Recurrent Persistent Atrial FibrillationNCT06829446
Recurrent Persistent Atrial Fibrillation:In-situ Ablation Vs Extensive Ablation
A study testing Extra-PV extensive ablation and Repeat same PVI and linear ablation as the first procedure in people with Recurrent Persistent Atrial Fibrillation, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This is an open label, randomized parallel control clinical trial, to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Persistent Atrial Fibrillation
- What is being tested?
- Extra-PV extensive ablation and Repeat same PVI and linear ablation as the first procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older; 2) Diagnosed as recurrent PerAF according to the latest clinical guidelines; 3) Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment; 4) the first ablation procedure was PVI and linear ablation; 5) consented to receive radiofrequency catheter ablation.
Who cannot join
- 1) Recurrent atrial flutter/atrial tachycardia; 2) The first ablation procedure included extra-PV substrate ablation; 3) The first low voltage area>30%; 4) Serious complications during the first procedure; 5) The first ablation was paroxysmal atrial fibrillation. 6) Uncontrolled congestive heart failure; 7) History of severe valve disease and/or prosthetic valve replacement; 8) Left atrial thrombus confirmed by preoperative esophageal ultrasound; 9) Severe congenital heart disease; 10) Severe lung disease; 11) Left atrial diameter ≥60mm; 12) Contraindications for cardiac catheterization; 13) Myocardial infarction or stroke within 6 months; 14) Contrast agent allergy; 15) The use of anticoagulant drugs is contraindicated; 16) Have performed any cardiac surgery within 2 months;17) life expectancy is less than one year, including factors such as physical inability to tolerate ablation or unstable disease conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Study of Repeat In-situ Ablation Versus Extensive Ablation for Patients with Recurrent Persistent Atrial Fibrillation
This is an open label, randomized parallel control clinical trial, to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence.
Read the detailed description
This is an open label, randomized parallel control clinical trial. Patients with recurrent persistent atrial fibrillation are 1:1 randomized into EXT group(Extra-PV extensive ablation) and IN-SITU group(Repeat same PVI and linear ablation as the first procedure). Postoperative recurrence rate and other indicators are analyzed to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence.
- Conditions
- Recurrent Persistent Atrial Fibrillation
- Being tested
- Extra-PV extensive ablation, Repeat same PVI and linear ablation as the first procedure
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-PV extensive ablationProcedure or surgery
Extra-PV extensive ablation
Repeat same PVI and linear ablation as the first procedureProcedure or surgery
Repeat same PVI and linear ablation as the first procedure
| Study group | Role | What they receive |
|---|---|---|
| EXT group | Experimental | Not described Receives: Procedure: Extra-PV extensive ablation; Procedure: Repeat same PVI and linear ablation as the first procedure |
| IN-SITU group | Sham comparator | Not described Receives: Procedure: Extra-PV extensive ablation; Procedure: Repeat same PVI and linear ablation as the first procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from any documented AF/AT episode
Freedom from any documented AF/AT episode lasting more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months' follow-up after a single ablation procedure without antiarrhythmic medication.
Measured: 12 months
Secondary outcomes (3)
Freedom from any documented AF episode
Freedom from any documented AF episode lasting more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months' follow-up after a single ablation procedure without antiarrhythmic medication
Measured: 12 months
Any documented AT episode
Any documented AT episode lasting more than 30 seconds excluding the initial 3 months blanking period, at a minimum of 12 months' follow-up after a single ablation procedure without antiarrhythmic medication
Measured: 12 months
Periprocedural complications
Periprocedural complications,including stroke, PV stenosis, cardiac perforation, oesophageal injury and death.
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 posted17 Feb 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Persistent 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jinshan Hospital Affiliated to Fudan University, Tongji University
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829446
- Sponsor's protocol ID
- RIEAF
- Status last verified
- Jan 2022
- First submitted
- 11 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Study of Repeat In-situ Ablation Versus Extensive Ablation for Patients with Recurrent Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06829446
- Acronym / sponsor ID
- RIEAF
- Conditions
- Recurrent Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Jinshan Hospital Affiliated to Fudan University, Tongji University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Feb 2025 (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 an open label, randomized parallel control clinical trial, to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence.
Detailed description
This is an open label, randomized parallel control clinical trial. Patients with recurrent persistent atrial fibrillation are 1:1 randomized into EXT group(Extra-PV extensive ablation) and IN-SITU group(Repeat same PVI and linear ablation as the first procedure). Postoperative recurrence rate and other indicators are analyzed to compare extra-PV extensive ablation with in-situ ablation as two strategies for the treatment of PerAF to identify the mechanisms of PerAF recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXT group | Experimental | Procedure: Extra-PV extensive ablation, Procedure: Repeat same PVI and linear ablation as the first procedure |
| IN-SITU group | Sham comparator | Procedure: Extra-PV extensive ablation, Procedure: Repeat same PVI and linear ablation as the first procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years or older; 2) Diagnosed as recurrent PerAF according to the latest clinical guidelines; 3) Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment; 4) the first ablation procedure was PVI and linear ablation; 5) consented to receive radiofrequency catheter ablation.
Key exclusion criteria (1 listed)
- 1) Recurrent atrial flutter/atrial tachycardia; 2) The first ablation procedure included extra-PV substrate ablation; 3) The first low voltage area>30%; 4) Serious complications during the first procedure; 5) The first ablation was paroxysmal atrial fibrillation. 6) Uncontrolled congestive heart failure; 7) History of severe valve disease and/or prosthetic valve replacement; 8) Left atrial thrombus confirmed by preoperative esophageal ultrasound; 9) Severe congenital heart disease; 10) Severe lung disease; 11) Left atrial diameter ≥60mm; 12) Contraindications for cardiac catheterization; 13) Myocardial infarction or stroke within 6 months; 14) Contrast agent allergy; 15) The use of anticoagulant drugs is contraindicated; 16) Have performed any cardiac surgery within 2 months;17) life expectancy is less than one year, including factors such as physical inability to tolerate ablation or unstable disease conditions.
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 |
|---|---|---|
| Extra-PV extensive ablationExtra-PV extensive ablation | Procedure or surgery | EXT group, IN-SITU group |
| Repeat same PVI and linear ablation as the first procedureRepeat same PVI and linear ablation as the first procedure | Procedure or surgery | EXT group, IN-SITU group |
Primary outcome
Freedom from any documented AF/AT episode
Time frame: 12 months
Freedom from any documented AF/AT episode lasting more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months' follow-up after a single ablation procedure without antiarrhythmic medication.
3 secondary outcomes
Freedom from any documented AF episode
Time frame: 12 months
Any documented AT episode
Time frame: 12 months
Periprocedural complications
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 17 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra-PV extensive ablation and Repeat same PVI and linear ablation as the first procedure in people with Recurrent Persistent Atrial Fibrillation, run by Shanghai Chest Hospital 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 1 inclusion and 1 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 17 Feb 2025. 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. Some participants in this study may receive a placebo. 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 AF/AT episode (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 17 Feb 2025.