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Tidlig gennemførlighedsundersøgelse - Transkateter atrial shuntsystem (ALT-FLOW US)

29. september 2026 opdateret af: Edwards Lifesciences

Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW US)

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The early feasibility study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • La Jolla, California, Forenede Stater, 92037
        • Aktiv, ikke rekrutterende
        • UC San Diego Health
      • Los Angeles, California, Forenede Stater, 90048
        • Trukket tilbage
        • Cedars Sinai Medical Center
      • San Francisco, California, Forenede Stater, 94143
        • Aktiv, ikke rekrutterende
        • University California San Francisco
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Trukket tilbage
        • University of Colorado
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32209
        • Aktiv, ikke rekrutterende
        • University of Florida Health - Jacksonville
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46260
        • Afsluttet
        • St. Vincent Medical Group
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Aktiv, ikke rekrutterende
        • Kansas University Medical Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Aktiv, ikke rekrutterende
        • Abbott Northwestern
      • Rochester, Minnesota, Forenede Stater, 55905
        • Aktiv, ikke rekrutterende
        • Mayo Clinic
    • New Jersey
      • Morristown, New Jersey, Forenede Stater, 07960
        • Trukket tilbage
        • Morristown Medical Center
    • New York
      • The Bronx, New York, Forenede Stater, 10467
        • Aktiv, ikke rekrutterende
        • Montefiore Medical Center
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Afsluttet
        • Atrium Health
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Aktiv, ikke rekrutterende
        • The Christ Hospital
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • The Ohio State University Medical Center
        • Ledende efterforsker:
          • Scott Lilly, MD
        • Kontakt:
        • Ledende efterforsker:
          • Rami Kahwash, MD
        • Kontakt:
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Rekruttering
        • Oklahoma Heart Institute
        • Ledende efterforsker:
          • Kamran Muhammad, MD
        • Kontakt:
        • Ledende efterforsker:
          • Steven Stroud, MD
        • Kontakt:
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Aktiv, ikke rekrutterende
        • Oregon Health and Science University
    • Pennsylvania
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • Afsluttet
        • Lankenau Institute for Medical Research
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Aktiv, ikke rekrutterende
        • Medical University of South Carolina
    • Washington
      • Seattle, Washington, Forenede Stater, 98122
        • Aktiv, ikke rekrutterende
        • Swedish Medical Center

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Refined HFrEF Subgroup Inclusion Criteria:

  • A primary diagnosis of HFrEF (LVEF ≤ 40%), and

  • NYHA Class II, III, or IVa heart failure symptoms and

  • Documentation of at least one of the following in the past 12 months, such as:

    • Hospitalization for heart failure; or
    • Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
    • Elevated heart failure biomarker levels (BNP or NT-proBNP) within the past 6 months.

Note: Participants with NYHA Class II symptoms must have both a recent heart failure worsening event and elevated biomarker levels. Participants with NYHA Class III or IVa symptoms must have either a recent heart failure worsening event or elevated biomarker levels.

  • Stable Optimized GDMT - Maintained 6 months post-implant (includes stable GLP-1 RA)

Refined HFrEF Subgroup Exclusion Criteria:

  • Severe HF defined as one or more of the following:

    • Ambulatory NT-proBNP value >5,000 pg/ml or BNP value >1,600 pg/ml
    • Left ventricular end-diastolic diameter (LVEDD) >8 cm
    • Left ventricular ejection fraction (LVEF) < 20%
    • ACC/AHA Stage D HF or non-ambulatory NYHA Class IV HF
    • Inotropic infusion (continuous or intermittent) within the past 6 months
    • Active listing on the cardiac transplant waiting list

  • More than mild right ventricular dysfunction

  • Valve disease

    • Mitral regurgitation > moderate
    • Mitral stenosis > mild
    • Tricuspid regurgitation > moderate
    • Aortic regurgitation > moderate
    • Aortic stenosis > moderate

  • Body mass index (BMI) ≥45

  • Myocardial infarction and/or any therapeutic invasive, non-valvular cardiac procedure within the past 3 months, or current indication for coronary revascularization

  • Stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolus within the past 6 months

  • Cardiac resynchronization therapy implanted within the past 12 months

  • Renal insufficiency as determined by serum creatinine (sCr) level >2.5 mg/dL or estimated glomerular filtration rate (eGFR) <25 ml/min/1.73 m2

  • Performance of the 6-minute walk test with a distance <100 m or >450 m

  • Active endocarditis or infection requiring intravenous antibiotics within 3 months of scheduled index procedure

  • Presence of one or more of the following resting hemodynamic findings:

    1. Mean pulmonary capillary wedge pressure (PCWP) >35 mmHg
    2. Mean right atrial pressure (RAP) >15 mmHg
    3. Mean PCWP-mean RAP gradient < 5 mmHg
    4. Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)
    5. Cardiac index <1.8 L/min/m2

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: Edwards APTURE transkateter shuntsystem
Enhed: Edwards APTURE transcatheter shunt system

Transcatheter treatment of symptomatic heart failure patients with elevated left atrial pressure.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)
Tidsramme: 30 days

Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.
30 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate at which device is successfully implanted (Device Success)
Tidsramme: Day 0

Device is deployed as intended and the delivery system is successfully removed as intended at the time of the patient's exit from the implant procedure room.
Day 0
Rate at which device is patent and subject is discharged from hospital without the need for additional intervention for the device (Procedural Success)
Tidsramme: 10 days post-op

Device success with evidence of shunt patency and hospital discharge without the need for additional surgical or percutaneous intervention related to the study device including unacceptable Qp/Qs values.
10 days post-op
Rate at which the procedure is successful without major cardiac/cerebrovascular/renal events and re-intervention (Clinical Success)
Tidsramme: 30 days

Procedural success without major adverse cardiac, cerebrovascular, renal events (MACCRE), and re-intervention for study device related complications at 30 days.
30 days
Change in the ratio of systemic blood flow (Qs) to the pulmonary blood flow (Qp), called "Qp/Qs", from Baseline to Follow Up
Tidsramme: 3 months, 6 months

Change in Qp/Qs value from Baseline to Follow Up (3Month, 6Month)
3 months, 6 months
Improvement in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up
Tidsramme: 3 months, 6 months

Improvement in PCWP value from Baseline to Follow Up (3Month, 6Month)
3 months, 6 months
Change in mean systolic & diastolic pulmonary artery pressure (PAP) and change in mean right atrial pressure (RAP) from Baseline to Follow Up
Tidsramme: 3 months, 6 months

Change in PAP and RAP values from Baseline to Follow Up (3Month, 6Month) under the same test conditions (e.g. comparison in the value at rest at baseline, to at rest at follow up; comparison in the value at exercise at baseline, to at exercise at follow up)
3 months, 6 months
Change in Pulmonary Vascular Resistance (PVR) from Baseline to Follow Up
Tidsramme: 3 months, 6 months

Change in PVR value from Baseline to Follow Up (3Month, 6Month) under the same test conditions (e.g. comparison in the value at rest at baseline, to at rest at follow up; comparison in the value at exercise at baseline, to at exercise at follow up)
3 months, 6 months
Change in two parameters related to Tricuspid Annular Plane Excursion (TAPSE) from Baseline to Follow Up
Tidsramme: 3 months, 6 months

Change in two parameters from Baseline to Follow Up (3Month, 6Month): 1. "TAPSE", Tricuspid Annular Plane Excursion 2. "TAPSE/sPAP", Tricuspid Annular Plane Excursion (TAPSE) divided by the systolic pulmonary Artery Pressure (sPAP)
3 months, 6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HFrEF Subgroup Analysis
Tidsramme: 10 days post-op, 30 days, 3 months, 6 months

Data obtained from the refined HFrEF subgroup will be analyzed according to the endpoints defined above, based on measurements available across all follow-up time points.
10 days post-op, 30 days, 3 months, 6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Edwards Lifesciences

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

31. juli 2018

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2032

Datoer for studieregistrering

Først indsendt

12. april 2018

Først indsendt, der opfyldte QC-kriterier

1. maj 2018

Først opslået (Faktiske)

14. maj 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2018-02

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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