Atrial FibrillationAF-PROMSNCT06731543
Development of an AF Specific Quality of Life Questionnaire: AF-PROMS
An observational study of Atrial Fibrillation, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
This study is aiming to develop a Health Related Quality of Life (HRQoL) scale for patients who have atrial fibrillation (AF). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 206 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2014to 18 Oct 2024
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with atrial fibrillation (AF)
Who may be able to join
- Patients with atrial fibrillation (AF)
Who cannot join
- Exclude any participants who it is felt participation will cause distress.
- Exclude participants who do not give consent to take part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Condition Specific Quality of Life Scale for Atrial Fibrillation: AF-PROMS
This study is aiming to develop a Health Related Quality of Life (HRQoL) scale for patients who have atrial fibrillation (AF).
Read the detailed description
This study is aiming to develop and validate a Health Related Quality of Life (HRQoL) scale for patients who have atrial fibrillation (AF). As this questionnaire is currently under development, it is anticipated this measure will be a short questionnaire which will measure various aspects of quality of life. Once the questionnaire has been validated further details of the final metric used and aspects of quality of life covered in the questionnaire can be provided.
- Conditions
- Atrial Fibrillation
- Being tested
- No interventions will be made
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions will be madeOther
| Study group | Role | What they receive |
|---|---|---|
| Patients who have atrial fibrillation | Not described Receives: Other: No interventions will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
No primary outcomes will be measured
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start14 Feb 2014
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- City, University of London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731543
- Sponsor's protocol ID
- Version 5. 14/July/2014
- Acronym
- AF-PROMS
- Status last verified
- May 2026
- First submitted
- 14 Sep 2015
- Last updated
- 8 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Condition Specific Quality of Life Scale for Atrial Fibrillation: AF-PROMS
- ClinicalTrials.gov ID
- NCT06731543
- Acronym / sponsor ID
- AF-PROMS / Version 5. 14/July/2014
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- City, University of London
- Study start
- 14 Feb 2014 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 12 Dec 2024 (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.
This study is aiming to develop a Health Related Quality of Life (HRQoL) scale for patients who have atrial fibrillation (AF).
Detailed description
This study is aiming to develop and validate a Health Related Quality of Life (HRQoL) scale for patients who have atrial fibrillation (AF). As this questionnaire is currently under development, it is anticipated this measure will be a short questionnaire which will measure various aspects of quality of life. Once the questionnaire has been validated further details of the final metric used and aspects of quality of life covered in the questionnaire can be provided.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have atrial fibrillation | – | Other: No interventions will be made |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with atrial fibrillation (AF)
Key inclusion criteria (1 listed)
- Patients with atrial fibrillation (AF)
Key exclusion criteria (2 listed)
- Exclude any participants who it is felt participation will cause distress.
- Exclude participants who do not give consent to take part in the study
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 |
|---|---|---|
| No interventions will be made | Other | Patients who have atrial fibrillation |
Primary outcome
No primary outcomes will be measured
Time frame: 5 years
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 8 May 2026.
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Atrial Fibrillation (AF)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 1 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: finished, as of the sponsor's last update on 8 May 2026. 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 Kingdom. 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?
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?
No primary outcomes will be measured (time frame: 5 years). 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 8 May 2026.