Unipolar Voltage Mapping for Personalized Atrial Fibrillation Ablation (UNIQS-AF)
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.
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: AIJU TIAN
- Telefoonnummer: +8618811592092
- E-mail: taj2015@163.com
Studie Locaties
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100037
- Werving
- Fuwai Hospital
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Contact:
- Jiaju Li
- Telefoonnummer: +8618236955005
- E-mail: jiajv_li@163.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: QS-Guided Ablation Group
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.
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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.
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Ander: Conventional PVI Group
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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Freedom from Atrial Fibrillation Recurrence at 3 Months Post Ablation
Tijdsspanne: 3 months (from month 1 to month 6 post-ablation)
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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.
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3 months (from month 1 to month 6 post-ablation)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Total ablation time
Tijdsspanne: Intraoperative (on the day of the ablation procedure)
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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.
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Intraoperative (on the day of the ablation procedure)
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026-3076
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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