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

15 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • Bay Shore, New York, Förenta staterna, 11706
        • Rekrytering
        • South Shore University Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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 in women and >=2 in men
  • 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
  • Participant has longstanding persistent AF ongoing for greater than 10 years
  • Participant has Left atrial appendage anatomy unsuitable for LAAO device
  • Participant has an LA diameter >6 cm

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To prospectively assess durability of PFA ablation
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To assess arrhythmia-free survival in patients with confirmed durable PVI (+/-) posterior wall isolation
Tidsram: 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.
Tidsram: 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.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Northwell Health

Samarbetspartners

Boston Scientific Corporation

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2026

Primärt slutförande (Beräknad)

1 maj 2028

Avslutad studie (Beräknad)

1 juli 2028

Studieregistreringsdatum

Först inskickad

18 maj 2026

Först inskickad som uppfyllde QC-kriterierna

27 maj 2026

Första postat (Faktisk)

2 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 juli 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 25-1100

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Ja

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