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ENCIRCLE Trial (ENCIRCLE)

5. oktober 2026 opdateret af: Edwards Lifesciences

SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.

Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective single-arm, multicenter study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

786

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Australien
      • Camperdown, Australien, NSW2050
        • Royal Prince Alfred Hospital
    • Queensland
      • Chermside, Queensland, Australien, 4032
        • The Prince Charles Hospital
  • Canada
      • Toronto, Canada, M5B 1W8
        • St. Michael's
      • Vancouver, Canada, V6E 1M7
        • St. Pauls
    • Quebec
      • Québec, Quebec, Canada, G1V 0A6
        • Laval University
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, EC1A 7BE
        • Saint Bartholomew's Medical Center
      • London, Det Forenede Kongerige, SE1 7EH
        • Saint Thomas Hospital
  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater, 35801
        • Heart Center Hospital
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Banner University Medical Center
      • Phoenix, Arizona, Forenede Stater, 85013
        • Saint Josephs Hospital Medical Center Dignity Health
    • California
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Health
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Forenede Stater, 90017
        • Good Samaritan Hospital
      • Los Angeles, California, Forenede Stater, 90071
        • Kaiser Sunset LA
      • San Francisco, California, Forenede Stater, 94109
        • California Pacific Medical Center
    • Colorado
      • Loveland, Colorado, Forenede Stater, 80538
        • UC Health Northern Colorado (Medical Center of the Rockies)
    • Florida
      • Gainesville, Florida, Forenede Stater, 32605
        • Cardiac & Vascular Institute Foundation
      • Jacksonville, Florida, Forenede Stater, 32204
        • Ascension St. Vincent's Hospital
      • Naples, Florida, Forenede Stater, 34102
        • Naples Community Hospital
      • Sarasota, Florida, Forenede Stater, 34239
        • Sarasota Memorial Hospital
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory University
      • Atlanta, Georgia, Forenede Stater, 30309
        • Piedmont Healthcare
    • Illinois
      • Glenview, Illinois, Forenede Stater, 60026
        • Northshore University Health System
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas
      • Wichita, Kansas, Forenede Stater, 67226
        • Cardiovascular Research Institute of Kansas (CRIOK)
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Our Lady of the Lake Regional Medical Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21218
        • Medstar Union Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • CentraCare
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Kansas City
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • Robert Wood Johnson University Hospital
    • New York
      • Buffalo, New York, Forenede Stater, 14203
        • University of Buffalo
      • New York, New York, Forenede Stater, 10007
        • Weill Cornell Medicine
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Novant Health and Vascular Institute
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • The Christ Hospital
      • Cleveland, Ohio, Forenede Stater, 44122
        • Cleveland Clinic Foundation
      • Columbus, Ohio, Forenede Stater, 43123
        • Mount Carmel East Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Oklahoma Heart Hospital
      • Tulsa, Oklahoma, Forenede Stater, 74104
        • Oklahoma Heart Institute
    • Pennsylvania
      • Mechanicsburg, Pennsylvania, Forenede Stater, 17050
        • UPMC Heart and Vascular Institute
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37205
        • Saint Thomas Health
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Austin Heart
      • Houston, Texas, Forenede Stater, 77030
        • UT Memorial Hermann
      • Houston, Texas, Forenede Stater, 77004
        • HCA Houston Healthcare Medical (SCRI)
    • Utah
      • Murray, Utah, Forenede Stater, 84107
        • Intermountain Medical Center
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Sentara Norfolk
      • Roanoke, Virginia, Forenede Stater, 24014
        • Carilion Roanoke Memorial Hospital
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Seattle
  • Holland
      • Leiden, Holland, 2333 ZA
        • Leiden University Medical Center
      • Rotterdam, Holland, 3015 CE
        • Rotterdam Erasmus MC
  • Israel
      • Petah Tikva, Israel, 4941492
        • Rabin 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

Inclusion Criteria:

  1. 18 years of age or older
  2. MR ≥ 3+
  3. NYHA functional class ≥ II
  4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
  5. Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment.
  6. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

  1. Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve
  2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
  3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
  4. Left ventricular ejection fraction <25%
  5. Severe right ventricular dysfunction
  6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
  7. History of heart transplant
  8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
  9. Active bacterial endocarditis within 180 days of the procedure
  10. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure
  11. Myocardial infarction within 30 days of the procedure
  12. Clinically significant untreated coronary artery disease requiring revascularization
  13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure
  14. Stroke or transient ischemic attack within 90 days of the procedure
  15. Irreversible, severe pulmonary hypertension
  16. Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
  17. Renal insufficiency or receiving renal replacement therapy
  18. Liver disease
  19. Planned surgery within the next 12 months
  20. Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure
  21. Active infection requiring current antibiotic therapy
  22. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
  23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
  24. Refusal of blood products
  25. Female who is pregnant or lactating
  26. Estimated life expectancy <12 months due to non-cardiac conditions
  27. Participating in another investigational drug or device study that has not reached its primary endpoint
  28. Subject considered to be part of a vulnerable population

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: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TMVR - Main Cohort

Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR).
Enhed: SAPIEN M3 valve and dock

During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
Eksperimentel: TMVR - Failed TEER Registry

Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.
Enhed: SAPIEN M3 valve and dock

During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
Eksperimentel: TMVR - MAC Registry

Subjects with mitral annular calcification (MAC) will have TMVR.
Enhed: SAPIEN M3 valve and dock

During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Non-hierarchical composite of death and heart failure rehospitalization
Tidsramme: 1 year

Number of subjects with death and/or heart failure rehospitalization
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in NYHA functional class compared to baseline
Tidsramme: 1 year

New York Heart Association (NYHA) functional classification of heart failure is based on how much a patient is limited during physical activity. The rating ranges from I-IV. I = no limitations of physical activity; II = slight limitations of physical activity, ordinary physical activity results in fatigue, palpitation, shortness of breath; III = marked limitations of physical activity, less than ordinary activity causes fatigue, palpitation, or shortness of breath; IV = unable to carry on any physical activity without discomfort, symptoms of heart failure at rest.
1 year
Improvement in KCCQ Overall Score compared to baseline
Tidsramme: 1 year

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
1 year
Improvement in MR compared to baseline
Tidsramme: 1 year

Number of subjects with improved MR compared to baseline
1 year
Decrease in LVEDVi compared to baseline
Tidsramme: 1 year

Number of subjects with decreased left ventricular end-diastolic volume index (LVEDVi) compared to baseline
1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Edwards Lifesciences

Efterforskere

  • Ledende efterforsker: John Webb, MD, St. Paul's Hospital
  • Ledende efterforsker: Mayra Guerrero, MD, Mayo Clinic
  • Ledende efterforsker: David Daniels, MD, California Pacific Medical Center

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)

12. november 2020

Primær færdiggørelse (Anslået)

10. oktober 2027

Studieafslutning (Anslået)

10. oktober 2031

Datoer for studieregistrering

Først indsendt

4. november 2019

Først indsendt, der opfyldte QC-kriterier

5. november 2019

Først opslået (Faktiske)

6. november 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. oktober 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2018-19

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

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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