Persistent Atrial FibrillationNCT06633523
Optimized Posterior Left Atrial Wall Ablation Strategy for PeAF
A study testing PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM), PVI + Posterior Wall Isolation (PWI) and Pulmonary Vein Isolation (PVI) alone in people with Persistent Atrial Fibrillation, run by Shanghai Chest Hospital.
Trial summary
This is an open-label, multicenter, randomized parallel-controlled clinical trial. The study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (PsAF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM), PVI + Posterior Wall Isolation (PWI) and Pulmonary Vein Isolation (PVI) alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years.
- Patients undergoing their first ablation procedure for PsAF.
- Persistent atrial fibrillation (AF): Defined as episodes lasting ≥7 days and ≤3 years (including those requiring pharmacological or electrical cardioversion ≥7 days).
- Atrial fibrillation symptoms that are intolerant to at least one antiarrhythmic drug (AAD).
- At least one episode of PsAF must have been documented within the last 2 years by methods such as ECG, Holter monitoring, loop recorder, telemetry, remote telemonitoring (TTM), or implanted devices prior to enrollment in this study.
- Patients must be capable and willing to provide written informed consent to participate in the study.
- Patients must be willing and able to comply with all study follow-up requirements.
Who cannot join
- Paroxysmal AF: Defined as episodes lasting \<7 days (or resolved with medication/electrical cardioversion within \<7 days).
- Patients with long-standing persistent AF: Defined as persistent AF lasting \>3 years.
- Patients who have never attempted/pursued cardiac rhythm restoration or sinus rhythm.
- Contraindication to systemic anticoagulation.
- Pregnancy.
- Advanced renal or hepatic failure.
- Severe valvular heart disease or cyanotic congenital heart disease.
- Hypertrophic cardiomyopathy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimized Posterior Left Atrial Wall Ablation Strategy for Persistent Atrial Fibrillation: A Multicenter Large-Sample Clinical Study
This is an open-label, multicenter, randomized parallel-controlled clinical trial. The study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (PsAF).
Read the detailed description
This is an open-label, multicenter, randomized parallel-controlled clinical trial. The study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (PsAF).
The main content of the research includes comparing three approaches through randomization: pulmonary vein isolation (PVI) alone, PVI plus pulse field ablation (PWI), and PVI plus anatomical and potential-guided ablation, to evaluate their effects on reducing the recurrence rate of atrial fibrillation. The study is designed with three groups: the PVI-alone group, the PVI + PWI group, and the PVI plus anatomical and potential-guided ablation group.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM), PVI + Posterior Wall Isolation (PWI), Pulmonary Vein Isolation (PVI) alone
- Keywords
- pulmonary vein isolation, pulse field ablation, anatomical and potential-guided ablation, posterior left atrial wall 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.
PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM)Procedure or surgery
PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM) After performing PVI, electrogram mapping of the posterior left atrial wall is conducted. Subsequently, PWI and EGM ablation are performed. In this group, multipolar mapping catheters are used for EGM mapping. Target EGMs include spatially discrete potentials (STPs), localized short cycle length potentials (SCLPs), and focal activities.
PVI + Posterior Wall Isolation (PWI)Procedure or surgery
After performing PVI, the mapping catheter will be placed on the posterior wall to assess electrical activity and guide ablation. A bottom linear ablation (25-40W) will be performed, connecting the lowest points beneath the lower PVs. A top linear ablation (25-40W) will be conducted at the top of the left atrium, connecting the highest points above the upper PVs. If posterior wall isolation is not achieved after completing the bottom and top lines, mapping and localization of the earliest activation point within the box will be performed during pacing from the coronary sinus (CS). Posterior wall isolation will be completed by identifying and ablating local potentials at the entry and exit sites.
Pulmonary Vein Isolation (PVI) aloneProcedure or surgery
The distance between the ablation lines on the posterior wall after circumferential pulmonary vein isolation should be at least 2 centimeters to limit the portion of the posterior wall within the PVI ablation zone. PVI will be confirmed by verifying entrance and exit block at the PV orifices.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Vein Isolation (PVI) alone | Experimental | The distance between the ablation lines on the posterior wall after circumferential pulmonary vein isolation should be at least 2 centimeters to limit the portion of the posterior wall within the PVI ablation zone. PVI will be confirmed by verifying entrance and exit block at the PV orifices Receives: Procedure: PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM); Procedure: PVI + Posterior Wall Isolation (PWI) |
| Pulmonary Vein Isolation (PVI) + Posterior Wall Isolation (PWI) | Experimental | After performing PVI, the mapping catheter will be placed on the posterior wall to assess electrical activity and guide ablation. A bottom linear ablation (25-40W) will be performed, connecting the lowest points beneath the lower PVs. A top linear ablation (25-40W) will be conducted at the top of the left atrium, connecting the highest points above the upper PVs. If posterior wall isolation is not achieved after completing the bottom and top lines, mapping and localization of the earliest activation point within the box will be performed during pacing from the coronary sinus (CS). Posterior wall isolation will be completed by identifying and ablating local potentials at the entry and exit sites. Receives: Procedure: PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM); Procedure: Pulmonary Vein Isolation (PVI) alone |
| PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM) | Experimental | After performing PVI, electrogram mapping of the posterior left atrial wall is conducted. Subsequently, PWI and EGM ablation are performed. In this group, multipolar mapping catheters are used for EGM mapping. Target EGMs include spatially discrete potentials (STPs), localized short cycle length potentials (SCLPs), and focal activities. Receives: Procedure: PVI + Posterior Wall Isolation (PWI); Procedure: Pulmonary Vein Isolation (PVI) alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of atrial arrhythmias
Following a single ablation procedure, after discontinuation of antiarrhythmic drugs, there should be at least 12 months of follow-up without any documented episodes of atrial arrhythmias (atrial fibrillation [AF], atrial tachycardia [AT], or atrial flutter [AFL]) lasting more than 30 seconds, outside the initial 3-month blanking period.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Secondary outcomes (17)
no occurrence of any documented atrial fibrillation (AF) episode lasting more than 30 seconds
After a single ablation procedure, following the discontinuation of antiarrhythmic drugs, there is no occurrence of any documented atrial fibrillation (AF) episode lasting more than 30 seconds during at least 12 months of follow-up, excluding an initial 3-month blanking period.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
occurrence of any documented atrial arrhythmia lasting more than 30 seconds
After a single ablation procedure, with antiarrhythmic drugs either discontinued or not initiated, there is no occurrence of any documented atrial arrhythmia lasting more than 30 seconds during at least 12 months of follow-up, excluding an initial 3-month blanking period.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
the burden of atrial fibrillation at 12 months of follow-up between different study groups
After 1 to 2 ablation procedures, with antiarrhythmic drugs either discontinued or not initiated, excluding an initial 3-month blanking period, the burden of atrial fibrillation at 12 months of follow-up between different study groups.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
no occurrence of any documented atrial arrhythmia lasting more than 30 seconds
After 1 to 2 ablation procedures, with antiarrhythmic drugs either discontinued or not initiated, there is no occurrence of any documented atrial arrhythmia lasting more than 30 seconds during 12 months of follow-up, excluding an initial 3-month blanking period.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
no occurrence of any documented persistent atrial arrhythmia lasting more than 7 days
After 1 to 2 ablation procedures, with antiarrhythmic drugs either discontinued or not initiated, there is no occurrence of any documented persistent atrial arrhythmia lasting more than 7 days during 12 months of follow-up, excluding an initial 3-month blanking period.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
no occurrence of any documented symptomatic atrial fibrillation, flutter, or tachyarrhythmia lasting more than 30 seconds
Clinical success is defined as no occurrence of any documented symptomatic atrial fibrillation, flutter, or tachyarrhythmia lasting more than 30 seconds, excluding an initial 3-month blanking period, after the final follow-up and assessment of all ablation procedures.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Procedure duration / Fluoroscopy time / Radiofrequency ablation time
Measured: Record the duration of the surgery, fluoroscopy time, and radiofrequency ablation time immediately after the completion of the radiofrequency ablation procedure, measured in hours.
Posterior wall isolation success rate (bidirectional block).
Measured: Evaluate from the date of the procedure until the first documented recurrence of atrial arrhythmia, with a maximum assessment duration of 12 months.
Number of repeat procedures within at least 12 months of follow-up
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Number of direct current (DC) cardioversions performed due to atrial fibrillation recurrence within at least 12 months of follow-up.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Use of antiarrhythmic drugs at 3 months, at the time of atrial fibrillation recurrence, and at final follow-up.
Measured: Evaluate from 3 months post-procedure until the first documented recurrence of atrial fibrillation, with a maximum assessment duration of 12 months
Perioperative complications
Perioperative complications, including stroke, pulmonary vein stenosis, cardiac perforation, esophageal injury, and mortality.
Measured: Perioperative period
Quality of life assessments
Quality of life assessments within at least 12 months of follow-up using measures such as AF6.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Quality of life assessments
Quality of life assessments were conducted using the AFEQT (Atrial Fibrillation Effect on Quality of Life) questionnaire.
Measured: At least 12 months of follow-up, beyond the initial 3-month blanking period.
Psychological distress
Psychological distress was assessed using the HADS (Hospital Anxiety and Depression Scale)
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Functional status
Functional status was assessed using the CCS-SAF (Canadian Cardiovascular Society - Self-Assessed Functioning scale).
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Cardiac functional capacity
Cardiac functional capacity was assessed using the NYHA (New York Heart Association Functional Classification) within at least 12 months of follow-up, beyond the initial 3-month blanking period.
Measured: at least 12 months of follow-up, beyond the initial 3-month blanking period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Jan 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.
- 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
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dongfang Hospital Affiliated to Tongji University, Shanghai 10th People's Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
- Investigators
- Xumin Hou, Doctor, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633523
- Sponsor's protocol ID
- OPLAWAS-AF
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 9 Oct 2024
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Posterior Left Atrial Wall Ablation Strategy for Persistent Atrial Fibrillation: A Multicenter Large-Sample Clinical Study
- ClinicalTrials.gov ID
- NCT06633523
- Acronym / sponsor ID
- OPLAWAS-AF
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- pulmonary vein isolation, pulse field ablation, anatomical and potential-guided ablation, posterior left atrial wall ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Dongfang Hospital Affiliated to Tongji University, Shanghai 10th People's Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 9 Oct 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.
This is an open-label, multicenter, randomized parallel-controlled clinical trial. The study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (PsAF).
Detailed description
This is an open-label, multicenter, randomized parallel-controlled clinical trial. The study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (PsAF).
The main content of the research includes comparing three approaches through randomization: pulmonary vein isolation (PVI) alone, PVI plus pulse field ablation (PWI), and PVI plus anatomical and potential-guided ablation, to evaluate their effects on reducing the recurrence rate of atrial fibrillation. The study is designed with three groups: the PVI-alone group, the PVI + PWI group, and the PVI plus anatomical and potential-guided ablation group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Vein Isolation (PVI) alone | Experimental | Procedure: PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM), Procedure: PVI + Posterior Wall Isolation (PWI)The distance between the ablation lines on the posterior wall after circumferential pulmonary vein isolation should be at least 2 centimeters to limit the portion of the posterior wall within the PVI ablation zone. PVI will be confirmed by verifying entrance and exit block at the PV orifices |
| Pulmonary Vein Isolation (PVI) + Posterior Wall Isolation (PWI) | Experimental | Procedure: PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM), Procedure: Pulmonary Vein Isolation (PVI) aloneAfter performing PVI, the mapping catheter will be placed on the posterior wall to assess electrical activity and guide ablation. A bottom linear ablation (25-40W) will be performed, connecting the lowest points beneath the lower PVs. A top linear ablation (25-40W) will be conducted at the top of the left atrium, connecting the highest points above the upper PVs. If posterior wall isolation is not achieved after completing the bottom and top lines, mapping and localization of the earliest activation point within the box will be performed during pacing from the coronary sinus (CS). Posterior wall isolation will be completed by identifying and ablating local potentials at the entry and exit sites. |
| PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM) | Experimental | Procedure: PVI + Posterior Wall Isolation (PWI), Procedure: Pulmonary Vein Isolation (PVI) aloneAfter performing PVI, electrogram mapping of the posterior left atrial wall is conducted. Subsequently, PWI and EGM ablation are performed. In this group, multipolar mapping catheters are used for EGM mapping. Target EGMs include spatially discrete potentials (STPs), localized short cycle length potentials (SCLPs), and focal activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged ≥18 years.
- Patients undergoing their first ablation procedure for PsAF.
- Persistent atrial fibrillation (AF): Defined as episodes lasting ≥7 days and ≤3 years (including those requiring pharmacological or electrical cardioversion ≥7 days).
- Atrial fibrillation symptoms that are intolerant to at least one antiarrhythmic drug (AAD).
- At least one episode of PsAF must have been documented within the last 2 years by methods such as ECG, Holter monitoring, loop recorder, telemetry, remote telemonitoring (TTM), or implanted devices prior to enrollment in this study.
Key exclusion criteria (8 listed)
- Paroxysmal AF: Defined as episodes lasting \<7 days (or resolved with medication/electrical cardioversion within \<7 days).
- Patients with long-standing persistent AF: Defined as persistent AF lasting \>3 years.
- Patients who have never attempted/pursued cardiac rhythm restoration or sinus rhythm.
- Contraindication 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 |
|---|---|---|
| PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM)PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM) After performing PVI, electrogram mapping of the posterior left atrial wall is conducted. Subsequently, PWI and EGM ablation are performed. In this group, multipolar mapping catheters are used for EGM mapping. Target EGMs include spatially discrete potentials (STPs), localized short cycle length potentials (SCLPs), and focal activities. | Procedure or surgery | Pulmonary Vein Isolation (PVI) + Posterior Wall Isolation (PWI), Pulmonary Vein Isolation (PVI) alone |
| PVI + Posterior Wall Isolation (PWI)After performing PVI, the mapping catheter will be placed on the posterior wall to assess electrical activity and guide ablation. A bottom linear ablation (25-40W) will be performed, connecting the lowest points beneath the lower PVs. A top linear ablation (25-40W) will be conducted at the top of the left atrium, connecting the highest points above the upper PVs. If posterior wall isolation is not achieved after completing the bottom and top lines, mapping and localization of the earliest activation point within the box will be performed during pacing from the coronary sinus (CS). Posterior wall isolation will be completed by identifying and ablating local potentials at the entry and exit sites. | Procedure or surgery | PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM), Pulmonary Vein Isolation (PVI) alone |
| Pulmonary Vein Isolation (PVI) aloneThe distance between the ablation lines on the posterior wall after circumferential pulmonary vein isolation should be at least 2 centimeters to limit the portion of the posterior wall within the PVI ablation zone. PVI will be confirmed by verifying entrance and exit block at the PV orifices. | Procedure or surgery | PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM), Pulmonary Vein Isolation (PVI) + Posterior Wall Isolation (PWI) |
Primary outcome
recurrence of atrial arrhythmias
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Following a single ablation procedure, after discontinuation of antiarrhythmic drugs, there should be at least 12 months of follow-up without any documented episodes of atrial arrhythmias (atrial fibrillation [AF], atrial tachycardia [AT], or atrial flutter [AFL]) lasting more than 30 seconds, outside the initial 3-month blanking period.
17 secondary outcomes
no occurrence of any documented atrial fibrillation (AF) episode lasting more than 30 seconds
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
occurrence of any documented atrial arrhythmia lasting more than 30 seconds
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
the burden of atrial fibrillation at 12 months of follow-up between different study groups
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
no occurrence of any documented atrial arrhythmia lasting more than 30 seconds
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
no occurrence of any documented persistent atrial arrhythmia lasting more than 7 days
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
no occurrence of any documented symptomatic atrial fibrillation, flutter, or tachyarrhythmia lasting more than 30 seconds
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Procedure duration / Fluoroscopy time / Radiofrequency ablation time
Time frame: Record the duration of the surgery, fluoroscopy time, and radiofrequency ablation time immediately after the completion of the radiofrequency ablation procedure, measured in hours.
Posterior wall isolation success rate (bidirectional block).
Time frame: Evaluate from the date of the procedure until the first documented recurrence of atrial arrhythmia, with a maximum assessment duration of 12 months.
Number of repeat procedures within at least 12 months of follow-up
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Number of direct current (DC) cardioversions performed due to atrial fibrillation recurrence within at least 12 months of follow-up.
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Use of antiarrhythmic drugs at 3 months, at the time of atrial fibrillation recurrence, and at final follow-up.
Time frame: Evaluate from 3 months post-procedure until the first documented recurrence of atrial fibrillation, with a maximum assessment duration of 12 months
Perioperative complications
Time frame: Perioperative period
Quality of life assessments
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Quality of life assessments
Time frame: At least 12 months of follow-up, beyond the initial 3-month blanking period.
Psychological distress
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Functional status
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
Cardiac functional capacity
Time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period
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 9 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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, Doctor principal investigator
Shanghai Chest Hospital
Questions about this trial
What is this clinical trial studying?
A study testing PVI + Posterior Wall Isolation (PWI) + Electrogram Ablation (EGM), PVI + Posterior Wall Isolation (PWI) and Pulmonary Vein Isolation (PVI) alone in people with Persistent 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 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: opening soon, as of the sponsor's last update on 9 Oct 2024. 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?
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, Doctor (+8613052320103, qinmuae@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 arrhythmias (time frame: at least 12 months of follow-up, beyond the initial 3-month blanking period). 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 9 Oct 2024.