Persisent Atrial FibrillationSAFE-AF-ABLNCT06523738
Left Atrial Volume Changes Who Underwent Cardioversion and Recurrence of AF After RF Ablation in Persistent AF (SAFE-AF)
An observational study of Persisent Atrial Fibrillation and Reversal of Atrial Enlargement, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Electrical/pharmacological cardioversion improves structural remodeling of left atrium. We hypothesize that persistent atrial fibrillation (AF) patients with more significant left atrial size reduction after cardioversion have lower AF recurrence rates following radiofrequency ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persisent Atrial Fibrillation, Reversal of Atrial Enlargement, Recurrence of Atrial Fibrillation
- What is being tested?
- 1. electrical/pharmacological cardioversion. 2.pulmonary vein isolation
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 31 Dec 2025
- How long will I take part?
- 24 Months
- 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: Persistent atrial fibrillation patients with enlarged left atrium.
Who may be able to join
- Patients with estabolished diagnosis of Persistent Atrial Fibrillation during past 6 mnths.
- LAD brfore entering the two cohorts is more than 40mm, and less than 50mm.
- Pharmacological or electrical cardioversion has be performed successfully.
- At least two echocardiograms were performed before and 3-6 months after cardioversion., and confirm the status of LAD (Reversal, unchange, enlargment).
- Patients have given informed consent.
Who cannot join
- Prior radiofrequency ablation treatment for atrial fibrillation
- Prior cardiac surgical procedures
- Individuals with cognitive impairments who are unable to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400072
Yuehui Yin, MD, +8613508335502, yinyh@hospital.cqmu.edu.cn, yinyh63@163.com
Fang Qin, +8617308351199, qinfangheart@126.com
About this study
Official title: Association of Left Atrial Volume Changes After Cardioversion and Recurrence of Atrial Fibrillation After Radiofrequency Ablation in Patients With Persistent Atrial Fibrillation
Electrical/pharmacological cardioversion improves structural remodeling of left atrium. We hypothesize that persistent atrial fibrillation (AF) patients with more significant left atrial size reduction after cardioversion have lower AF recurrence rates following radiofrequency ablation. The aim is to evaluate the relationship between changes in left atrial size 3 to 6 months after cardioversion and the recurrence rate of atrial fibrillation following radiofrequency ablation.
Read the detailed description
Background: Atrial fibrillation (AF) is estimated to affect over 33 million people worldwide and is associated with significant co-morbidities such as embolic stroke, heart failure, dementia. Consequently, AF poses a significant burden to the healthcare system, in both direct and indirect costs. The management of AF is complex, especially for patients with persistent AF, which is defined as sustained AF for > 7 days. It is preferable to terminate the AF and restore normal sinus rhythm for relief of symptoms associated with AF or improvement of cardiac structure and function. The maintenance of AF, especially persistent AF is associated with fibrosis of left atria. Furthermore, AF itself promotes fibrosis, which in turn leads to increased conduction heterogeneity within the atrial substrate resulting in further progression of AF. In animal models, alterations in myocytes after sustained AF resemble those of myocardial hibernation. Ultimately, these structural changes would lead to Calcium overload and metabolic stress, similar changes have been observed in humans. In humans, atrial dilatation and degenerative changes have been observed. Interstitial fibrosis is the prime cause of structural remodeling in left atrium. In AF patients who did not experience AF recurrence after catheter ablation, the reduction in left atrial size was more significant. In the past, a 15% reduction in left atrial volume has been defined as left atrial reverse remodeling and is associated with the maintenance of sinus rhythm after AF ablation. It remains unclear whether the reduction in left atrial size after the restoration of sinus rhythm through electrical or pharmacological cardioversion in patients with persistent AF can predict AF recurrence following radiofrequency ablation.
Objectives: To evaluate the relationship between changes in left atrial size 3-6 months after electrical or pharmacological cardioversion in patients with persistent AF and AF recurrence within one year following radiofrequency ablation.
Methods: This study will be an observational trial of patients with persistent AF. Candidates will be identified among inpatients or outpatients if they have had at least two echocardiograms, one before and one 3-6 months after pharmacological or electrical cardioversion. Heart rhythm will be assessed through medical records and telephone surveys.
- Conditions
- Persisent Atrial Fibrillation, Reversal of Atrial Enlargement, Recurrence of Atrial Fibrillation
- Being tested
- 1. electrical/pharmacological cardioversion. 2.pulmonary vein isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. electrical/pharmacological cardioversion. 2.pulmonary vein isolationDiagnostic test
- electrical/pharmacological cardioversion. 2. pulmonary vein isolation for persistent atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Reversible Group | Left atrial volume (LAV) decreased by 15% 3 to 6 months after electrical/pharmacological cardioversion compared to baseline. Consequently, patients in the group will receive pulmonary vein isolation only. Receives: Diagnostic Test: 1. electrical/pharmacological cardioversion. 2.pulmonary vein isolation | |
| Irreversible Group | Left atrial volume (LAV) decreased by less than 15% 3 to 6 months after electrical/pharmacological cardioversion compared to baseline. Patients in the group will receive pulmonary vein isolation only. Receives: Diagnostic Test: 1. electrical/pharmacological cardioversion. 2.pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial fibrillation
Recurrence of atrial fibrillation after radiofrequency ablation
Measured: 1, 3, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Jul 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persisent 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
- 24 Months
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523738
- Sponsor's protocol ID
- SAFE-AF-ABL
- Acronym
- SAFE-AF-ABL
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 26 Jul 2024
- 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 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Left Atrial Volume Changes After Cardioversion and Recurrence of Atrial Fibrillation After Radiofrequency Ablation in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06523738
- Acronym / sponsor ID
- SAFE-AF-ABL / SAFE-AF-ABL
- Conditions
- Persisent Atrial Fibrillation, Reversal of Atrial Enlargement, Recurrence of Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jul 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.
Electrical/pharmacological cardioversion improves structural remodeling of left atrium. We hypothesize that persistent atrial fibrillation (AF) patients with more significant left atrial size reduction after cardioversion have lower AF recurrence rates following radiofrequency ablation. The aim is to evaluate the relationship between changes in left atrial size 3 to 6 months after cardioversion and the recurrence rate of atrial fibrillation following radiofrequency ablation.
Detailed description
Background: Atrial fibrillation (AF) is estimated to affect over 33 million people worldwide and is associated with significant co-morbidities such as embolic stroke, heart failure, dementia. Consequently, AF poses a significant burden to the healthcare system, in both direct and indirect costs. The management of AF is complex, especially for patients with persistent AF, which is defined as sustained AF for > 7 days. It is preferable to terminate the AF and restore normal sinus rhythm for relief of symptoms associated with AF or improvement of cardiac structure and function. The maintenance of AF, especially persistent AF is associated with fibrosis of left atria. Furthermore, AF itself promotes fibrosis, which in turn leads to increased conduction heterogeneity within the atrial substrate resulting in further progression of AF. In animal models, alterations in myocytes after sustained AF resemble those of myocardial hibernation. Ultimately, these structural changes would lead to Calcium overload and metabolic stress, similar changes have been observed in humans. In humans, atrial dilatation and degenerative changes have been observed. Interstitial fibrosis is the prime cause of structural remodeling in left atrium. In AF patients who did not experience AF recurrence after catheter ablation, the reduction in left atrial size was more significant. In the past, a 15% reduction in left atrial volume has been defined as left atrial reverse remodeling and is associated with the maintenance of sinus rhythm after AF ablation. It remains unclear whether the reduction in left atrial size after the restoration of sinus rhythm through electrical or pharmacological cardioversion in patients with persistent AF can predict AF recurrence following radiofrequency ablation.
Objectives: To evaluate the relationship between changes in left atrial size 3-6 months after electrical or pharmacological cardioversion in patients with persistent AF and AF recurrence within one year following radiofrequency ablation.
Methods: This study will be an observational trial of patients with persistent AF. Candidates will be identified among inpatients or outpatients if they have had at least two echocardiograms, one before and one 3-6 months after pharmacological or electrical cardioversion. Heart rhythm will be assessed through medical records and telephone surveys.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reversible Group | – | Diagnostic Test: 1. electrical/pharmacological cardioversion. 2.pulmonary vein isolationLeft atrial volume (LAV) decreased by 15% 3 to 6 months after electrical/pharmacological cardioversion compared to baseline. Consequently, patients in the group will receive pulmonary vein isolation only. |
| Irreversible Group | – | Diagnostic Test: 1. electrical/pharmacological cardioversion. 2.pulmonary vein isolationLeft atrial volume (LAV) decreased by less than 15% 3 to 6 months after electrical/pharmacological cardioversion compared to baseline. Patients in the group will receive pulmonary vein isolation only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persistent atrial fibrillation patients with enlarged left atrium.
Key inclusion criteria (5 listed)
- Patients with estabolished diagnosis of Persistent Atrial Fibrillation during past 6 mnths.
- LAD brfore entering the two cohorts is more than 40mm, and less than 50mm.
- Pharmacological or electrical cardioversion has be performed successfully.
- At least two echocardiograms were performed before and 3-6 months after cardioversion., and confirm the status of LAD (Reversal, unchange, enlargment).
- Patients have given informed consent.
Key exclusion criteria (3 listed)
- Prior radiofrequency ablation treatment for atrial fibrillation
- Prior cardiac surgical procedures
- Individuals with cognitive impairments who are unable to give informed consent
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 |
|---|---|---|
| 1. electrical/pharmacological cardioversion. 2.pulmonary vein isolation1. electrical/pharmacological cardioversion. 2. pulmonary vein isolation for persistent atrial fibrillation | Diagnostic test | Irreversible Group, Reversible Group |
Primary outcome
Recurrence of atrial fibrillation
Time frame: 1, 3, 5 years
Recurrence of atrial fibrillation after radiofrequency ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Persisent Atrial Fibrillation
Not yet recruitingObservational study
Conduction Breakthrough in the Coronary Sinus Post Endocardial Mitral Isthmus Ablation
Atrial Fibrillation (AF), Atrial Tachycardia
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 Persisent Atrial Fibrillation and Reversal of Atrial Enlargement, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 5 inclusion and 3 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 26 Jul 2024. 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 China. 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 Yuehui Yin, MD (+8613508335502, yinyh@hospital.cqmu.edu.cn; yinyh63@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial fibrillation (time frame: 1, 3, 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 26 Jul 2024.