Atrial FibrillationNCT05921734
A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint in Patients With Persistent Atrial Fibrillation
A study testing AF-termination Group and Prespecified-ablation Group in people with Atrial Fibrillation and Cathter Ablation, run by Shanghai Chest Hospital at 2 sites in China.
Trial summary
This is a prospective, randomized, multi-center trial that aims to investigate whether termination of atrial fibrillation can be used as an ablation endpoint for persistent atrial fibrillation (PersAF). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Cathter Ablation, Endpoint
- What is being tested?
- AF-termination Group and Prespecified-ablation Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2023to 1 Aug 2025
- Phase
- Interventional
- 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
Who may be able to join
- . Age 18-80 years old.
- . Patients undergoing a first-time ablation procedure for PersAF.
- . Diagnosed as persistent AF according to the latest clinical guidelines.
- . Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment.
- . Patients must be able and willing to provide written informed consent to participate in this study.
Who cannot join
- . Uncontrolled congestive heart failure;
- . History of severe valve disease and/or prosthetic valve replacement;
- . Myocardial infarction or stroke within 6 months;
- . Severe congenital heart disease;
- . EF <35%;
- . Contrast agent allergy;
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- . The use of anticoagulant drugs is contraindicated;
- . Severe lung disease;
- . Left atrial thrombus confirmed by preoperative esophageal ultrasound;
- . Contraindications for cardiac catheterization;
- . Prior left atrial ablation (surgical or catheter);
- . Have performed any cardiac surgery within 2 months;
- . Poor general health;
- . Life expectancy < 12 months.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint Versus Prespecified Ablation Strategy Followed by Cardioversion in Patients With Persistent Atrial Fibrillation
This is a prospective, randomized, multi-center trial that aims to investigate whether termination of atrial fibrillation can be used as an ablation endpoint for persistent atrial fibrillation (PersAF). Eligible patients who provided consent were randomly assigned to one of two groups: the AF-termination group (whose ablation endpoint was the pursuit of AF-termination) or the prespecified-ablation group (whose ablation endpoint was prespecified ablation followed by electrical cardioversion).
- Conditions
- Atrial Fibrillation, Cathter Ablation, Endpoint
- Being tested
- AF-termination Group, Prespecified-ablation Group
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF-termination GroupProcedure or surgery
Each center completes the ablation according to the above ablation procedure. The choice of ablation strategy is not restricted, but efforts should be made to achieve termination of AF during the ablation procedure. If cannot terminate AF for safety or other reasons involving difficulties to remap AFEGM or creating a complete conduction block despite the operator's best efforts, then direct current conversion (DCCV) was performed.
Prespecified-ablation GroupProcedure or surgery
Each center completes the prespecified ablation according to the above ablation procedure. Although there is no restriction on the choice of ablation strategy, Ablation must be performed following the PVI plus strategy, which can be combined with one or more additional ablation procedures, but each ablation must achieve its own endpoints, such as bidirectional block of linear damage, posterior wall isolation, etc. After completing the preset ablation steps, DCCV will be performed. If AF is terminated after or during ablation, it is also considered the endpoint of ablation in this group, but the preset ablation steps must be completed.
| Study group | Role | What they receive |
|---|---|---|
| AF-termination Group | Experimental | Not described Receives: Procedure: AF-termination Group |
| Prespecified-ablation Group | Active comparator | Not described Receives: Procedure: Prespecified-ablation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period
All patients included in the study had no incidence of Atrial fibrillation (AF), atrial tachycardia (AT) or Atrial flutter (AFL) at 12 months after ablation, excluding the initial 3-month blank period
Measured: Time Frame: 12 months
Secondary outcomes (6)
freedom from AF/AT after a single procedure without AADs (excludes the blanking period)
All patients included in the study had no incidence of AF/AT after a single procedure without AADs at 12 months after ablation excluding the initial 3-month blank period
Measured: Time Frame: 12 months
freedom from AF/AT after a single procedure with or without anti-arrhythmic medications (excludes the blanking period)
All patients included in the study had no incidence of freedom from AF/AT after a single procedure with or without anti-arrhythmic medications at 12 months after ablation excluding the initial 3-month blank period
Measured: Time Frame: 12 months
any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment
All patients included in the study had no incidence of any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment at 12 months after ablation, excluding the initial 3-month blank period
Measured: Time Frame: 12 months
freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure
All patients included in the study had no incidence of any AT episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment at 12 months after ablation, excluding the initial 3-month blank period
Measured: Time Frame: 12 months
procedural details
All patients' procedural details: including procedure time, mapping time, fluoroscopy time, ablation time.
Measured: Time Frame: 12 months
incidence of periprocedural adverse events
All patients' periprocedural adverse events including：ascular- significant groin，haematoma, pseudoaneurysm, AV fistula，Cardiac perforation，Pericardial effusion/ tamponade，Pericarditis，Pneumothorax/ haemothorax，Phrenic nerve injury，Periprocedural cerebrovascular accident - including air embolism，Esophageal injury - perforation / atrio-esophageal fistula，Pulmonary vein stenosis，Major bleeding event -including retroperitoneal bleeding，Heart block，Death
Measured: Time Frame: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2025
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921734
- Sponsor's protocol ID
- CAPT-AF
- Status last verified
- Jun 2023
- First submitted
- 10 Jun 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint Versus Prespecified Ablation Strategy Followed by Cardioversion in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05921734
- Acronym / sponsor ID
- CAPT-AF
- Conditions
- Atrial Fibrillation, Cathter Ablation, Endpoint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 27 Jun 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.
This is a prospective, randomized, multi-center trial that aims to investigate whether termination of atrial fibrillation can be used as an ablation endpoint for persistent atrial fibrillation (PersAF). Eligible patients who provided consent were randomly assigned to one of two groups: the AF-termination group (whose ablation endpoint was the pursuit of AF-termination) or the prespecified-ablation group (whose ablation endpoint was prespecified ablation followed by electrical cardioversion).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF-termination Group | Experimental | Procedure: AF-termination Group |
| Prespecified-ablation Group | Active comparator | Procedure: Prespecified-ablation Group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- . Age 18-80 years old.
- . Patients undergoing a first-time ablation procedure for PersAF.
- . Diagnosed as persistent AF according to the latest clinical guidelines.
- . Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment.
- . Patients must be able and willing to provide written informed consent to participate in this study.
Key exclusion criteria (14 listed)
- . Uncontrolled congestive heart failure;
- . History of severe valve disease and/or prosthetic valve replacement;
- . Myocardial infarction or stroke within 6 months;
- . Severe congenital heart disease;
- . EF <35%;
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 |
|---|---|---|
| AF-termination GroupEach center completes the ablation according to the above ablation procedure. The choice of ablation strategy is not restricted, but efforts should be made to achieve termination of AF during the ablation procedure. If cannot terminate AF for safety or other reasons involving difficulties to remap AFEGM or creating a complete conduction block despite the operator's best efforts, then direct current conversion (DCCV) was performed. | Procedure or surgery | AF-termination Group |
| Prespecified-ablation GroupEach center completes the prespecified ablation according to the above ablation procedure. Although there is no restriction on the choice of ablation strategy, Ablation must be performed following the PVI plus strategy, which can be combined with one or more additional ablation procedures, but each ablation must achieve its own endpoints, such as bidirectional block of linear damage, posterior wall isolation, etc. After completing the preset ablation steps, DCCV will be performed. If AF is terminated after or during ablation, it is also considered the endpoint of ablation in this group, but the preset ablation steps must be completed. | Procedure or surgery | Prespecified-ablation Group |
Primary outcome
freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period
Time frame: Time Frame: 12 months
All patients included in the study had no incidence of Atrial fibrillation (AF), atrial tachycardia (AT) or Atrial flutter (AFL) at 12 months after ablation, excluding the initial 3-month blank period
6 secondary outcomes
freedom from AF/AT after a single procedure without AADs (excludes the blanking period)
Time frame: Time Frame: 12 months
freedom from AF/AT after a single procedure with or without anti-arrhythmic medications (excludes the blanking period)
Time frame: Time Frame: 12 months
any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs (AADs) treatment
Time frame: Time Frame: 12 months
freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure
Time frame: Time Frame: 12 months
procedural details
Time frame: Time Frame: 12 months
incidence of periprocedural adverse events
Time frame: Time Frame: 12 months
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 12 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF-termination Group and Prespecified-ablation Group in people with Atrial Fibrillation and Cathter Ablation, run by Shanghai Chest Hospital at 2 sites 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 14 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period (time frame: Time Frame: 12 months). 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 12 Sep 2025.