ArrhythmiaPULSENCT00719277
Feasibility Study: Sleuth Monitoring System
A study testing Sleuth Implantable ECG Monitoring System in people with Arrhythmia and Syncope, run by Transoma Medical at 1 site in Panama.
Trial summary
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Syncope
- What is being tested?
- Sleuth Implantable ECG Monitoring System
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 sitePanama
- Study dates
- Dec 2006to Sep 2009
- 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
- Age > = 18 years at time of enrollment
- Either of the following:
- MI > 30 days prior to enrolment and LVEF < = 35% by echocardiography (or nuclear imaging as necessary)
- Syncope of unknown etiology
Who cannot join
- Life expectancy < 12 months following enrollment
- Active infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.
- Conditions
- Arrhythmia, Syncope
- Being tested
- Sleuth Implantable ECG Monitoring System
- Keywords
- cardiac arrhythmia, syncope, ECG, implantable ECG monitor, ILR
- Medical subject headings
- Arrhythmias, Cardiac, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleuth 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.
Diagnostically viable ECG signals
Measured: daily
Secondary outcomes (1)
rate of device-related adverse events
Measured: 1, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startDec 2006
- Primary completionJul 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies 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
- 40 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
- NCT00719277
- Sponsor's protocol ID
- CLP-005
- Acronym
- PULSE
- Status last verified
- May 2009
- First submitted
- 17 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
- Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System
- ClinicalTrials.gov ID
- NCT00719277
- Acronym / sponsor ID
- PULSE / CLP-005
- Conditions
- Arrhythmia, Syncope
- Keywords
- cardiac arrhythmia, syncope, ECG, implantable ECG monitor, ILR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Transoma MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 21 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 the study is to evaluate the safety and performance of the Sleuth Monitoring system.
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 (4 listed)
- Age > = 18 years at time of enrollment
- Either of the following:
Key exclusion criteria (2 listed)
- Life expectancy < 12 months following enrollment
- Active infection
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 Implantable ECG Monitoring SystemThe study device provides monitoring only. It cannot provide intervention or treatment. | Device | – |
Primary outcome
Diagnostically viable ECG signals
Time frame: daily
1 secondary outcome
rate of device-related adverse events
Time frame: 1, 6, and 12 months
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.
Wim Stegink study director
Transoma Medical
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 Implantable ECG Monitoring System in people with Arrhythmia and Syncope, run by Transoma Medical at 1 site in Panama.
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 4 inclusion and 2 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 Panama. 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?
Diagnostically viable ECG signals (time frame: daily). 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.