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Unipolar Voltage Mapping for Personalized Atrial Fibrillation Ablation (UNIQS-AF)

2. juni 2026 opdateret af: Yuhe Jia, China National Center for Cardiovascular Diseases

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100037
        • Rekruttering
        • Fuwai Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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.
Andet: 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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Freedom from Atrial Fibrillation Recurrence at 3 Months Post Ablation
Tidsramme: 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.
3 months (from month 1 to month 6 post-ablation)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total ablation time
Tidsramme: 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.
Intraoperative (on the day of the ablation procedure)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

China National Center for Cardiovascular Diseases

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. juni 2026

Primær færdiggørelse (Anslået)

19. september 2026

Studieafslutning (Anslået)

20. december 2026

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-3076

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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