Atrial FibrillationEcho-If-AFNCT05690529
Echocardiographic Markers of Atrial Fibrillation Recurrence Post Radiofrequency Ablation
An observational study of Atrial Fibrillation, run by Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
Trial summary
Determine echocardiographic predictors of atrial fibrillation recurrence post radiofrequency Ablation and evaluate markers of low voltage areas on 3D mapping. 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?
- Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 29 Mar 2022to 31 May 2024
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing radiofrequency AF ablation guided by 3D mapping
Who may be able to join
- paroxysmal or persistent ablation
Who cannot join
- previous AF ablation
- previous left atrial ablation
- refusal to give informed consent
- congenital cradiomiopathy
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar e Universitário de Coimbra
Coimbra
Diogo Fernandes, 239400400, 11750@chuc.min-saude.pt
About this study
Determine echocardiographic predictors of atrial fibrillation recurrence post radiofrequency Ablation and evaluate markers of low voltage areas on 3D mapping.
- Conditions
- Atrial Fibrillation
- Being tested
- Ablation
- Keywords
- Atrial fibrillation, Radiofrequency ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Radiofrequency AF ablatoon
| Study group | Role | What they receive |
|---|---|---|
| No recurrence | No recurrence of AF Receives: Procedure: Ablation | |
| Recurrence | Recurrence of AF Receives: Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Measured: 1 year
Secondary outcomes (1)
Low voltage areas
Measured: At procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start29 Mar 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diogo de Almeida Fernandes, Unidade Local de Saúde de Coimbra, EPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690529
- Sponsor's protocol ID
- Echo AF 2021
- Acronym
- Echo-If-AF
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Markers of Atrial Fibrillation Recurrence Post Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT05690529
- Acronym / sponsor ID
- Echo-If-AF / Echo AF 2021
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Radiofrequency ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPEUniversity, hospital or other
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 19 Jan 2023 (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.
Determine echocardiographic predictors of atrial fibrillation recurrence post radiofrequency Ablation and evaluate markers of low voltage areas on 3D mapping.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No recurrence | – | Procedure: AblationNo recurrence of AF |
| Recurrence | – | Procedure: AblationRecurrence of AF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing radiofrequency AF ablation guided by 3D mapping
Key inclusion criteria (1 listed)
- paroxysmal or persistent ablation
Key exclusion criteria (4 listed)
- previous AF ablation
- previous left atrial ablation
- refusal to give informed consent
- congenital cradiomiopathy
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 |
|---|---|---|
| AblationRadiofrequency AF ablatoon | Procedure or surgery | No recurrence, Recurrence |
Primary outcome
Recurrence
Time frame: 1 year
1 secondary outcome
Low voltage areas
Time frame: At procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Unidade Local de Saúde de Coimbra, EPE at 1 site in Portugal.
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 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 19 Jan 2023. 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 Portugal. 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 Diogo Fernandes (239400400, 11750@chuc.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 1 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 19 Jan 2023.