Cryptogenic StrokeNCT00861133
Cryptogenic Stroke Study
A study testing Sleuth AT Implantable ECG Monitoring System in people with Cryptogenic Stroke, run by Transoma Medical at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptogenic Stroke
- What is being tested?
- Sleuth AT Implantable ECG Monitoring System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to May 2011
- Phase
- Interventional
- 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
Who may be able to join
- Recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours.
- Negative brain image for hemorrhagic stroke
- In sinus rhythm at time of enrollment
Who cannot join
- Know history of atrial fibrillation
- Previous implanted cardiac device (ppM or ICD)
- Serious illness making it unlikely to survive one year
- Known secondary cause of stroke
Trial locations and contacts
1 site in 1 country.
M Broich contact
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
About this study
Official title: Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation After Cryptogenic Stroke
The purpose of this study is to determine whether the Sleuth Implantable Loop Recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.
- Conditions
- Cryptogenic Stroke
- Being tested
- Sleuth AT Implantable ECG Monitoring System
- Keywords
- cardiac monitor, loop recorder, stroke, ECG, Implantable Loop Recorder, cryptogenic, ILR
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleuth AT Implantable ECG Monitoring SystemDevice
The study device provides monitoring only. It cannot provide intervention or treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of atrial fibrillation at one year from Sleuth implantation.
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 posted13 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptogenic StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transoma Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew Krahn, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861133
- Sponsor's protocol ID
- CLP-008
- Status last verified
- May 2009
- First submitted
- 12 Mar 2009
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
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
- Long-Term Cardiac Monitoring for Detection of Atrial Fibrillation After Cryptogenic Stroke
- ClinicalTrials.gov ID
- NCT00861133
- Acronym / sponsor ID
- CLP-008
- Conditions
- Cryptogenic Stroke
- Keywords
- cardiac monitor, loop recorder, stroke, ECG, Implantable Loop Recorder, cryptogenic, ILR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Transoma MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Apr 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 13 Mar 2009 (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 determine whether the Sleuth Implantable Loop Recorder will enhance detection of latent atrial fibrillation in patients after cryptogenic stroke.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recent stroke (within 30 days) as defined by who has a sudden onset of focal neurological deficits presumed vascular etiology and lasting more than 24 hours.
- Negative brain image for hemorrhagic stroke
- In sinus rhythm at time of enrollment
Key exclusion criteria (4 listed)
- Know history of atrial fibrillation
- Previous implanted cardiac device (ppM or ICD)
- Serious illness making it unlikely to survive one year
- Known secondary cause of stroke
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 |
|---|---|---|
| Sleuth AT Implantable ECG Monitoring SystemThe study device provides monitoring only. It cannot provide intervention or treatment. | Device | – |
Primary outcome
Incidence of atrial fibrillation at one year from Sleuth implantation.
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.
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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.
M Broich contact
Andrew Krahn, MD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleuth AT Implantable ECG Monitoring System in people with Cryptogenic Stroke, run by Transoma Medical at 1 site 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 3 inclusion and 4 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 1 site 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?
Contact M Broich (mbroich@transomamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of atrial fibrillation at one year from Sleuth implantation. (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.