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Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study (PRECLUDE)

27. maj 2026 opdateret af: Northwell Health
This is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for the insertion of a left atrial appendage occlusion (LAAO) device. The reassessment of the initial ablation will be performed with or without additional ablation if needed.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Atrial fibrillation is a heart condition where the heart beats rapidly and/or irregularly. An ablation procedure is a form of treatment for atrial fibrillation to try to maintain or return the heart to a normal rhythm (called sinus rhythm). Ablation procedures can be done using heat (radiofrequency energy), cold (cryo energy), or electrical energy emitted by pulses (pulsed field ablation). Pulsed field ablation (PFA) is an invasive treatment procedure for which the doctor will deliver controlled energy through a PFA Catheter to destroy or scar the specific heart tissue causing the abnormal electrical signals. This scar helps to interrupt the abnormal electrical pathways and restore a normal heart rhythm. Ablation procedures are performed according to the standard of care.

The purpose of this study is to research the durability of receiving a PFA for the treatment of atrial fibrillation during a subsequent procedure performed at least 30 days after the initial ablation. The remapping procedure will utilize integrated electroanatomic mapping and intracardiac echocardiography to determine the index procedure technical success independent of arrhythmia recurrence.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • New York
      • Bay Shore, New York, Forenede Stater, 11706
        • Rekruttering
        • South Shore University 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:

  • Participant is ≥ 18 years of age, or older if specified by local law
  • Participant has documented paroxysmal or persistent atrial fibrillation not related to a reversible cause
  • Participant has AF-related symptoms, and/or presence of CHF or LV dysfunction
  • Participant has a CHADSVASc>=3
  • There is appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation for thromboembolic protection
  • Participant is willing and capable of providing informed consent
  • Participant is willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center

Exclusion Criteria:

  • Participant has had prior AF ablation (including surgical ablation)
  • Participant has had prior left atrial appendage occlusion or closure
  • Participant has an intracardiac mass or thrombus
  • Participant has had a bleeding disorder or inability to tolerate short-term oral anticoagulation
  • Participant has a life expectancy < 1 year
  • Participant has had recent MI, CVA, or cardiac surgery in preceding 90 days
  • Participant has an inability to comply with outpatient follow-up, or cognitive impairment that precludes understanding of procedure risks and benefits Participant has an active systemic infection
  • Participant has a mechanical heart valve through which the catheter must pass, or severe mitral stenosis
  • Participant has a vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach
  • Participant had congenital heart disease where the underlying abnormality increases the risk of ablation (e.g. severe rotational anomalies of the heart or great vessels)
  • Participant is woman of childbearing potential who is pregnant, lactating, not using a reliable form of contraception, or who is planning to become pregnant during the anticipated study period

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Single-arm, open label - all enrolled subjects
Remapping procedure with LAAO Implant with or without additional ablation.
Enhed: Remapping Procedure
Remapping procedure with LAAO Implant with or without additional ablation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To prospectively assess durability of PFA ablation
Tidsramme: From Index Ablation to Subsequent Re-mapping procedure with concomitant LAAO implant. The remapping procedure will occur approximately 30-180 days after the index ablation.
Durability analysis will include % of patients with any PV reconnection, % of PVs reconnected, and % of patients with recovered conduction in the endocardial posterior wall (if posterior wall isolation performed at the index procedure).
From Index Ablation to Subsequent Re-mapping procedure with concomitant LAAO implant. The remapping procedure will occur approximately 30-180 days after the index ablation.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess arrhythmia-free survival in patients with confirmed durable PVI (+/-) posterior wall isolation
Tidsramme: 6 months and 12 months post remapping procedure
Patients demonstrating durable PVI (+/- posterior wall isolation) confirmed during remapping procedure will be monitored for arrhythmia recurrence. Arrhythmia recurrence will be evaluated based on 1-week extended Holter monitoring performed at 6 months and 12 months post ablation.
6 months and 12 months post remapping procedure
Assess clinical outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures.
Tidsramme: From enrollment/index ablation to the 12month follow up post remapping procedure
Clinical outcomes following this novel prospective dual-procedure strategy will be analyzed, including assessment of clinical AT/AF recurrence and symptomatic arrhythmia recurrence.
From enrollment/index ablation to the 12month follow up post remapping procedure
Assess procedure related outcomes following strategy of LAAO implant and potential for repeat AF ablation performed as consecutive procedures.
Tidsramme: From enrollment/index ablation to the 12month follow up post remapping procedure
Procedural related outcomes following this novel prospective dual-procedure strategy will be analyzed, including assessment of ischemic stroke/TIA, bleeding complications, hospitalizations, and death.
From enrollment/index ablation to the 12month follow up post remapping procedure

Samarbejdspartnere og efterforskere

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

Sponsor

Northwell Health

Samarbejdspartnere

Boston Scientific Corporation

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 (Faktiske)

1. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-1100

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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Kliniske forsøg med Atrieflimren (AF)

Kliniske forsøg med Remapping Procedure

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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