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Laminær LAAX Pivotal IDE-studie

14. oktober 2026 oppdatert av: Jaguar LAA, Inc.

Laminar venstre atrial appendage-eliminering (LAAX) Pivotal IDE-studie

The purpose of this study is to compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).

Studieoversikt

Status

Suspendert

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).

Studietype

Intervensjonell

Registrering (Antatt)

1500

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35243
        • Grandview Medical Center
    • Arizona
      • Phoenix, Arizona, Forente stater, 85018
        • Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG
      • Tucson, Arizona, Forente stater, 85712
        • Tucson Medical Center
    • Arkansas
      • Jonesboro, Arkansas, Forente stater, 72401
        • Arrhythmia Research Group
    • California
      • Los Angeles, California, Forente stater, 90048
        • Cedars Sinai Medical Center
      • Palo Alto, California, Forente stater, 94303
        • Stanford Health Care
      • Rancho Cordova, California, Forente stater, 95670
        • Univeristy of California Davis Health
      • San Diego, California, Forente stater, 92121
        • Scripps Health
      • Santa Monica, California, Forente stater, 90404
        • Providence Saint John's Health Center and the Pacific Heart Institute
      • Thousand Oaks, California, Forente stater, 91360
        • Los Robles Regional Medical Center
    • Florida
      • North Naples, Florida, Forente stater, 34102
        • NCH Healthcare
      • Sarasota, Florida, Forente stater, 34239
        • Sarasota Memorial Hospital
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory University
      • Atlanta, Georgia, Forente stater, 30309
        • Piedmont Healthcare
      • Savannah, Georgia, Forente stater, 31404
        • Memorial Health University Medical Center
    • Kansas
      • Overland Park, Kansas, Forente stater, 66211
        • The Kansas City Heart Rhythm Institute
      • Wichita, Kansas, Forente stater, 67214
        • Ascension via Christi Hospitals Wichita Inc
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40503
        • Baptist Health Lexington
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital
    • New York
      • Bay Shore, New York, Forente stater, 11706
        • Northwell Health
      • New York, New York, Forente stater, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Forente stater, 10016
        • NYU Langone Health
      • New York, New York, Forente stater, 10032
        • Columbia University in the City of New York and The New York and Presbyterian Hospital
      • The Bronx, New York, Forente stater, 10467
        • Montefiore Medical Center
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28203
        • Wake Forest University Health Sciences
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
        • Lindner Clinical Trial Center/Christ Hospital
      • Cincinnati, Ohio, Forente stater, 45202
        • Bethesda North Hospital Trihealth
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State University
      • Columbus, Ohio, Forente stater, 43214
        • Ohio Health
    • South Carolina
      • North Charleston, South Carolina, Forente stater, 29406
        • Trident Medical Center
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, Forente stater, 37203
        • Centennial Medical Center
    • Texas
      • Austin, Texas, Forente stater, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Shenandoah, Texas, Forente stater, 77380
        • Heart Rhythm Associates
    • Washington
      • Seattle, Washington, Forente stater, 98122
        • Swedish Medical Center
      • Tacoma, Washington, Forente stater, 98405
        • St Joseph Hospital and Medical Center

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF)
  • CHA2DS2-VASc score greater than or equal to (>=) 2 in men and >= 3 in women
  • Deemed to be clinically indicated for left atrial appendage (LAA) closure by the Site Investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care
  • Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative
  • Eligible for the protocol-specified post-procedural antithrombotic regimen
  • Willing and able to comply with the protocol, and has provided written informed consent (participant or legally authorized representative) per institutional review board (IRB) requirements

Exclusion Criteria:

  • Single episode, transient, or reversible atrial fibrillation (AF) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
  • Prior cardiac surgery or any procedure that involved pericardial access
  • Stage IV kidney disease or Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (<) 30 milliliters per minute per (mL/min)/1.73 square meters (m^2) or participants with end stage renal disease who are dialysis dependent
  • Any cardiac or non-cardiac interventional or surgical procedures within 60 days prior to or any planned general surgery, cardiac surgery, or interventional procedure within 60 days after implant (including, but not limited to cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery)
  • Left atrial appendage anatomy which cannot accommodate either commercially available control device or the laminar implant per manufacturer instructions for use (IFU) (that is, the anatomy and sizing must be appropriate for a control and the Laminar device to be enrolled in the study)

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: Laminar Device

Participants will be treated with the Laminar Left Atrial Appendage Closure System.
Enhet: Experimental: Laminar Left Atrial Appendage Closure System

Treatment with the Laminar Left Atrial Appendage Closure System.
Aktiv komparator: Control left atrial appendage closure (LAAC)

Participants will be treated with a commercially-available LAAC device.
Enhet: Active Comparator: WATCHMAN / Amulet

Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All-Cause Mortality
Tidsramme: Up to 12 months

Composite rate of all-cause mortality will be reported.
Up to 12 months
Number of Participants With Major Bleeding According to the Bleeding Academic Research Consortium (BARC) Type III or V
Tidsramme: Up to 12 months

The number of participants with major bleeding, according to the BARC type III or V, will be reported.

Type III

  1. Type IIIa includes overt bleeding plus a hemoglobin drop of 3 to less than (<) 5 grams per deciliter (g/dL) related to bleeding and any transfusion with overt bleeding.
  2. Type IIIb involves overt bleeding plus a hemoglobin drop of greater than or equal to (>=) 5 g/dL related to bleeding, cardiac tamponade, bleeding requiring surgical intervention for control, or bleeding requiring intravenous vasoactive agents.
  3. Type IIIc includes intracranial hemorrhage, with subcategories confirmed by autopsy, imaging, or lumbar puncture, as well as intraocular bleeding compromising vision.

Type V

  1. Type Va: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious.
  2. Type Vb: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation.
Up to 12 months
Number of Participants With Pericardial Effusion Requiring Drainage
Tidsramme: Up to 12 months

Participants with pericardial effusion requiring drainage will be reported. Pericardial effusion is defined as 1) Clinically non-relevant: requiring no intervention, treated pharmacologically and 2) Clinically relevant: treated with therapeutic intervention (pericardiocentesis, surgical intervention, blood transfusion) and/or result in shock or death.
Up to 12 months
Number of Participants With Device Embolization
Tidsramme: Up to 12 months

Participants with device embolization will be reported. Device embolization is defined as movement of a medical device to an unintended location within the body with resulting obstruction of an organ or vessel.
Up to 12 months
Number of Participants With Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Intervention
Tidsramme: Up to 12 Months

Participants with device or procedure-related events requiring open cardiac surgery or major endovascular intervention will be reported.
Up to 12 Months
Number of Participants Reporting Ischemic Stroke or Systemic Embolism
Tidsramme: Up to 18 Months

Participant reporting ischemic stroke or systemic embolism will be reported. Systemic embolism is defined as acute vascular insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (example; trauma, atherosclerosis, or instrumentation).
Up to 18 Months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Peri-Device Flow
Tidsramme: Up to 12 Months

Peri-Device flow is defined as >= 3 mm in width which communicates beyond the device into the body of the left atrial appendage) per transesophageal echocardiogram (TEE) evaluated by independent core laboratory.
Up to 12 Months
Rate of Device-Related Thrombosis
Tidsramme: Up to 12 Months

Device related thrombosis is defined as density attached to the implanted LAAC device in echocardiographic or computer tomography imaging.
Up to 12 Months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Jaguar LAA, Inc.

Etterforskere

  • Hovedetterforsker: Saibal Kar, MD, Los Robles Health System
  • Hovedetterforsker: Devi Nair, MD, St. Bernards Heart and Vascular Center

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 (Faktiske)

19. februar 2024

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

29. februar 2032

Datoer for studieregistrering

Først innsendt

5. desember 2023

Først innsendt som oppfylte QC-kriteriene

5. desember 2023

Først lagt ut (Faktiske)

13. desember 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LAM202403
  • CL-0059 (Annen identifikator: Laminar, Inc.)
  • LAM202403 (Annen identifikator: Biosense Webster, Inc.)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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