Persistent Atrial FibrillationNCT07122336
Optimized Ablation of the Posterior Wall in Persistent Atrial Fibrillation
A study testing PVI, PWI and EGM in people with Persistent Atrial Fibrillation, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The design of this study is an intervention, randomized, controlled study and contains three randomized groups：（1）PVI group；（2）PVI+PWI group;（3）PVI+PWI+EGM group. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- PVI, PWI and EGM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- First-time ablation for persistent atrial fibrillation (PsAF)
- Persistent AF definition: Sustained episodes lasting ≥7 days but ≤3 years (including episodes requiring pharmacologic or electrical cardioversion after ≥7 days)
- Symptomatic AF with intolerance to at least one antiarrhythmic drug (AAD)
- Documented PsAF episode: At least one recorded PsAF episode within the last 2 years prior to enrollment, confirmed by: ECG,Holter monitorin, Loop recorder, Telemetry, Transtelephonic monitoring (TTM),Implantable device
- Ability and willingness to provide written informed consent
- Compliance with all study follow-up requirements
Who cannot join
- Paroxysmal AF: Episodes lasting <7 days (or requiring pharmacologic/electrical cardioversion <7 days)
- Long-standing persistent AF: Continuous AF duration >3 years
- No prior attempt/pursuit of cardioversion or sinus rhythm maintenance
- Contraindications to systemic anticoagulation
- Pregnancy
- Advanced renal or hepatic failure
- Severe valvular heart disease or cyanotic congenital heart disease
- Hypertrophic cardiomyopathy (HCM)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xumin Hou contact
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai
Mu Qin, 13052320103, qinmuae@163.com
About this study
The design of this study is an intervention, randomized, controlled study and contains three randomized groups：（1）PVI group；（2）PVI+PWI group;（3）PVI+PWI+EGM group.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- PVI, PWI, EGM
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVIProcedure or surgery
PVI
PWIProcedure or surgery
PWI
EGMProcedure or surgery
EGM
| Study group | Role | What they receive |
|---|---|---|
| PVI group | Sham comparator | PVI Receives: Procedure: PVI |
| PVI+ PWI group | Experimental | PVI+ PWI Receives: Procedure: PVI; Procedure: PWI |
| PVI+ PWI+EGM group | Experimental | PVI+ PWI+EGM Receives: Procedure: PVI; Procedure: PWI; Procedure: EGM |
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, at a minimum of 12 months follow up after a single ablat
Measured: 12 months
Secondary outcomes (9)
Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months
Measured: 12 months
Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure
Measured: 12 months
The atrial fibrillation burden among study groups at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs.
Measured: 12 months
Freedom from any documented atrial arrhythmia episodes lasting >30 seconds at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs (AADs)
Measured: 12 months
Freedom from any documented sustained atrial arrhythmia episodes lasting >7 days at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without antiarrhythmic drug therapy
Measured: 12 months
freedom from any documented symptomatic atrial fibrillation/flutter/tachycardia episodes (>30 seconds) after assessment of all ablation procedures at final follow-up, excluding the initial 3-month blanking period.
Measured: 12 months
Procedure time / Fluoroscopy time / ablation time
Measured: 12 months
Periprocedural complications, including stroke, pulmonary vein stenosis, cardiac perforation, esophageal injury, and mortality.
Measured: 12 months
Quality of life assessments during ≥12-month follow-up (AFEQT)
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 posted14 Aug 2025
- Study start16 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 384 participants (estimated)
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
- NCT07122336
- Sponsor's protocol ID
- OAPWAF
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 14 Aug 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 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Ablation of the Posterior Wall in Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07122336
- Acronym / sponsor ID
- OAPWAF
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Aug 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.
The design of this study is an intervention, randomized, controlled study and contains three randomized groups：（1）PVI group；（2）PVI+PWI group;（3）PVI+PWI+EGM group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PVI group | Sham comparator | Procedure: PVIPVI |
| PVI+ PWI group | Experimental | Procedure: PVI, Procedure: PWIPVI+ PWI |
| PVI+ PWI+EGM group | Experimental | Procedure: PVI, Procedure: PWI, Procedure: EGMPVI+ PWI+EGM |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- First-time ablation for persistent atrial fibrillation (PsAF)
- Persistent AF definition: Sustained episodes lasting ≥7 days but ≤3 years (including episodes requiring pharmacologic or electrical cardioversion after ≥7 days)
- Symptomatic AF with intolerance to at least one antiarrhythmic drug (AAD)
- Documented PsAF episode: At least one recorded PsAF episode within the last 2 years prior to enrollment, confirmed by: ECG,Holter monitorin, Loop recorder, Telemetry, Transtelephonic monitoring (TTM),Implantable device
Key exclusion criteria (8 listed)
- Paroxysmal AF: Episodes lasting <7 days (or requiring pharmacologic/electrical cardioversion <7 days)
- Long-standing persistent AF: Continuous AF duration >3 years
- No prior attempt/pursuit of cardioversion or sinus rhythm maintenance
- Contraindications to systemic anticoagulation
- Pregnancy
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 |
|---|---|---|
| PVIPVI | Procedure or surgery | PVI group, PVI+ PWI group, PVI+ PWI+EGM group |
| PWIPWI | Procedure or surgery | PVI+ PWI group, PVI+ PWI+EGM group |
| EGMEGM | Procedure or surgery | PVI+ PWI+EGM 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, at a minimum of 12 months follow up after a single ablat
Time frame: 12 months
9 secondary outcomes
Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months
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: 12 months
The atrial fibrillation burden among study groups at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs.
Time frame: 12 months
Freedom from any documented atrial arrhythmia episodes lasting >30 seconds at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without discontinuation of antiarrhythmic drugs (AADs)
Time frame: 12 months
Freedom from any documented sustained atrial arrhythmia episodes lasting >7 days at 12-month follow-up (excluding the initial 3-month blanking period) after 1 to 2 ablation procedures, with or without antiarrhythmic drug therapy
Time frame: 12 months
freedom from any documented symptomatic atrial fibrillation/flutter/tachycardia episodes (>30 seconds) after assessment of all ablation procedures at final follow-up, excluding the initial 3-month blanking period.
Time frame: 12 months
Procedure time / Fluoroscopy time / ablation time
Time frame: 12 months
Periprocedural complications, including stroke, pulmonary vein stenosis, cardiac perforation, esophageal injury, and mortality.
Time frame: 12 months
Quality of life assessments during ≥12-month follow-up (AFEQT)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 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.
Xumin Hou contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI, PWI and EGM in people with 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mu Qin (13052320103, qinmuae@163.com), or a site near the patient. 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, at a minimum of 12 months follow up after a single ablat (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 14 Aug 2025.