Atrial Fibrillation (AF)VoS-PVINCT07354737
Efficacy and Safety of a Voltage-Guided Stepwise Strategy for Pulmonary Vein Isolation
A study testing Radiofrequency ablation catheter system in people with Atrial Fibrillation (AF) and Atrial Fibrillation Ablation Procedure, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to learn if a voltage-guided stepwise pulmonary vein isolation (PVI) strategy can achieve effective PVI while potentially reducing lesion delivery, compared with conventional circumferential antral PVI, in adults (≥20 years) with paroxysmal or non-paroxysmal atrial fibrillation… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Fibrillation Ablation Procedure, Atrial Tachyarrhythmia Recurrence
- What is being tested?
- Radiofrequency ablation catheter system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2021to 22 Jan 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥20 years
- Symptomatic paroxysmal or non-paroxysmal atrial fibrillation
- Scheduled for first-time catheter ablation with pulmonary vein isolation
- Able to provide written informed consent
Who cannot join
- Prior catheter or surgical ablation for atrial arrhythmia
- Myocardial infarction within the past 3 months
- Stroke or transient ischemic attack within the past 6 months
- New York Heart Association (NYHA) class III-IV heart failure
- Contraindication to oral anticoagulation
- Pregnancy
- Any medical condition judged by the investigator to make participation unsafe or to interfere with study procedures or follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of a Voltage-Guided Stepwise Strategy for Pulmonary Vein Isolation: A Randomized Comparison With Conventional Circumferential Antral Pulmonary Vein Isolation
The goal of this clinical trial is to learn if a voltage-guided stepwise pulmonary vein isolation (PVI) strategy can achieve effective PVI while potentially reducing lesion delivery, compared with conventional circumferential antral PVI, in adults (≥20 years) with paroxysmal or non-paroxysmal atrial fibrillation undergoing first-time catheter ablation. The main question(s) it aims to answer is/are:
Is voltage-guided stepwise PVI non-inferior to conventional circumferential antral PVI for atrial tachyarrhythmia recurrence within 12 months after ablation?
Read more
Does voltage-guided stepwise PVI differ from conventional circumferential antral PVI in procedural characteristics and safety outcomes, including endoscopically detected esophageal thermal injury and acute procedural complications?
Researchers will compare the voltage-guided stepwise PVI arm to the conventional circumferential antral PVI arm to see if the stepwise approach maintains arrhythmia outcomes while changing lesion delivery requirements and safety outcomes.
Participants will:
Be randomized 1:1 to undergo catheter ablation with either voltage-guided stepwise PVI or conventional circumferential antral PVI.
Undergo diagnostic esophagoscopy between post-procedure day 1 and day 3 to systematically assess for esophageal thermal injury.
Complete follow-up evaluations at 3, 6, 9, and 12 months (and every 6 months thereafter), including 12-lead ECGs and 24- or 72-hour Holter monitoring.
Read the detailed description
Atrial fibrillation (AF) catheter ablation is commonly performed using pulmonary vein isolation (PVI). Conventional PVI is achieved by creating a continuous circumferential antral lesion set, but this may require extensive lesion delivery on the posterior left atrium where the esophagus is adjacent. Voltage mapping can characterize regional atrial signal amplitude, and a stepwise strategy that prioritizes higher-voltage sites along a planned antral path may reduce unnecessary lesion delivery while still achieving acute isolation. This randomized trial compares a voltage-guided stepwise PVI strategy with a conventional circumferential antral PVI strategy in patients undergoing first-time AF ablation.
Participants are randomized 1:1 to one of two PVI strategies. All procedures are performed using a standardized workflow for left atrial mapping and PVI verification. Acute PVI is confirmed by elimination or dissociation of pulmonary vein potentials. Durability of isolation is assessed during the index procedure using adenosine testing for dormant conduction, and trigger provocation is performed per protocol. If isolation is incomplete, additional ablation guided by residual electrical potentials is permitted in both groups to achieve the procedural endpoint.
In the voltage-guided stepwise PVI group, ablation is delivered point-by-point along a predefined antral line using a prespecified stepwise algorithm. Lesion delivery is initiated at sites meeting a high bipolar voltage threshold and expanded stepwise to include progressively lower-voltage sites only as needed until PVI is achieved. If isolation cannot be achieved at the minimum voltage threshold, previously ablated points may be connected to complete a continuous line, and adjunctive ablation (e.g., carina or residual potential-guided ablation) may be performed when necessary.
In the conventional circumferential antral PVI group, operators create a continuous circumferential antral lesion set around the pulmonary veins using the standard approach. Additional potential-guided ablation is allowed when needed to achieve PVI. Voltage information is not used to guide lesion distribution in this group during the procedure.
To systematically assess esophageal safety, diagnostic esophagoscopy is performed between post-procedure day 1 and day 3 in all participants using prespecified criteria for esophageal thermal injury. Follow-up is conducted at scheduled intervals with electrocardiography and ambulatory rhythm monitoring per protocol to document arrhythmia outcomes. A post-ablation blanking period is applied for clinical outcome assessment.
Analyses are performed primarily on an intention-to-treat basis. In addition to the prespecified efficacy and safety comparisons between treatment groups, exploratory analyses evaluate relationships between local voltage characteristics and the voltage threshold required for isolation, including variation by pulmonary vein location and AF phenotype.
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation Ablation Procedure, Atrial Tachyarrhythmia Recurrence, Esophageal Thermal Injury
- Being tested
- Radiofrequency ablation catheter system
- Keywords
- Atrial fibrillation, Catheter ablation, Pulmonary vein isolation, Voltage-guided ablation, High-density voltage mapping, Segmental ablation, Randomized controlled trial, Noninferiority trial
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation catheter systemDevice
Also called Voltage-guided stepwise PVI
Catheter ablation for atrial fibrillation performed using a voltage-guided stepwise PVI strategy. Ablation is delivered point-by-point along a predefined antral line, starting at higher-voltage sites and expanding stepwise to lower-voltage sites only as needed until pulmonary vein isolation is achieved. Additional potential-guided ablation may be performed if required to complete isolation.
Radiofrequency ablation catheter systemDevice
Also called Conventional circumferential antral PVI
Catheter ablation for atrial fibrillation performed using a conventional circumferential antral PVI strategy. A continuous circumferential lesion set is created around the pulmonary vein antrum to achieve isolation. Additional potential-guided ablation may be performed if required to complete isolation.
| Study group | Role | What they receive |
|---|---|---|
| Voltage-guided Stepwise Pulmonary Vein Isolation (PVI) | Experimental | Participants undergo catheter ablation for atrial fibrillation using a voltage-guided stepwise PVI strategy. Ablation is delivered point-by-point along a predefined antral line, starting in higher-voltage regions and expanding stepwise to lower-voltage regions only as needed until pulmonary vein isolation is achieved. Additional ablation may be performed if required to complete isolation based on residual electrical signals. Receives: Device: Radiofrequency ablation catheter system |
| Conventional Circumferential Antral Pulmonary Vein Isolation (PVI) | Active comparator | Participants undergo catheter ablation for atrial fibrillation using a conventional circumferential antral PVI strategy. A continuous circumferential lesion set is created around the pulmonary vein antrum to achieve isolation. Additional ablation may be performed if required to complete isolation based on residual electrical signals. Receives: Device: Radiofrequency ablation catheter system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial tachyarrhythmia recurrence within 12 months after the index ablation
Recurrence of atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) within 12 months after the index ablation, defined as an episode documented on a 12-lead ECG or lasting ≥30 seconds on ambulatory monitoring (24-72-hour Holter). Events occurring during the 3-month post-ablation blanking period are excluded.
Measured: 12 months after the index ablation (excluding a 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 posted21 Jan 2026
- Study start1 Apr 2021
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Model description
- Participants are randomized 1:1 to one of two pulmonary vein isolation strategies (voltage-guided stepwise PVI vs conventional circumferential antral PVI) and followed in parallel for 12-month atrial tachyarrhythmia recurrence and safety outcomes.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwang-No Lee, Ajou University School of Medicine
- Investigators
- Kwang-No Lee, MD, PhD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354737
- Sponsor's protocol ID
- AJIRB-MED-INT-20-475
- Acronym
- VoS-PVI
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in publications from this trial, along with the data dictionary, will be made available to qualified researchers upon reasonable request. Requests must include a brief research proposal and analysis plan and will be reviewed by the study team for scientific merit, feasibility, and protection of participant privacy. Access will require execution of a data use agreement and, when applicable, institutional ethics approval. Shared data will be limited to the minimum necessary and will exclude direct identifiers; recipients must agree not to attempt re-identification or onward sharing without permission.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Voltage-Guided Stepwise Strategy for Pulmonary Vein Isolation: A Randomized Comparison With Conventional Circumferential Antral Pulmonary Vein Isolation
- ClinicalTrials.gov ID
- NCT07354737
- Acronym / sponsor ID
- VoS-PVI / AJIRB-MED-INT-20-475
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation Ablation Procedure, Atrial Tachyarrhythmia Recurrence, Esophageal Thermal Injury
- Keywords
- Atrial fibrillation, Catheter ablation, Pulmonary vein isolation, Voltage-guided ablation, High-density voltage mapping, Segmental ablation, Randomized controlled trial, Noninferiority trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 21 Jan 2026 (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 goal of this clinical trial is to learn if a voltage-guided stepwise pulmonary vein isolation (PVI) strategy can achieve effective PVI while potentially reducing lesion delivery, compared with conventional circumferential antral PVI, in adults (≥20 years) with paroxysmal or non-paroxysmal atrial fibrillation undergoing first-time catheter ablation. The main question(s) it aims to answer is/are:
Is voltage-guided stepwise PVI non-inferior to conventional circumferential antral PVI for atrial tachyarrhythmia recurrence within 12 months after ablation?
Does voltage-guided stepwise PVI differ from conventional circumferential antral PVI in procedural characteristics and safety outcomes, including endoscopically detected esophageal thermal injury and acute procedural complications?
Researchers will compare the voltage-guided stepwise PVI arm to the conventional circumferential antral PVI arm to see if the stepwise approach maintains arrhythmia outcomes while changing lesion delivery requirements and safety outcomes.
Participants will:
Be randomized 1:1 to undergo catheter ablation with either voltage-guided stepwise PVI or conventional circumferential antral PVI.
Undergo diagnostic esophagoscopy between post-procedure day 1 and day 3 to systematically assess for esophageal thermal injury.
Complete follow-up evaluations at 3, 6, 9, and 12 months (and every 6 months thereafter), including 12-lead ECGs and 24- or 72-hour Holter monitoring.
Detailed description
Atrial fibrillation (AF) catheter ablation is commonly performed using pulmonary vein isolation (PVI). Conventional PVI is achieved by creating a continuous circumferential antral lesion set, but this may require extensive lesion delivery on the posterior left atrium where the esophagus is adjacent. Voltage mapping can characterize regional atrial signal amplitude, and a stepwise strategy that prioritizes higher-voltage sites along a planned antral path may reduce unnecessary lesion delivery while still achieving acute isolation. This randomized trial compares a voltage-guided stepwise PVI strategy with a conventional circumferential antral PVI strategy in patients undergoing first-time AF ablation.
Participants are randomized 1:1 to one of two PVI strategies. All procedures are performed using a standardized workflow for left atrial mapping and PVI verification. Acute PVI is confirmed by elimination or dissociation of pulmonary vein potentials. Durability of isolation is assessed during the index procedure using adenosine testing for dormant conduction, and trigger provocation is performed per protocol. If isolation is incomplete, additional ablation guided by residual electrical potentials is permitted in both groups to achieve the procedural endpoint.
In the voltage-guided stepwise PVI group, ablation is delivered point-by-point along a predefined antral line using a prespecified stepwise algorithm. Lesion delivery is initiated at sites meeting a high bipolar voltage threshold and expanded stepwise to include progressively lower-voltage sites only as needed until PVI is achieved. If isolation cannot be achieved at the minimum voltage threshold, previously ablated points may be connected to complete a continuous line, and adjunctive ablation (e.g., carina or residual potential-guided ablation) may be performed when necessary.
In the conventional circumferential antral PVI group, operators create a continuous circumferential antral lesion set around the pulmonary veins using the standard approach. Additional potential-guided ablation is allowed when needed to achieve PVI. Voltage information is not used to guide lesion distribution in this group during the procedure.
To systematically assess esophageal safety, diagnostic esophagoscopy is performed between post-procedure day 1 and day 3 in all participants using prespecified criteria for esophageal thermal injury. Follow-up is conducted at scheduled intervals with electrocardiography and ambulatory rhythm monitoring per protocol to document arrhythmia outcomes. A post-ablation blanking period is applied for clinical outcome assessment.
Analyses are performed primarily on an intention-to-treat basis. In addition to the prespecified efficacy and safety comparisons between treatment groups, exploratory analyses evaluate relationships between local voltage characteristics and the voltage threshold required for isolation, including variation by pulmonary vein location and AF phenotype.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to one of two pulmonary vein isolation strategies (voltage-guided stepwise PVI vs conventional circumferential antral PVI) and followed in parallel for 12-month atrial tachyarrhythmia recurrence and safety outcomes.
| Arm | Type | Receives |
|---|---|---|
| Voltage-guided Stepwise Pulmonary Vein Isolation (PVI) | Experimental | Device: Radiofrequency ablation catheter systemParticipants undergo catheter ablation for atrial fibrillation using a voltage-guided stepwise PVI strategy. Ablation is delivered point-by-point along a predefined antral line, starting in higher-voltage regions and expanding stepwise to lower-voltage regions only as needed until pulmonary vein isolation is achieved. Additional ablation may be performed if required to complete isolation based on residual electrical signals. |
| Conventional Circumferential Antral Pulmonary Vein Isolation (PVI) | Active comparator | Device: Radiofrequency ablation catheter systemParticipants undergo catheter ablation for atrial fibrillation using a conventional circumferential antral PVI strategy. A continuous circumferential lesion set is created around the pulmonary vein antrum to achieve isolation. Additional ablation may be performed if required to complete isolation based on residual electrical signals. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥20 years
- Symptomatic paroxysmal or non-paroxysmal atrial fibrillation
- Scheduled for first-time catheter ablation with pulmonary vein isolation
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- Prior catheter or surgical ablation for atrial arrhythmia
- Myocardial infarction within the past 3 months
- Stroke or transient ischemic attack within the past 6 months
- New York Heart Association (NYHA) class III-IV heart failure
- Contraindication to oral 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 |
|---|---|---|
| Radiofrequency ablation catheter systemAlso: Voltage-guided stepwise PVICatheter ablation for atrial fibrillation performed using a voltage-guided stepwise PVI strategy. Ablation is delivered point-by-point along a predefined antral line, starting at higher-voltage sites and expanding stepwise to lower-voltage sites only as needed until pulmonary vein isolation is achieved. Additional potential-guided ablation may be performed if required to complete isolation. | Device | Voltage-guided Stepwise Pulmonary Vein Isolation (PVI) |
| Radiofrequency ablation catheter systemAlso: Conventional circumferential antral PVICatheter ablation for atrial fibrillation performed using a conventional circumferential antral PVI strategy. A continuous circumferential lesion set is created around the pulmonary vein antrum to achieve isolation. Additional potential-guided ablation may be performed if required to complete isolation. | Device | Conventional Circumferential Antral Pulmonary Vein Isolation (PVI) |
Primary outcome
Atrial tachyarrhythmia recurrence within 12 months after the index ablation
Time frame: 12 months after the index ablation (excluding a 3-month blanking period)
Recurrence of atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) within 12 months after the index ablation, defined as an episode documented on a 12-lead ECG or lasting ≥30 seconds on ambulatory monitoring (24-72-hour Holter). Events occurring during the 3-month post-ablation blanking period are excluded.
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 22 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in publications from this trial, along with the data dictionary, will be made available to qualified researchers upon reasonable request. Requests must include a brief research proposal and analysis plan and will be reviewed by the study team for scientific merit, feasibility, and protection of participant privacy. Access will require execution of a data use agreement and, when applicable, institutional ethics approval. Shared data will be limited to the minimum necessary and will exclude direct identifiers; recipients must agree not to attempt re-identification or onward sharing without permission.
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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.
Kwang-No Lee, MD, PhD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation catheter system in people with Atrial Fibrillation (AF) and Atrial Fibrillation Ablation Procedure, run by Ajou University School of Medicine at 1 site in South Korea.
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: finished, as of the sponsor's last update on 22 Jan 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 South Korea. 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?
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?
Atrial tachyarrhythmia recurrence within 12 months after the index ablation (time frame: 12 months after the index ablation (excluding a 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 22 Jan 2026.