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Recruiting NCT07630857

Unipolar Voltage Mapping for Personalized Atrial Fibrillation Ablation

No phase Interventional Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Unipolar QS-Potential Guided Catheter Ablation, Conventional Pulmonary Vein Isolation.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Procedure Unipolar QS-Potential Guided Catheter Ablation
    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.
  • Procedure Conventional Pulmonary Vein Isolation
    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 outcome measures

  • Freedom from Atrial Fibrillation Recurrence at 3 Months Post Ablation [Time frame: 3 months (from month 1 to month 6 post-ablation)]
Secondary outcome measures (1)
  • Total ablation time [Time frame: Intraoperative (on the day of the ablation procedure)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Fuwai Hospital — Beijing

Identifiers

NCT: NCT07630857 · 2026-3076

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗