Atrial FibrillationNCT05559073
Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation Patients.
An observational study of Atrial Fibrillation and Radiofrequency Ablation, run by Assiut University.
Trial summary
Atrial fibrillation (AF) is the most common arrhythmia among adults with increasing risk of stroke, heart failure and mortality. The EAST-AFNET 4 trial showed that rhythm control treatment (Antiarrhythmic drugs AAD or catheter ablation) was associated with a lower risk of adverse cardiovascular outcomes than usual… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Radiofrequency Ablation
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2022to 30 Oct 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We enroll all symptomatic AF patients who referred to first (de- novo) RF ablation within (early) vs. after (late) one year from the first AF diagnosis.
Who may be able to join
- Paroxysmal and persistent atrial fibrillation (AF) documented on a 12 lead ECG, trans-telephonic monitoring (TTM) or Holter monitor (episodes of AF must be >30 seconds in duration to qualify as an inclusion criterion)
- Age of 18 years or older on the date of consent.
- Candidate for ablation based on AF that is symptomatic
- Informed Consent
Who cannot join
- Permenant AF
- Previous left atrial (LA) ablation or LA surgery
- AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
- Active intracardiac thrombus
- Pre-existing pulmonary vein stenosis or pulmonary vein stent
- Contraindication to anticoagulation or radiocontrast materials
Show all 16Show fewer
- Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography
- Cardiac valve prosthesis
- Severe mitral valve regurgitation or stenosis
- Myocardial infarction, percutaneous intervention, or coronary artery stenting during the 3-month period preceding the consent date
- Cardiac surgery during the three-month interval preceding the consent date
- Significant unrepaird congenital heart defect (including patent foramen ovale)
- NYHA class IV congestive heart failure
- Significant chronic kidney disease (eGFR <30 mL/min/1.73m2)
- Cerebral ischemic event (stroke or transient ischemic attack) during the six-month interval preceding the consent date
- Pregnancy and Life expectancy less than one year
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation
Atrial fibrillation (AF) is the most common arrhythmia among adults with increasing risk of stroke, heart failure and mortality.
The EAST-AFNET 4 trial showed that rhythm control treatment (Antiarrhythmic drugs AAD or catheter ablation) was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients who had recently (within one year) been diagnosed with atrial fibrillation.
Read more
In phase II/III GLORIA AF registry, Early AF ablation within 3 months from initial diagnosis in a contemporary cohort of patients who were predominantly treated with non-vitamin K antagonist oral anticoagulants was associated with a survival advantage compared to medical therapy alone.
Moreover, early AF ablation appeared to provide the greatest benefit compared to other treatments.
The ATTEST trial was a multicenter, randomized, prospective study in patients with paroxysmal atrial fibrillation (AF) designed to assess whether radiofrequency (RF) ablation is more effective in delaying the progression to persistent AF than AADs.
Patients >_65 years were significantly more likely to progress to persistent AF/AT than patients were <65 years, suggesting that early RF ablation may be an effective treatment strategy for delaying AF progression.
So, we hypothesize that early AF ablation within one year after first AF diagnosis may associate with improved procedures outcomes in symptomatic AF patients.
- Conditions
- Atrial Fibrillation, Radiofrequency Ablation
- Being tested
- Radiofrequency ablation
- Keywords
- Early referral, catheter ablation, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
pulmonary vein isolation using radiofrequency ablation.
| Study group | Role | What they receive |
|---|---|---|
| Early referral to ablation within one year after first documented AF diagnosis | Not described Receives: Procedure: Radiofrequency ablation | |
| Delayed referral to ablation after one year after first documented AF diagnosis | Not described Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from any atrial arrhythmia after single ablation procedure.
freedom from any documented atrial arrhythmia lasted for more than 30 seconds.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start6 Oct 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Retrospective
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Abdelrady Abdelsalam Farghaly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559073
- Sponsor's protocol ID
- Early Referral to AF Ablation
- Status last verified
- Sep 2022
- First submitted
- 24 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kuck KH, Lebedev DS, Mikhaylov EN, Romanov A, Geller L, Kalejs O, Neumann T, Davtyan K, On YK, Popov S, Bongiorni MG, Schluter M, Willems S, Ouyang F. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace. 2021 Mar 8;23(3):362-369. doi: 10.1093/europace/euaa298.
PubMed 33330909
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05559073
- Acronym / sponsor ID
- Early Referral to AF Ablation
- Conditions
- Atrial Fibrillation, Radiofrequency Ablation
- Keywords
- Early referral, catheter ablation, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 6 Oct 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 29 Sep 2022 (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.
Atrial fibrillation (AF) is the most common arrhythmia among adults with increasing risk of stroke, heart failure and mortality.
The EAST-AFNET 4 trial showed that rhythm control treatment (Antiarrhythmic drugs AAD or catheter ablation) was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients who had recently (within one year) been diagnosed with atrial fibrillation.
In phase II/III GLORIA AF registry, Early AF ablation within 3 months from initial diagnosis in a contemporary cohort of patients who were predominantly treated with non-vitamin K antagonist oral anticoagulants was associated with a survival advantage compared to medical therapy alone.
Moreover, early AF ablation appeared to provide the greatest benefit compared to other treatments.
The ATTEST trial was a multicenter, randomized, prospective study in patients with paroxysmal atrial fibrillation (AF) designed to assess whether radiofrequency (RF) ablation is more effective in delaying the progression to persistent AF than AADs.
Patients >_65 years were significantly more likely to progress to persistent AF/AT than patients were <65 years, suggesting that early RF ablation may be an effective treatment strategy for delaying AF progression.
So, we hypothesize that early AF ablation within one year after first AF diagnosis may associate with improved procedures outcomes in symptomatic AF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early referral to ablation within one year after first documented AF diagnosis | – | Procedure: Radiofrequency ablation |
| Delayed referral to ablation after one year after first documented AF diagnosis | – | Procedure: Radiofrequency ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We enroll all symptomatic AF patients who referred to first (de- novo) RF ablation within (early) vs. after (late) one year from the first AF diagnosis.
Key inclusion criteria (4 listed)
- Paroxysmal and persistent atrial fibrillation (AF) documented on a 12 lead ECG, trans-telephonic monitoring (TTM) or Holter monitor (episodes of AF must be >30 seconds in duration to qualify as an inclusion criterion)
- Age of 18 years or older on the date of consent.
- Candidate for ablation based on AF that is symptomatic
- Informed Consent
Key exclusion criteria (16 listed)
- Permenant AF
- Previous left atrial (LA) ablation or LA surgery
- AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
- Active intracardiac thrombus
- Pre-existing pulmonary vein stenosis or pulmonary vein stent
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 |
|---|---|---|
| Radiofrequency ablationpulmonary vein isolation using radiofrequency ablation. | Procedure or surgery | Delayed referral to ablation after one year after first documented AF diagnosis, Early referral to ablation within one year after first documented AF diagnosis |
Primary outcome
Freedom from any atrial arrhythmia after single ablation procedure.
Time frame: 12 months
freedom from any documented atrial arrhythmia lasted for more than 30 seconds.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Background: PubMed 33330909Kuck KH, Lebedev DS, Mikhaylov EN, Romanov A, Geller L, Kalejs O, Neumann T, Davtyan K, On YK, Popov S, Bongiorni MG, Schluter M, Willems S, Ouyang F. Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST). Europace. 2021 Mar 8;23(3):362-369. doi: 10.1093/europace/euaa298.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Radiofrequency Ablation, run by Assiut University.
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 16 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 29 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad A.A. Farghaly, MD (01007174534 ext. +2, ahmadabdelrady20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from any atrial arrhythmia after single ablation procedure. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05559073, which also lists 1 linked publication.
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 29 Sep 2022.