Unipolar Voltage Mapping for Personalized Atrial Fibrillation Ablation

NCT07630857 | Recruiting

• 1 other identifier: 2026-3076
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months (from month 1 to month 6 post-ablation)

Secondary Outcomes (1)

• Total ablation time

  Intraoperative (on the day of the ablation procedure)

Study Arms (2)

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.

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.

Procedure: Conventional Pulmonary Vein Isolation

Interventions

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.

QS-Guided Ablation Group

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.

Conventional PVI Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AIJU TIAN

CONTACT

+8618811592092; taj2015@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Cardiology

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): September 19, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)