Fibrillation, AtrialNCT04761315
Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (From the DAF-ESUS Registry)
An observational study of Fibrillation, Atrial, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz.
Trial summary
The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Fibrillation, Atrial
- How many people
- 380 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2016
- How long will I take part?
- 2 Years
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in sinus rhythm, with or without previous paroxysmal AF and with dual-chamber pacemakers (PMs), implantable cardioverterdefibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT) capable of atrial activity monitoring were included in the study
Who may be able to join
- Patients in sinus rhythm
- with or without previous paroxysmal AF
- with dual-chamber pacemakers (PMs), implantable cardioverterdefibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT)
- capable of atrial activity monitoring were included in the study
Who cannot join
- -Previous documented atrial fibrillation
About this study
The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.
Read the detailed description
The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.
- Conditions
- Fibrillation, Atrial
- Keywords
- cardiac implantable electronic devices, interatrial block, P-wave duration
- Medical subject headings
- Atrial Fibrillation, Interatrial Block
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial high rate new episodes
New episodes of atrial high rate episodes
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jan 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrillation, AtrialStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761315
- Sponsor's protocol ID
- TFM 2016-18
- Status last verified
- Feb 2021
- First submitted
- 11 Nov 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (From the DAF-ESUS Registry)
- ClinicalTrials.gov ID
- NCT04761315
- Acronym / sponsor ID
- TFM 2016-18
- Conditions
- Fibrillation, Atrial
- Keywords
- cardiac implantable electronic devices, interatrial block, P-wave duration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 18 Feb 2021 (actual)
- 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 presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.
Detailed description
The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in sinus rhythm, with or without previous paroxysmal AF and with dual-chamber pacemakers (PMs), implantable cardioverterdefibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT) capable of atrial activity monitoring were included in the study
Key inclusion criteria (4 listed)
- Patients in sinus rhythm
- with or without previous paroxysmal AF
- with dual-chamber pacemakers (PMs), implantable cardioverterdefibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT)
- capable of atrial activity monitoring were included in the study
Key exclusion criteria (1 listed)
- -Previous documented atrial fibrillation
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
Atrial high rate new episodes
Time frame: 24 months
New episodes of atrial high rate episodes
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 18 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrillation, Atrial, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz.
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 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: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Atrial high rate new episodes (time frame: 24 months). 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 18 Feb 2021.