SyncopePhase 4NCT00170261
ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope
A Phase 4 study testing Use of an Implantable Loop Recorder in people with Syncope, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in Germany.
Trial summary
This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a primary implantation of a loop recorder versus the conventional diagnostic cascade for syncope most likely due to cardiac arrhythmia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Syncope
- What is being tested?
- Use of an Implantable Loop Recorder
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesGermany
- Study dates
- Apr 2002to Sep 2006
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Two or more episodes of syncope (most likely due to cardiac arrhythmia) of uncertain etiology within the last 12 months or more than one syncope and two presyncopes
Who cannot join
- Indication for the implantation of a pacemaker
- Indication for the implantation of an implantable cardioverter defibrillator
- Cardiac diseases which need intervention (KHK, aortic stenosis, mitral stenosis, left ventricular [LV] outflow stenosis, decompensated heart failure)
- Contraindication for a diagnostic procedure requested by the study protocol
- Enrollment in another study
- Circumstances or comorbidities which do not allow enrollment
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Vivantes Klinikum am Urban
Berlin, 10967
Humbold Klinikum
Berlin, 13509
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20251
About this study
Official title: Early Loop-Recorder in Suspected Arrhythmogenic Syncope
This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a primary implantation of a loop recorder versus the conventional diagnostic cascade for syncope most likely due to cardiac arrhythmia.
- Conditions
- Syncope
- Being tested
- Use of an Implantable Loop Recorder
- Keywords
- Syncope of uncertain etiology, Repeated presyncopes
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of an Implantable Loop RecorderDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of diagnostics per patient until final cardiac diagnosis has been made
Secondary outcomes (4)
Cost of diagnostics until final diagnosis has been made
Rate of correct cardiac diagnoses
Comparison of time needed to make a diagnosis
Comparison of pre-syncopes and syncopes occuring in both groups after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2002
- Primary completionSep 2005
- Study completionSep 2006
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.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Investigators
- H.-C- Ehlers, MD, Principal investigator, Vivantes Klinikum am Urban
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170261
- Sponsor's protocol ID
- CEN_G_CA_4
- Status last verified
- Apr 2018
- First submitted
- 12 Sep 2005
- Last updated
- 3 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Loop-Recorder in Suspected Arrhythmogenic Syncope
- ClinicalTrials.gov ID
- NCT00170261
- Acronym / sponsor ID
- CEN_G_CA_4
- Conditions
- Syncope
- Keywords
- Syncope of uncertain etiology, Repeated presyncopes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Apr 2002
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 15 Sep 2005 (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.
This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a primary implantation of a loop recorder versus the conventional diagnostic cascade for syncope most likely due to cardiac arrhythmia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Two or more episodes of syncope (most likely due to cardiac arrhythmia) of uncertain etiology within the last 12 months or more than one syncope and two presyncopes
Key exclusion criteria (6 listed)
- Indication for the implantation of a pacemaker
- Indication for the implantation of an implantable cardioverter defibrillator
- Cardiac diseases which need intervention (KHK, aortic stenosis, mitral stenosis, left ventricular [LV] outflow stenosis, decompensated heart failure)
- Contraindication for a diagnostic procedure requested by the study protocol
- Enrollment in another study
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 |
|---|---|---|
| Use of an Implantable Loop Recorder | Device | – |
Primary outcome
Cost of diagnostics per patient until final cardiac diagnosis has been made
4 secondary outcomes
Cost of diagnostics until final diagnosis has been made
Rate of correct cardiac diagnoses
Comparison of time needed to make a diagnosis
Comparison of pre-syncopes and syncopes occuring in both groups after enrollment
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 3 Jul 2025.
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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.
H.-C- Ehlers, MD principal investigator
Vivantes Klinikum am Urban
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Use of an Implantable Loop Recorder in people with Syncope, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in Germany.
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 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cost of diagnostics per patient until final cardiac diagnosis has been made. 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 3 Jul 2025.