Paroxysmal Atrial FibrillationBurst-PAFNCT07281898
Burst Stimulation for Paroxysmal Atrial Fibrillation
A study testing Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) and Burst Stimulation in people with Paroxysmal Atrial Fibrillation, run by Zhibing Lu at 3 sites in China.
Trial summary
Atrial fibrillation (AF) is one of the most common cardiac arrhythmias worldwide, associated with high morbidity and mortality rates. Epidemiological studies in China show that the prevalence of AF in individuals aged ≥60 years ranges from 2% to 3%, with rates continuing to rise due to population aging. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) and Burst Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesChina
- Study dates
- 13 Oct 2025to 31 Jul 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
- Ages 18 to 80 years old;
- Documented diagnosis of paroxysmal atrial fibrillation (self-terminating and lasting < 7 days);
- Patients scheduled for initial radiofrequency catheter ablation (RFCA) treatment;
- Able to sign the informed consent form and comply with a minimum of 12 months of follow-up.
Who cannot join
- Presence of organic heart disease (e.g., rheumatic heart disease, severe valvular stenosis or regurgitation, post-valve replacement, or dilated cardiomyopathy);
- Concomitant atrial tachyarrhythmia requiring radiofrequency ablation (including typical atrial flutter and atrial tachycardia);
- Prior history of catheter ablation for any atrial tachyarrhythmia (including atrial fibrillation, atrial flutter, or atrial tachycardia);
- Concomitant hyperthyroidism, active malignant tumor, or other serious illness with a life expectancy of <1 year;
- Contraindications to anticoagulation;
- Inability to discontinue antiarrhythmic drugs for reasons other than atrial fibrillation;
- Pregnant or breastfeeding women.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Zhibing Lu, 027-67812783, luzhibing222@163.com
- Recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441000
Tongjian Zhu, 8615971160197, whuzhutongjian@126.com
- Recruiting
Yichang Central People's Hospital
Yichang, Hubei
Zhuli Guo, 8615271455251, 392170567@qq.com
About this study
Official title: Efficacy of Burst Stimulation-Guided Ablation Strategy in Improving Single-Procedure Outcomes for Paroxysmal Atrial Fibrillation: A Multicenter, Prospective, Randomized Controlled Study
Atrial fibrillation (AF) is one of the most common cardiac arrhythmias worldwide, associated with high morbidity and mortality rates. Epidemiological studies in China show that the prevalence of AF in individuals aged ≥60 years ranges from 2% to 3%, with rates continuing to rise due to population aging. Paroxysmal atrial fibrillation (PAF), if inadequately controlled, tends to progress to persistent AF, significantly increasing the risk of stroke, heart failure, and death. Catheter ablation has become a first-line therapy for drug-refractory PAF, with pulmonary vein isolation (PVI) recognized as the cornerstone procedure. However, multiple prospective studies and meta-analyses indicate that long-term recurrence rates following PVI alone remain as high as 30%-50%. This observation has prompted researchers to investigate the roles of non-pulmonary vein triggers, atrial remodeling, and electrophysiological substrate in PAF recurrence. The superior vena cava (SVC) has been identified as a common non-pulmonary vein trigger, with empirical SVC isolation demonstrating additional clinical benefits in select studies. Furthermore, the presence of atrial electrical remodeling and reentry-dependent substrate suggests that trigger-focused ablation strategies alone may be insufficient to prevent recurrence in certain PAF patients. Burst pacing-induced atrial tachyarrhythmias, such as atrial flutter or fibrillation, provide a practical method for assessing atrial substrate. Retrospective studies indicate that additional linear ablation targeting procedure-induced atrial tachycardias, such as typical atrial flutter, can significantly reduce PAF recurrence rates. However, this strategy currently lacks high-quality evidence from prospective randomized controlled trials.
To date, no large-scale randomized controlled trial (RCT) has systematically validated the impact of programmed burst pacing combined with individualized linear ablation on outcomes in PAF patients, nor have standardized induction protocols or supplementary ablation pathways been established. This study addresses a critical need for optimized treatment strategies in the field of catheter ablation, with significant clinical implications and potential for widespread application.
Therefore, this prospective, multicenter, randomized controlled trial aims to systematically evaluate the efficacy and safety of this strategy in reducing post-ablation PAF recurrence, improving quality of life, and controlling AF burden. The study seeks to fill the current evidence gap and advance AF treatment from standardized protocols toward individualized precision intervention.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI), Burst Stimulation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI)Procedure or surgery
Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI)
Burst StimulationProcedure or surgery
Burst Stimulation + Individualized Linear Ablation
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) + Burst Stimulation + Individualized Linear Ablation Receives: Procedure: Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI); Procedure: Burst Stimulation |
| Control group | Active comparator | Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) Receives: Procedure: Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Measured: 1-, 3-, 6-, 12-month follow-up
Secondary outcomes (3)
The incidence of major adverse cardiovascular events (MACE), bleeding events, and all-cause mortality
Measured: perioperative period and 1-, 3-, 6-, 12-month follow-up
Rate of arrhythmia induction
Measured: intra-procedural
Incidence of complications
Measured: perioperative period and 1-, 3-, 6-, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start13 Oct 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhibing Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhibing Lu, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281898
- Sponsor's protocol ID
- 2025198
- Acronym
- Burst-PAF
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect the privacy of participants, the individual participant data (IPD) from this study will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Burst Stimulation-Guided Ablation Strategy in Improving Single-Procedure Outcomes for Paroxysmal Atrial Fibrillation: A Multicenter, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07281898
- Acronym / sponsor ID
- Burst-PAF / 2025198
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Zhibing LuUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 15 Dec 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.
Atrial fibrillation (AF) is one of the most common cardiac arrhythmias worldwide, associated with high morbidity and mortality rates. Epidemiological studies in China show that the prevalence of AF in individuals aged ≥60 years ranges from 2% to 3%, with rates continuing to rise due to population aging. Paroxysmal atrial fibrillation (PAF), if inadequately controlled, tends to progress to persistent AF, significantly increasing the risk of stroke, heart failure, and death. Catheter ablation has become a first-line therapy for drug-refractory PAF, with pulmonary vein isolation (PVI) recognized as the cornerstone procedure. However, multiple prospective studies and meta-analyses indicate that long-term recurrence rates following PVI alone remain as high as 30%-50%. This observation has prompted researchers to investigate the roles of non-pulmonary vein triggers, atrial remodeling, and electrophysiological substrate in PAF recurrence. The superior vena cava (SVC) has been identified as a common non-pulmonary vein trigger, with empirical SVC isolation demonstrating additional clinical benefits in select studies. Furthermore, the presence of atrial electrical remodeling and reentry-dependent substrate suggests that trigger-focused ablation strategies alone may be insufficient to prevent recurrence in certain PAF patients. Burst pacing-induced atrial tachyarrhythmias, such as atrial flutter or fibrillation, provide a practical method for assessing atrial substrate. Retrospective studies indicate that additional linear ablation targeting procedure-induced atrial tachycardias, such as typical atrial flutter, can significantly reduce PAF recurrence rates. However, this strategy currently lacks high-quality evidence from prospective randomized controlled trials.
To date, no large-scale randomized controlled trial (RCT) has systematically validated the impact of programmed burst pacing combined with individualized linear ablation on outcomes in PAF patients, nor have standardized induction protocols or supplementary ablation pathways been established. This study addresses a critical need for optimized treatment strategies in the field of catheter ablation, with significant clinical implications and potential for widespread application.
Therefore, this prospective, multicenter, randomized controlled trial aims to systematically evaluate the efficacy and safety of this strategy in reducing post-ablation PAF recurrence, improving quality of life, and controlling AF burden. The study seeks to fill the current evidence gap and advance AF treatment from standardized protocols toward individualized precision intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI), Procedure: Burst StimulationPulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) + Burst Stimulation + Individualized Linear Ablation |
| Control group | Active comparator | Procedure: Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI)Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18 to 80 years old;
- Documented diagnosis of paroxysmal atrial fibrillation (self-terminating and lasting < 7 days);
- Patients scheduled for initial radiofrequency catheter ablation (RFCA) treatment;
- Able to sign the informed consent form and comply with a minimum of 12 months of follow-up.
Key exclusion criteria (7 listed)
- Presence of organic heart disease (e.g., rheumatic heart disease, severe valvular stenosis or regurgitation, post-valve replacement, or dilated cardiomyopathy);
- Concomitant atrial tachyarrhythmia requiring radiofrequency ablation (including typical atrial flutter and atrial tachycardia);
- Prior history of catheter ablation for any atrial tachyarrhythmia (including atrial fibrillation, atrial flutter, or atrial tachycardia);
- Concomitant hyperthyroidism, active malignant tumor, or other serious illness with a life expectancy of <1 year;
- Contraindications to anticoagulation;
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 |
|---|---|---|
| Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI)Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) | Procedure or surgery | Control group, Test group |
| Burst StimulationBurst Stimulation + Individualized Linear Ablation | Procedure or surgery | Test group |
Primary outcome
Recurrence rate
Time frame: 1-, 3-, 6-, 12-month follow-up
3 secondary outcomes
The incidence of major adverse cardiovascular events (MACE), bleeding events, and all-cause mortality
Time frame: perioperative period and 1-, 3-, 6-, 12-month follow-up
Rate of arrhythmia induction
Time frame: intra-procedural
Incidence of complications
Time frame: perioperative period and 1-, 3-, 6-, 12-month follow-up
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 15 Dec 2025.
- Individual participant dataSharing planned: No. In order to protect the privacy of participants, the individual participant data (IPD) from this study will not be shared.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) and Burst Stimulation in people with Paroxysmal Atrial Fibrillation, run by Zhibing Lu at 3 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 4 inclusion and 7 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 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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 Zhibing Lu (027-67812783, luzhibing222@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 1-, 3-, 6-, 12-month follow-up). 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 15 Dec 2025.