Atrial FibrillationNCT04958928
Termination of Persistent Atrial Fibrillation by Catheter Ablation
An observational study of Atrial Fibrillation, run by Shanghai Chest Hospital.
Trial summary
This is a prospective, multicenter, cohort study aims to demonstrate the role of termination of AF in ablation for persistent atrial fibrillation, and evaluate the clinical outcomes in patients with or without AF termination. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter ablation
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Aug 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: Patients with persistent AF.
Who may be able to join
- 1. Aged 18 to 80 years old; 2. Persistent AF; 3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.
Who cannot join
- With uncontrolled congestive heart failure;
- Having significant valvular disease and/or prosthetic heart valve(s);
- With myocardial infarction or stroke within 6 months of screening;
- With Significant congenital heart disease;
- Ejection fraction was <40% measured by echocardiography;
- Allergic to contrast media;
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- Contraindication to anticoagulation medications;
- Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
- Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;
- Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;
- 12. Presence of an implanted cardioverter-defibrillator; 13. Any cardiac surgery within the past 2 months; 14. Poor general health; 15.Life expectancy less than 6 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter, Cohort Study of Termination of Persistent Atrial Fibrillation by Catheter Ablation
This is a prospective, multicenter, cohort study aims to demonstrate the role of termination of AF in ablation for persistent atrial fibrillation, and evaluate the clinical outcomes in patients with or without AF termination.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter 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.
Catheter ablationProcedure or surgery
All patients received radiofrequncy ablation.
| Study group | Role | What they receive |
|---|---|---|
| Persistent AF Group | Not described Receives: Procedure: Catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF recurrence rate
AF recurrence is defined as presence of documented AF episodes of 30 recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.
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 posted12 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 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 Shanghai Chest HospitalThe 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
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Central Hospital, Ruijin Hospital, Beijing Chao Yang Hospital, The Third Xiangya Hospital of Central South University, The First Affiliated Hospital of Dalian Medical University, Xiamen Cardiovascular Hospital, Xiamen University, The Third People's Hospital of Chengdu
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958928
- Sponsor's protocol ID
- Termination-AF
- Status last verified
- Jul 2021
- First submitted
- 6 Jul 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Li K, Wu S, Wang X, Han B, Qin M, Hou X, Liu X. A multicenter, cohort study of catheter ablation for persistent atrial fibrillation with/without atrial fibrillation termination (the termination-atrial fibrillation study). Europace. 2024 Mar 30;26(4):euae085. doi: 10.1093/europace/euae085.
PubMed 38573506
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Cohort Study of Termination of Persistent Atrial Fibrillation by Catheter Ablation
- ClinicalTrials.gov ID
- NCT04958928
- Acronym / sponsor ID
- Termination-AF
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Wuhan Central Hospital, Ruijin Hospital, Beijing Chao Yang Hospital, The Third Xiangya Hospital of Central South University, The First Affiliated Hospital of Dalian Medical University, Xiamen Cardiovascular Hospital, Xiamen University, The Third People's Hospital of Chengdu
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 12 Jul 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.
This is a prospective, multicenter, cohort study aims to demonstrate the role of termination of AF in ablation for persistent atrial fibrillation, and evaluate the clinical outcomes in patients with or without AF termination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persistent AF Group | – | Procedure: Catheter ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent AF.
Key inclusion criteria (1 listed)
- 1. Aged 18 to 80 years old; 2. Persistent AF; 3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.
Key exclusion criteria (11 listed)
- With uncontrolled congestive heart failure;
- Having significant valvular disease and/or prosthetic heart valve(s);
- With myocardial infarction or stroke within 6 months of screening;
- With Significant congenital heart disease;
- Ejection fraction was <40% measured by echocardiography;
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 |
|---|---|---|
| Catheter ablationAll patients received radiofrequncy ablation. | Procedure or surgery | Persistent AF Group |
Primary outcome
AF recurrence rate
Time frame: 12 months
AF recurrence is defined as presence of documented AF episodes of 30 recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Derived from this study: PubMed 38573506Li K, Wu S, Wang X, Han B, Qin M, Hou X, Liu X. A multicenter, cohort study of catheter ablation for persistent atrial fibrillation with/without atrial fibrillation termination (the termination-atrial fibrillation study). Europace. 2024 Mar 30;26(4):euae085. doi: 10.1093/europace/euae085.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Shanghai Chest Hospital.
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 11 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 12 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Mu, MD (+8613052320103, qinmuae@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF recurrence rate (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 NCT04958928, 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 12 Jul 2021.