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A Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.

12. mai 2026 oppdatert av: Hangzhou Dinova EP Technology Co., Ltd

Prospective, Multicenter, Randomized Controlled Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.

This prospective, multicenter, randomized controlled study was designed to investigate the feasibility, efficacy and safety of pulsed field ablation (PFA) strategies for persistent atrial fibrillation. For patients with persistent atrial fibrillation and normal left atrial substrate, pulmonary vein isolation combined with superior vena cava isolation will be performed. For those with abnormal left atrial substrate, two strategies will be adopted: pulmonary vein isolation plus superior vena cava isolation, and pulmonary vein isolation combined with superior vena cava isolation and left atrial posterior wall isolation. Long-term follow-up will be conducted to observe the long-term clinical outcomes.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

No other detailed description.

Studietype

Intervensjonell

Registrering (Antatt)

350

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: GUODONG NIU
  • Telefonnummer: +86 0871-68279999
  • E-post: guodniu@163.com

Studiesteder

  • Kina
    • Yunnan
      • Kunming, Yunnan, Kina
        • Fuwai Yunnan Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Older than 18 years.
  2. Diagnosed as persistent atrial fibrillation (AF); Definition: At least one episode of persistent AF was recorded on dynamic electrocardiogram (ECG) data within 12 months prior to enrollment, or other clinical evidence supporting persistent AF episodes lasting more than 7 days.
  3. Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.

Exclusion Criteria:

  1. Atrial fibrillation is secondary to thyroid disease or other reversible factors.
  2. Evidence of left atrial or left atrial appendage thrombus on imaging examination.
  3. Rheumatic heart disease or the presence of moderate to severe mitral stenosis or regurgitation.
  4. Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.
  5. Left atrial anteroposterior diameter >55 mm.
  6. Unstable angina.
  7. Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.
  8. Previous catheter ablation or surgical ablation for atrial fibrillation.
  9. History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery.
  10. Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings.
  11. Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation.
  12. Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding.
  13. Active systemic infection.
  14. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or history of renal dialysis.
  15. Severe hepatic dysfunction.
  16. Pregnancy or breastfeeding.
  17. Life expectancy <12 months (e.g., advanced malignancy).
  18. Current or anticipated participation in other drug or device clinical trials.
  19. Any other condition or abnormality deemed by the investigator to warrant exclusion.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: superior vena cava isolation
Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation and left atrial posterior wall isolation will be conducted in the experimental group.
Fremgangsmåte: superior vena cava isolation
Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation isolation will be conducted in the experimental group.
Aktiv komparator: superior vena cava and left atrial posterior wall isolation
Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava and left atrial posterior wall isolation will be carried out in the control group.
Fremgangsmåte: superior vena cava isolation
Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation isolation will be conducted in the experimental group.
Fremgangsmåte: Abnormal left atrial substrate
Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation will be carried out in the control group.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
12-måneders atrieflimmer (AF) ablasjonssuksessrate
Tidsramme: 12 måneder etter prosedyre
Definert som fravær av AF, atrial fladder (AFL) eller atrial takykardi (AT) -episoder ≥30 sekunder på dynamisk elektrokardiogram (EKG) overvåking etter blankingsperioden (90 dager etter kateterablasjon)
12 måneder etter prosedyre

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Acute pulmonary vein ablation success rate and superior vena cava isolation rate.
Tidsramme: Immediately post-procedure
Twenty minutes after completion of ablation, under three-dimensional electroanatomical mapping, the ablated area presents as an electrically silent region (voltage < 0.1 mV). Alternatively, a circular mapping catheter or ablation catheter is positioned within the ablation line: (1) disappearance of intracatheter potentials within the ablation line (entrance block); (2) no local potential capture during pacing of the pulmonary veins and superior vena cava, or local potential capture without subsequent conduction exit (exit block).
Immediately post-procedure
Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only)
Tidsramme: Immediately post-procedure
Twenty minutes after completion of ablation, the ablated area presented as an electrically silent zone (voltage < 0.1 mV) under three-dimensional electroanatomic mapping; no local potential capture was achieved during posterior wall pacing.
Immediately post-procedure
Procedure-related time
Tidsramme: Immediately post-procedure
Total procedure time, catheter manipulation time, pulse discharge time, total fluoroscopy time.
Immediately post-procedure
Early recurrence rate of atrial arrhythmia (within the blanking period)
Tidsramme: Within 3 months post-procedure
Early recurrence rate of atrial arrhythmia (within the blanking period)
Within 3 months post-procedure
Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period.
Tidsramme: Within 12 months post-procedure
Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period
Within 12 months post-procedure
Incidence of repeat ablation after the blanking period
Tidsramme: Within 12 months post-procedure
Incidence of repeat ablation after the blanking period
Within 12 months post-procedure
Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.
Tidsramme: Within 12 months post-fist procedure.
Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation.
Within 12 months post-fist procedure.
Improvement in Atrial fibrillation burden.
Tidsramme: 3、6 and 12 months post-procedure.
Evaluate the improvement in postoperative atrial fibrillation burden via ambulatory electrocardiography.
3、6 and 12 months post-procedure.
Cardiac function assessment by NYHA
Tidsramme: within 12 months post-procedure
Cardiac function was assessed relative to baseline using the NYHA classification.
within 12 months post-procedure
The postoperative quality of life was assessed using the Atrial Fibrillation-Specific Quality of Life Scale.
Tidsramme: Within 12 months post-procedure
Assess the improvement in health-related quality of life after atrial fibrillation surgery using the Atrial Fibrillation Effect on QualiTy of Life score.
Within 12 months post-procedure

Samarbeidspartnere og etterforskere

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Sponsor

Hangzhou Dinova EP Technology Co., Ltd

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. april 2026

Primær fullføring (Antatt)

1. februar 2029

Studiet fullført (Antatt)

1. februar 2029

Datoer for studieregistrering

Først innsendt

20. april 2026

Først innsendt som oppfylte QC-kriteriene

12. mai 2026

Først lagt ut (Faktiske)

15. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EP-CP-IIS-010

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

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Nei

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