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NCT Number: NCT07630857

Unipolar Voltage Mapping for Personalized Atrial Fibrillation Ablation

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

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Unipolar QS-Potential Guided Catheter Ablation

Procedure

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 Isolation

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total ablation time

    Time frame: Intraoperative (on the day of the ablation procedure)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

AIJU TIAN

CONTACT

[email protected]

+8618811592092

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Unipolar Mapping for Personalized Atrial Fibrillation Ablation: An Interventional Study on Arrhythmia Maintenance and Atrial Remodeling

Acronym: UNIQS-AF

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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