SyncopeSYNCOPACEDNCT04229589
Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope
An observational study of Syncope, run by Azienda Ospedaliera Cardinale G. Panico at 7 sites in Italy.
Trial summary
Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope
- What is being tested?
- Clinic follow-up
- How many people
- 1,364 participants
- Where
- 7 sitesItaly
- Study dates
- 1 Jan 2010to 1 May 2020
- How long will I take part?
- 7 Years
- 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
- Adult, Older adult
Study population: Consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope (proven or presumed) according current guidelines
Who may be able to join
- patients undergoing pacemaker implantation for bradyarrhythmic syncope
Who cannot join
- age <18 years
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Federico Guerra
Ancona
Policlinico S.Orsola-Malpighi
Bologna, 40138
AO Pugliese-Ciaccio
Catanzaro, 88100
Monaldi Hospital
Naples
AOU "Maggiore della Carità"
Novara, 28100
Dell'Era Gabriele
Novara
"Card. G. Panico" Hospital
Tricase, Lecce, 73039
About this study
Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.
Read the detailed description
Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope. All consecutive patients aged ≥18 years who underwent pacemaker implantation for syncope of bradyarrhythmic aetiology (proven or presumed) at participating centers from January 2010 to December 2013 were enrolled in the registry. During follow-up the occurrence of the first syncopal relapse after pacemaker implantation is recorded.
- Conditions
- Syncope
- Being tested
- Clinic follow-up
- Keywords
- Syncope, pacemaker, bradyarrhythmias
- Medical subject headings
- Syncope, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic follow-upOther
Patients are regularly evaluated to asses the occurrence of syncopal relapses
| Study group | Role | What they receive |
|---|---|---|
| Study population | Consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope Receives: Other: Clinic follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Syncopal relapse
First syncopal relapse after pacemaker implantation
Measured: march 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jan 2010
- Primary completion1 Mar 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies 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
- 1,364 participants (actual)
- Target duration
- 7 Years
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
- NCT04229589
- Sponsor's protocol ID
- SYNCOPACED
- Acronym
- SYNCOPACED
- Status last verified
- Dec 2019
- First submitted
- 12 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope
- ClinicalTrials.gov ID
- NCT04229589
- Acronym / sponsor ID
- SYNCOPACED / SYNCOPACED
- Conditions
- Syncope
- Keywords
- Syncope, pacemaker, bradyarrhythmias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,364 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Cardinale G. PanicoUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 18 Jan 2020 (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.
Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.
Detailed description
Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope. All consecutive patients aged ≥18 years who underwent pacemaker implantation for syncope of bradyarrhythmic aetiology (proven or presumed) at participating centers from January 2010 to December 2013 were enrolled in the registry. During follow-up the occurrence of the first syncopal relapse after pacemaker implantation is recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Other: Clinic follow-upConsecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope (proven or presumed) according current guidelines
Key inclusion criteria (1 listed)
- patients undergoing pacemaker implantation for bradyarrhythmic syncope
Key exclusion criteria (1 listed)
- age <18 years
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 |
|---|---|---|
| Clinic follow-upPatients are regularly evaluated to asses the occurrence of syncopal relapses | Other | Study population |
Primary outcome
Syncopal relapse
Time frame: march 2020
First syncopal relapse after pacemaker implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope, run by Azienda Ospedaliera Cardinale G. Panico at 7 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
Syncopal relapse (time frame: march 2020). 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 18 Jan 2020.