 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pietro Palmisano, MD (+390833542430, dr.palmisano@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death for any cause (time frame: an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2017.