CardiomyopathiesOBSERVONCT02735811
OBSERVational Registry on Long-term Outcome of ICD Patients
An observational study of Cardiomyopathies, run by Azienda Ospedaliera Cardinale G. Panico at 6 sites in Italy.
Trial summary
Multicentric, observational, retrospective registry including patients underwent ICD implantation for any indication. The primary aim of the registry is to evaluate the long-term outcome of patients receiving an ICD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies
- What is being tested?
- Assesment of long-term outcome of ICD patients
- Type of treatment
- Medical device
- How many people
- 1,300 participants
- Where
- 6 sitesItaly
- Study dates
- Mar 2015to May 2016
- 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 implantation from January 2010 to December 2012 for any indication at enrolling hospitals
Who may be able to join
- ICD implantation fo any indication;
- 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, 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
Ospedale Maggiore della Carità
Novara, Novara
Gabriele Dell'Era, MD, gdell'era@gmail.com
- Recruiting
Ospedale San Filippo Neri
Roma, Roma, 00135
Stefano Aquilani, MD, +393479657114, saquilani@yahoo.it
- Recruiting
"Card. G. Panico" Hospital
Tricase, Lecce, 73039
Pietro Palmisano, MD, dr.palmisano@libero.it
About this study
Official title: The Italian Multicentric OBSERVational Registry on Long-term Outcome of ICD Patients (OBSERVO-ICD Registry)
Multicentric, observational, retrospective registry including patients underwent ICD implantation for any indication. The primary aim of the registry is to evaluate the long-term outcome of patients receiving an ICD.
Read the detailed description
Multicentric, observational, retrospective registry including patients underwent ICD implantation for any indication in the period from 2010 to 2012. The aims of the registry are to evaluate the occurrence of complications related to ICD implantation (including ICD shocks and electrical storm), and the mortality during a long-term follow-up.
- Conditions
- Cardiomyopathies
- Being tested
- Assesment of long-term outcome of ICD patients
- Keywords
- Implantable defibrillator, Cardiomyopathies
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assesment of long-term outcome of ICD patientsDevice
Also called Implantable Cardioverter Defibrillator
Evaluation during follow-up of the occurrence of complications related to ICD implantation 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 (1)
Complications related to ICD implantation
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 posted13 Apr 2016 (estimated)
- Study startMar 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (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 CardiomyopathiesStudies 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
- 1,300 participants (estimated)
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
- Investigators
- Pietro Palmisano, MD, Principal investigator, Cardiology Unit - "Card. G. Panico" Hospital - Tricase
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735811
- Sponsor's protocol ID
- OBSERVO
- Acronym
- OBSERVO
- Status last verified
- Apr 2016
- First submitted
- 2 Apr 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Guerra F, Palmisano P, Dell'Era G, Ziacchi M, Ammendola E, Bonelli P, Patani F, Cupido C, Devecchi C, Accogli M, Occhetta E, Santangelo L, Biffi M, Boriani G, Capucci A; Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Implantable cardioverter-defibrillator programming and electrical storm: Results of the OBSERVational registry On long-term outcome of ICD patients (OBSERVO-ICD). Heart Rhythm. 2016 Oct;13(10):1987-92. doi: 10.1016/j.hrthm.2016.06.007. Epub 2016 Jun 9.
PubMed 27291511
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Italian Multicentric OBSERVational Registry on Long-term Outcome of ICD Patients (OBSERVO-ICD Registry)
- ClinicalTrials.gov ID
- NCT02735811
- Acronym / sponsor ID
- OBSERVO / OBSERVO
- Conditions
- Cardiomyopathies
- Keywords
- Implantable defibrillator, Cardiomyopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Cardinale G. PanicoUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 13 Apr 2016 (estimated)
- 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 ICD implantation for any indication. The primary aim of the registry is to evaluate the long-term outcome of patients receiving an ICD.
Detailed description
Multicentric, observational, retrospective registry including patients underwent ICD implantation for any indication in the period from 2010 to 2012. The aims of the registry are to evaluate the occurrence of complications related to ICD implantation (including ICD shocks and electrical storm), 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 implantation from January 2010 to December 2012 for any indication at enrolling hospitals
Key inclusion criteria (2 listed)
- ICD implantation fo any indication;
- 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 long-term outcome of ICD patientsAlso: Implantable Cardioverter DefibrillatorEvaluation during follow-up of the occurrence of complications related to ICD implantation and of death | Device | – |
Primary outcome
Death for any cause
Time frame: an average of 2 years
1 secondary outcome
Complications related to ICD implantation
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 13 Apr 2016.
- Derived from this study: PubMed 27291511Guerra F, Palmisano P, Dell'Era G, Ziacchi M, Ammendola E, Bonelli P, Patani F, Cupido C, Devecchi C, Accogli M, Occhetta E, Santangelo L, Biffi M, Boriani G, Capucci A; Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Implantable cardioverter-defibrillator programming and electrical storm: Results of the OBSERVational registry On long-term outcome of ICD patients (OBSERVO-ICD). Heart Rhythm. 2016 Oct;13(10):1987-92. doi: 10.1016/j.hrthm.2016.06.007. Epub 2016 Jun 9.
- 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.
Pietro Palmisano, MD principal investigator
Cardiology Unit - "Card. G. Panico" Hospital - Tricase
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 Cardiomyopathies, 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 2 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 13 Apr 2016. 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?
On the ClinicalTrials.gov record for NCT02735811, 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 13 Apr 2016.