Atrial FibrillationNCT01673256
DEtermining Accuracy and TrEnding CharacTerization of AF
An observational study of Atrial Fibrillation, run by Abbott Medical Devices at 13 sites in 2 countries.
Trial summary
The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- SJM Confirm ICM
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Sep 2012to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Primary Care Clinic
Who may be able to join
- The subject has been implanted with a SJM Confirm ICM, DM2102.
- The subject has or is suspected to have paroxysmal AF.
- The subject is ≥ 18 years of age.
- The subject is willing and able to provide written Informed Consent (prior to any investigational related procedure).
Who cannot join
- The subject has persistent (>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous AF >1 year) or permanent AF (not attempting to restore sinus rhythm).
- The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
- The subject has a contraindication to Holter recording.
- The subject has already received an active implantable medical device other than the SJM Confirm ICM, DM2102.
- The subject is unable to comply with the follow up schedule.
- The subject is participating in another investigational device or drug investigation.
- The subject is pregnant or is planning to become pregnant during the duration of the investigation.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Germany11 sites
Rhön-Klinikum, Herz- und Gefäß-Klinik
Bad Neustadt an der Saale
Herz -und Diabeteszentrum
Bad Oeynhausen, 32545
Charite, Campus Virchow-Klinikum
Berlin
Klinikum Coburg
Coburg
University of Dresden - Heart Center
Dresden
Klinikum Frankfurt Höchst GmbH
Frankfurt
Klinikum Ingolstadt GmbH
Ingolstadt, 85049
Herzzentrum Leipzig
Leipzig
Isar Heart Center
Munich, 80331
Hegau-Bodensee-Kliniken
Singen
Schwarzwald-Baar Klinikum GmbH
Villingen-Schwenningen
Netherlands2 sites
Albert Schweitzer Hospital
Dordrecht
Hagahospital
The Hague
About this study
The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).
- Conditions
- Atrial Fibrillation
- Being tested
- SJM Confirm ICM
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SJM Confirm ICMDevice
| Study group | Role | What they receive |
|---|---|---|
| SJM Confirm ICM Observational Group | Not described Receives: Device: SJM Confirm ICM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.
Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.
Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.
Measured: 4 days after Holter starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thorsten Lewalter, MD, Principal investigator, Isar Heart Center Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673256
- Sponsor's protocol ID
- DETECT AF
- Status last verified
- Feb 2019
- First submitted
- 22 Aug 2012
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEtermining Accuracy and TrEnding CharacTerization of AF
- ClinicalTrials.gov ID
- NCT01673256
- Acronym / sponsor ID
- DETECT AF
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Posted 18 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SJM Confirm ICM Observational Group | – | Device: SJM Confirm ICM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (4 listed)
- The subject has been implanted with a SJM Confirm ICM, DM2102.
- The subject has or is suspected to have paroxysmal AF.
- The subject is ≥ 18 years of age.
- The subject is willing and able to provide written Informed Consent (prior to any investigational related procedure).
Key exclusion criteria (7 listed)
- The subject has persistent (>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous AF >1 year) or permanent AF (not attempting to restore sinus rhythm).
- The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
- The subject has a contraindication to Holter recording.
- The subject has already received an active implantable medical device other than the SJM Confirm ICM, DM2102.
- The subject is unable to comply with the follow up schedule.
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 |
|---|---|---|
| SJM Confirm ICM | Device | SJM Confirm ICM Observational Group |
Primary outcome
Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.
Time frame: 4 days after Holter starts
Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM. Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thorsten Lewalter, MD principal investigator
Isar Heart Center Munich
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Abbott Medical Devices at 13 sites in 2 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 4 inclusion and 7 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Netherlands. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording. (time frame: 4 days after Holter starts). 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 Feb 2019.