Atrial Fibrillation (AF)UNIQS-AFNCT07630857
Unipolar Voltage Mapping for Personalized Atrial Fibrillation Ablation
A study testing Unipolar QS-Potential Guided Catheter Ablation and Conventional Pulmonary Vein Isolation in people with Atrial Fibrillation (AF), run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Atrial fibrillation (AF) is a common heart rhythm disorder. While catheter ablation is an effective treatment, many patients still experience AF recurrence after the procedure. One major reason is that the mechanisms that maintain AF are not fully understood. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Unipolar QS-Potential Guided Catheter Ablation and Conventional Pulmonary Vein Isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2026to 20 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 80 years
- Documented diagnosis of atrial fibrillation (paroxysmal or persistent)
- Planned to undergo catheter ablation for AF (including patients with recurrent AF after prior ablation)
- Able and willing to provide written informed consent
- Able to complete scheduled follow-up visits (3 months post-ablation)
Who cannot join
- Left ventricular ejection fraction < 35%
- Severe valvular heart disease (moderate to severe mitral stenosis or regurgitation)
- History of intracardiac thrombus
- Contraindication to anticoagulation
- Active infection or sepsis
- Pregnancy or breastfeeding
- Life expectancy < 12 months due to comorbid conditions
- Participation in another interventional clinical trial within 30 days prior to enrollment
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
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Jiaju Li, +8618236955005, jiajv_li@163.com
About this study
Official title: Unipolar Mapping for Personalized Atrial Fibrillation Ablation: An Interventional Study on Arrhythmia Maintenance and Atrial Remodeling
Atrial fibrillation (AF) is a common heart rhythm disorder. While catheter ablation is an effective treatment, many patients still experience AF recurrence after the procedure. One major reason is that the mechanisms that maintain AF are not fully understood. Research suggests that the outer layer of the heart (epicardium) may play an important role in keeping AF going. However, current mapping techniques have limitations in detecting electrical signals from both the inner and outer heart layers.
This study uses a different technique called unipolar voltage mapping, which may more accurately capture electrical signals from both heart layers. Specifically, we focus on a specific type of electrical signal called "QS potential" on unipolar mapping, which reflects breakthrough sites between the inner and outer heart layers.
Read more
In this interventional study, participants with AF undergoing catheter ablation will receive personalized ablation guided by unipolar QS-potential mapping. We aim to:
Explore the relationship between unipolar QS-potentials and AF maintenance and atrial remodeling Evaluate the effectiveness of QS-potential guided personalized AF ablation
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Unipolar QS-Potential Guided Catheter Ablation, Conventional Pulmonary Vein Isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unipolar QS-Potential Guided Catheter AblationProcedure or surgery
Participants in this arm undergo catheter ablation for atrial fibrillation guided by unipolar QS-potential mapping. Intracardiac unipolar voltage mapping is performed to identify QS-potentials, which reflect epicardial-endocardial breakthrough sites. Ablation is delivered to these identified target sites in addition to standard pulmonary vein isolation.
Conventional Pulmonary Vein IsolationProcedure or surgery
Participants in this arm undergo conventional pulmonary vein isolation for atrial fibrillation using standard bipolar voltage mapping. Ablation is performed to achieve electrical isolation of the pulmonary veins, without additional mapping-guided ablation beyond PVI.
| Study group | Role | What they receive |
|---|---|---|
| QS-Guided Ablation Group | Experimental | Participants in this arm undergo catheter ablation for atrial fibrillation guided by unipolar QS-potential mapping. Ablation is delivered to these identified target sites in addition to standard pulmonary vein isolation. Receives: Procedure: Unipolar QS-Potential Guided Catheter Ablation |
| Conventional PVI Group | Other | Participants in this arm undergo conventional pulmonary vein isolation for atrial fibrillation using standard bipolar voltage mapping. Ablation is performed to achieve electrical isolation of the pulmonary veins, without additional mapping-guided ablation beyond PVI. Receives: Procedure: Conventional Pulmonary Vein Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Atrial Fibrillation Recurrence at 3 Months Post Ablation
Freedom from any episode of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) lasting ≥30 seconds, as detected by electrocardiogram (ECG) or 24-hour Holter monitoring, after a 3-month blanking period following the ablation procedure.
Measured: 3 months (from month 1 to month 6 post-ablation)
Secondary outcomes (1)
Total ablation time
Total duration of radiofrequency energy delivery during the ablation procedure, measured in minutes. This includes all ablation applications (both pulmonary vein isolation and additional lesion sets) from the first to the last energy application.
Measured: Intraoperative (on the day of the ablation procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start20 Jun 2026 (estimated)
- Primary completion19 Sep 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
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.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yuhe Jia, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630857
- Sponsor's protocol ID
- 2026-3076
- Acronym
- UNIQS-AF
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unipolar Mapping for Personalized Atrial Fibrillation Ablation: An Interventional Study on Arrhythmia Maintenance and Atrial Remodeling
- ClinicalTrials.gov ID
- NCT07630857
- Acronym / sponsor ID
- UNIQS-AF / 2026-3076
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 19 Sep 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 5 Jun 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.
Atrial fibrillation (AF) is a common heart rhythm disorder. While catheter ablation is an effective treatment, many patients still experience AF recurrence after the procedure. One major reason is that the mechanisms that maintain AF are not fully understood. Research suggests that the outer layer of the heart (epicardium) may play an important role in keeping AF going. However, current mapping techniques have limitations in detecting electrical signals from both the inner and outer heart layers.
This study uses a different technique called unipolar voltage mapping, which may more accurately capture electrical signals from both heart layers. Specifically, we focus on a specific type of electrical signal called "QS potential" on unipolar mapping, which reflects breakthrough sites between the inner and outer heart layers.
In this interventional study, participants with AF undergoing catheter ablation will receive personalized ablation guided by unipolar QS-potential mapping. We aim to:
Explore the relationship between unipolar QS-potentials and AF maintenance and atrial remodeling Evaluate the effectiveness of QS-potential guided personalized AF ablation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QS-Guided Ablation Group | Experimental | Procedure: Unipolar QS-Potential Guided Catheter AblationParticipants in this arm undergo catheter ablation for atrial fibrillation guided by unipolar QS-potential mapping. Ablation is delivered to these identified target sites in addition to standard pulmonary vein isolation. |
| Conventional PVI Group | Other | Procedure: Conventional Pulmonary Vein IsolationParticipants in this arm undergo conventional pulmonary vein isolation for atrial fibrillation using standard bipolar voltage mapping. Ablation is performed to achieve electrical isolation of the pulmonary veins, without additional mapping-guided ablation beyond PVI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years and ≤ 80 years
- Documented diagnosis of atrial fibrillation (paroxysmal or persistent)
- Planned to undergo catheter ablation for AF (including patients with recurrent AF after prior ablation)
- Able and willing to provide written informed consent
- Able to complete scheduled follow-up visits (3 months post-ablation)
Key exclusion criteria (8 listed)
- Left ventricular ejection fraction < 35%
- Severe valvular heart disease (moderate to severe mitral stenosis or regurgitation)
- History of intracardiac thrombus
- Contraindication to anticoagulation
- Active infection or sepsis
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 |
|---|---|---|
| Unipolar QS-Potential Guided Catheter AblationParticipants in this arm undergo catheter ablation for atrial fibrillation guided by unipolar QS-potential mapping. Intracardiac unipolar voltage mapping is performed to identify QS-potentials, which reflect epicardial-endocardial breakthrough sites. Ablation is delivered to these identified target sites in addition to standard pulmonary vein isolation. | Procedure or surgery | QS-Guided Ablation Group |
| Conventional Pulmonary Vein IsolationParticipants in this arm undergo conventional pulmonary vein isolation for atrial fibrillation using standard bipolar voltage mapping. Ablation is performed to achieve electrical isolation of the pulmonary veins, without additional mapping-guided ablation beyond PVI. | Procedure or surgery | Conventional PVI Group |
Primary outcome
Freedom from Atrial Fibrillation Recurrence at 3 Months Post Ablation
Time frame: 3 months (from month 1 to month 6 post-ablation)
Freedom from any episode of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) lasting ≥30 seconds, as detected by electrocardiogram (ECG) or 24-hour Holter monitoring, after a 3-month blanking period following the ablation procedure.
1 secondary outcome
Total ablation time
Time frame: Intraoperative (on the day of the ablation procedure)
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 16 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unipolar QS-Potential Guided Catheter Ablation and Conventional Pulmonary Vein Isolation in people with Atrial Fibrillation (AF), run by China National Center for Cardiovascular Diseases 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 5 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 16 Jun 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 AIJU TIAN (+8618811592092, taj2015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Atrial Fibrillation Recurrence at 3 Months Post Ablation (time frame: 3 months (from month 1 to month 6 post-ablation)). 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 16 Jun 2026.