SyncopeOBSERV-ECGNCT00717106
Observational Study of the Sleuth Implantable ECG Monitoring System
An observational study of Syncope and Presyncope, run by Transoma Medical at 8 sites in United States.
Trial summary
The purpose of this study is to obtain information on real-world device performance clinical assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Syncope, Presyncope, Fainting
- How many people
- 250 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2008to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cardiology or primary care clinics
Who may be able to join
- Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac arrhythmia
Who cannot join
- Patients that have had a myocardial infarction (MI) < 30 days prior to implant
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
SUMMA-NEOCS Health Systems
Akron, Ohio, 44304
Piedmont Hospital
Atlanta, Georgia, 30309
Western Maryland Health Systems
Cumberland, Maryland, 21502
Center for Cardiac Arrhythmias
Houston, Texas, 77030
Cardiology Consultants of East Michigan
Lapeer, Michigan, 48446
Morgantown Internal Medicine Group
Morgantown, West Virginia, 26505
St. Luke's - Roosevelt
New York, New York, 10019
Main Line Health - Lankenau Hospital
Wynnewood, Pennsylvania, 19096
About this study
The purpose of this study is to obtain information on real-world device performance clinical assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring System.
- Conditions
- Syncope, Presyncope, Fainting, Cardiac Arrhythmia
- Keywords
- ILR, ECG monitoring, cardiac arrhythmia, syncope, presyncope, fainting
- Medical subject headings
- Syncope, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2008
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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transoma Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wim Stegink, Study director, Transoma Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717106
- Sponsor's protocol ID
- CLP-007
- Acronym
- OBSERV-ECG
- Status last verified
- May 2009
- First submitted
- 14 Jul 2008
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Sleuth Implantable ECG Monitoring System
- ClinicalTrials.gov ID
- NCT00717106
- Acronym / sponsor ID
- OBSERV-ECG / CLP-007
- Conditions
- Syncope, Presyncope, Fainting, Cardiac Arrhythmia
- Keywords
- ILR, ECG monitoring, cardiac arrhythmia, syncope, presyncope, fainting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Transoma MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- First posted
- 16 Jul 2008 (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 obtain information on real-world device performance clinical assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cardiology or primary care clinics
Key inclusion criteria (2 listed)
- Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac arrhythmia
Key exclusion criteria (1 listed)
- Patients that have had a myocardial infarction (MI) < 30 days prior to implant
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
Time to diagnosis
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2009.
Related trials for Syncope
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
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.
Wim Stegink study director
Transoma Medical
8 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 and Presyncope, run by Transoma Medical at 8 sites in United States.
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 5 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Time to diagnosis (time frame: one year). 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 5 May 2009.