Persistent Atrial FibrillationNCT07106970
PVI Alone vs PVI and Linear Ablation for Persistent Atrial Fibrillation (PROMPT AF II)
A study testing Linear ablation and PVI alone in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation at 1 site in China.
Trial summary
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Linear ablation and PVI alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2025to 30 Aug 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study subjects are required to meet all the following inclusion criteria:
- Subjects with an age range of 18 years or above and 80 years or below.
- Subjects have symptomatic, drug-resistant, persistent AF, defined as:
- Symptomatic: these symptoms include but not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath.
- Drug-resistant: effectiveness failure of, intolerance to, or specific contraindication to at least one AAD.
- Persistent: continuous AF for > 90 days, i) with a minimum a physician's note confirming the diagnosis AND,within 180 days of Enrollment Date, either a 24-hour or longer continuous ECG recording confirming continuous AF OR Two ECGs showing continuous AF taken at least 90 days apart.
- Subjects undergoing a first-time ablation procedure for AF.
- Subjects who are willing and capable of providing ICF and participating in all testing associated with this study.
Who cannot join
- AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
- Left atrial anteroposterior diameter ≥ 6.0 cm by transthoracic echocardiography (TTE) within 3 months prior the procedure.
- Heart failure with left ventricular ejection fraction (LVEF) < 30% by TTE within 3 months prior the procedure.
- LA thrombus detected by Transesophageal Echocardiography (TEE) or cardiac CT within one day before the procedure or Intracardiac Echocardiography (ICE) before atrial septal puncture during the procedure.
- Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, mechanical valve, interatrial baffle, closure device, patch, or patent foramen oval occlude, left atrial appendage closure at the time of ablation.
- Any of the following events within 90 days of the Consent Date:
Show all 16Show fewer
- Myocardial infarction, unstable angina or coronary intervention or any cardiac surgery
- Pericarditis or symptomatic pericardial effusion
- Gastrointestinal bleeding
- Stroke, transient ischemic attack (TIA), or intracranial bleeding or any non-neurologic thromboembolic event
- Contraindication to, or unwillingness to use systemic anticoagulation.
- Subjects cannot be removed from Class I/III AAD for reasons other than atrial arrhythmia.
- Women of childbearing potential who are pregnant or lactating.
- Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL/min/1.73 m2, or with any history of renal dialysis or renal transplant.
- Conditions that in the investigator's medical opinion would interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.
- Predicted life expectancy less than 12 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, affiliated to Capital Medical University
Beijing, 101118
Caihua Sang, Doctor
About this study
Official title: Linear Ablation Added to Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone Using Pulsed Field Ablation for Persistent Atrial Fibrillation: a Multi-center Randomized Controlled Trial
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF)
Read the detailed description
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to PVI outperforms PVI alone using PFA in maintaining sinus rhythm for PerAF. Enrolled subjects will be randomized by the ratio of 1:1 into PVI and linear ablation arm or PVI alone arm. Subjects in PVI and linear ablation arm will undergo bilateral PVI, and linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device and EIVOM could be performed additionally before or after PFA at the operator's discretion, it is recommended to perform EIVOM first. Subjects randomized to the PVI alone arm will undergo PVI only. If atrial fibrillation (AF) cannot be terminated during ablation, cardioversion will be performed. After ablation, all the subjects will be followed at discharge, 1 month and then at 3-month intervals up to 12 months.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Linear ablation, PVI alone
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear ablationProcedure or surgery
Linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device.EIVOM could be performed additionally before or after PFA at the operator's discretion.
PVI aloneProcedure or surgery
Undergo PVI with the study device
| Study group | Role | What they receive |
|---|---|---|
| PVI and linear ablation arm | Experimental | Subjects in PVI and linear ablation arm will undergo bilateral PVI, and linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device, and EIVOM could be performed additionally before or after PFA at the operator's discretion. Receives: Procedure: Linear ablation; Procedure: PVI alone |
| PVI alone arm | Active comparator | Subjects randomized to the PVI alone arm will undergo PVI only with the study device. Receives: Procedure: PVI alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint with Treatment Success.
Number of Participants free from Arrhythmia, Re-ablation, Cardioversion, and AAD use.
Measured: Completion of treatment 360 days compared with the baseline
Primary Safety Endpoint with Safety events related to AF catheter ablation.
Number of Participants with following device or procedure-related serious Composite Adverse Events (CAEs).
Measured: Completion of treatment 360 days compared with the baseline
Secondary outcomes (2)
Secondary Effectiveness Endpoint with Chronic Success.
Number of Participants with Chronic Success, Freedom from any documented AF, AFL or AT episode lasting ≥10s via 12-lead ECG or ≥30s via Holter (or other continuous rhythm monitoring device) on/off AADs after the blanking period to Day 360.
Measured: Completion of treatment 360 days compared with the baseline.
Secondary Safety Endpoint with Non-SAE.
Number of Participants with Non-Serious Composite Adverse Event
Measured: Completion of treatment 360 days compared with the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start28 Aug 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Aug 2028 (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 Boston Scientific CorporationThe 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
- Model description
- This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changsheng Ma, Doctor, Principal investigator, Beijing Anzhen Hospital of the Capital University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106970
- Sponsor's protocol ID
- PF336
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linear Ablation Added to Pulmonary Vein Isolation Versus Pulmonary Vein Isolation Alone Using Pulsed Field Ablation for Persistent Atrial Fibrillation: a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07106970
- Acronym / sponsor ID
- PF336
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 6 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.
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF)
Detailed description
This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to PVI outperforms PVI alone using PFA in maintaining sinus rhythm for PerAF. Enrolled subjects will be randomized by the ratio of 1:1 into PVI and linear ablation arm or PVI alone arm. Subjects in PVI and linear ablation arm will undergo bilateral PVI, and linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device and EIVOM could be performed additionally before or after PFA at the operator's discretion, it is recommended to perform EIVOM first. Subjects randomized to the PVI alone arm will undergo PVI only. If atrial fibrillation (AF) cannot be terminated during ablation, cardioversion will be performed. After ablation, all the subjects will be followed at discharge, 1 month and then at 3-month intervals up to 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study is a prospective, multicenter, open-label, randomized controlled trial to investigate whether a linear ablation in addition to pulmonary vein isolation (PVI) outperforms PVI alone using pulsed field ablation (PFA) in maintaining sinus rhythm for persistent atrial fibrillation (PerAF)
| Arm | Type | Receives |
|---|---|---|
| PVI and linear ablation arm | Experimental | Procedure: Linear ablation, Procedure: PVI aloneSubjects in PVI and linear ablation arm will undergo bilateral PVI, and linear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device, and EIVOM could be performed additionally before or after PFA at the operator's discretion. |
| PVI alone arm | Active comparator | Procedure: PVI aloneSubjects randomized to the PVI alone arm will undergo PVI only with the study device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with an age range of 18 years or above and 80 years or below.
- Subjects have symptomatic, drug-resistant, persistent AF, defined as:
- Subjects undergoing a first-time ablation procedure for AF.
- Subjects who are willing and capable of providing ICF and participating in all testing associated with this study.
Key exclusion criteria (16 listed)
- AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
- Left atrial anteroposterior diameter ≥ 6.0 cm by transthoracic echocardiography (TTE) within 3 months prior the procedure.
- Heart failure with left ventricular ejection fraction (LVEF) < 30% by TTE within 3 months prior the procedure.
- LA thrombus detected by Transesophageal Echocardiography (TEE) or cardiac CT within one day before the procedure or Intracardiac Echocardiography (ICE) before atrial septal puncture during the procedure.
- Current or anticipated pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices, mechanical valve, interatrial baffle, closure device, patch, or patent foramen oval occlude, left atrial appendage closure at the time of ablation.
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 |
|---|---|---|
| Linear ablationLinear ablations in the posterior wall (PW), mitral isthmus (MI) and cavo-tricuspid isthmus (CTI) using the study device.EIVOM could be performed additionally before or after PFA at the operator's discretion. | Procedure or surgery | PVI and linear ablation arm |
| PVI aloneUndergo PVI with the study device | Procedure or surgery | PVI alone arm, PVI and linear ablation arm |
Primary outcome
Primary Effectiveness Endpoint with Treatment Success.
Time frame: Completion of treatment 360 days compared with the baseline
Number of Participants free from Arrhythmia, Re-ablation, Cardioversion, and AAD use.
Primary Safety Endpoint with Safety events related to AF catheter ablation.
Time frame: Completion of treatment 360 days compared with the baseline
Number of Participants with following device or procedure-related serious Composite Adverse Events (CAEs).
2 secondary outcomes
Secondary Effectiveness Endpoint with Chronic Success.
Time frame: Completion of treatment 360 days compared with the baseline.
Secondary Safety Endpoint with Non-SAE.
Time frame: Completion of treatment 360 days compared with the baseline
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 26 Oct 2026.
- 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.
Changsheng Ma, Doctor principal investigator
Beijing Anzhen Hospital of the Capital University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linear ablation and PVI alone in people with Persistent Atrial Fibrillation, run by Boston Scientific Corporation 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 8 inclusion and 16 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 26 Oct 2026. 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. 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 Taimin Yue (86-10-8574 2988, taimin.yue@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint with Treatment Success. (time frame: Completion of treatment 360 days compared with the baseline). The study lists 2 primary outcomes in all. 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 26 Oct 2026.