SyncopeITHO04NCT02253134
Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)
An observational study of Syncope and Palpitations, run by LivaNova at 10 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of suspected arrhythmic origin, within 30 days before enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Palpitations
- How many people
- 395 participants
- Where
- 10 sitesin 5 countries
- Study dates
- Aug 2010to Jun 2013
- 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 that present unexplained Syncope and/or palpitations events of a suspected arrhythmic origin
Who may be able to join
- Syncope and/or palpitations events occurred in the last 30 days
- Events likely of arrhythmic origin
- No conclusive diagnosis established yet
- High probability of episodes recurrence (presence of at least one previous event in the last 12 months)
- Patient has signed the consent to participate to the study and/or to data treatment
Who cannot join
- Inability to understand the purpose of the study or refusal to cooperate
- Expected low compliance with the recording technique.
- Logistical impossibility to deliver the ELR within 30 days after the index event (or after discharge from ER and/or hospitalization and/or clinic visit)
- Already included in other competitor clinical study
- Under guardianship
- Age less than 18
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Spain5 sites
Institut Universitari Dexeus
Barcelona, 08028
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital de Basurto
Bilbao, 48013
Hospital Universitario 12 de Octubre
Madrid, 28041
Italy2 sites
Az. Sanit. Locale N. 4 Chiavarese
Lavagna, 16033
Ospedale Niguarda Ca Granda
Milan, 20162
Switzerland1 site
Universitätsklinik für Kardiologie Inselspital
Bern, 3010
About this study
The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of suspected arrhythmic origin, within 30 days before enrollment.
Read the detailed description
Diagnostic yield (primary outcome) definition = Number of patients with conclusive diagnosis (as per investigators' decision) over the total number of patients
- Conditions
- Syncope, Palpitations
- Keywords
- Syncopal events, Palpitation events
- Medical subject headings
- Syncope
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the mean value of the diagnostic yield in one month
number of pts with a conclusive diagnosis (per investigators' decision) over the total number of patients
Measured: 1 month
Secondary outcomes (3)
Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment
Measured: 1 month
Recurrence rate stratified by syncope /palpitation, by week and by type of events occurred post enrollment
Measured: 1 month
Analysis of arrhythmic vs non arrhythmic findings stratified by kind of index events (syncope /palpitations)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startAug 2010
- Primary completionJun 2013
- Study completionJun 2013
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
- Time perspective
- Prospective
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emanuela T Locati, Principal investigator, Azienda Ospedaliera Niguarda Ca' Granda - Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253134
- Sponsor's protocol ID
- SYNARR-FLASH STUDY - ITHO04
- Acronym
- ITHO04
- Status last verified
- Sep 2014
- First submitted
- 10 Jul 2013
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)
- ClinicalTrials.gov ID
- NCT02253134
- Acronym / sponsor ID
- ITHO04 / SYNARR-FLASH STUDY - ITHO04
- Conditions
- Syncope, Palpitations
- Keywords
- Syncopal events, Palpitation events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Oct 2014 (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.
The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of suspected arrhythmic origin, within 30 days before enrollment.
Detailed description
Diagnostic yield (primary outcome) definition = Number of patients with conclusive diagnosis (as per investigators' decision) over the total number of patients
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that present unexplained Syncope and/or palpitations events of a suspected arrhythmic origin
Key inclusion criteria (5 listed)
- Syncope and/or palpitations events occurred in the last 30 days
- Events likely of arrhythmic origin
- No conclusive diagnosis established yet
- High probability of episodes recurrence (presence of at least one previous event in the last 12 months)
- Patient has signed the consent to participate to the study and/or to data treatment
Key exclusion criteria (6 listed)
- Inability to understand the purpose of the study or refusal to cooperate
- Expected low compliance with the recording technique.
- Logistical impossibility to deliver the ELR within 30 days after the index event (or after discharge from ER and/or hospitalization and/or clinic visit)
- Already included in other competitor clinical study
- Under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the mean value of the diagnostic yield in one month
Time frame: 1 month
number of pts with a conclusive diagnosis (per investigators' decision) over the total number of patients
3 secondary outcomes
Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment
Time frame: 1 month
Recurrence rate stratified by syncope /palpitation, by week and by type of events occurred post enrollment
Time frame: 1 month
Analysis of arrhythmic vs non arrhythmic findings stratified by kind of index events (syncope /palpitations)
Time frame: 1 month
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 1 Oct 2014.
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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.
Emanuela T Locati principal investigator
Azienda Ospedaliera Niguarda Ca' Granda - Milano
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Palpitations, run by LivaNova at 10 sites in 5 countries.
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 5 inclusion and 6 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 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, Italy, Belgium, Portugal, Switzerland. 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?
Evaluate the mean value of the diagnostic yield in one month (time frame: 1 month). 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 1 Oct 2014.