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NCT04153292ClinicalTrials.gov

The ENCIRCLE Trial

SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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…

התערבותידרושים 900 משתתפים68 אתרים6 מדינות

קטגוריות

לב וכלי דם100%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2019-11-06; recorded start 2020-11-12
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are not randomly assignedAllocation is recorded as non-randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 47 other studies in this databaseCounted from the lead sponsor named in the record (Edwards Lifesciences)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Non-randomised allocation

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 68 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 900 participants (target), run at 68 sites, across 6 countries.

How this score is built
  • Enrolment29/40

    900 participants (target)

  • Site count21/25

    68 sites

  • Country count12/15

    6 countries

  • Planned duration10/10

    Planned over about 125 months

  • Sponsor scale6/10

    Edwards Lifesciences has led 47 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

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.

This is a prospective single-arm, multicenter study.

מצבים רפואיים

  • Mitral Regurgitation
  • Mitral Valve Insufficiency

זכאות

מיןהכול
גילאים18 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבלא רלוונטי
הקצאהלא אקראי
מודל ההתערבותSINGLE_GROUP
מטרה ראשיתTREATMENT
הסתרהNONE (0)
גיוסדרושים 900 משתתפים

נותן חסות ושותפים

  • Edwards Lifesciences נותן חסות

זרועות והתערבויות

  • TMVR - Main CohortEXPERIMENTAL

    Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR).

  • TMVR - Failed TEER RegistryEXPERIMENTAL

    Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.

  • TMVR - MAC RegistryEXPERIMENTAL

    Subjects with mitral annular calcification (MAC) will have TMVR.

התערבויות

  • התקן SAPIEN M3 valve and dock

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

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Non-hierarchical composite of death and heart failure rehospitalization

    Number of subjects with death and/or heart failure rehospitalization

    מסגרת זמן 1 year

  2. מדד תוצאה משני

    Improvement in NYHA functional class compared to baseline

    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.

    מסגרת זמן 1 year

  3. מדד תוצאה משני

    Improvement in KCCQ Overall Score compared to baseline

    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.

    מסגרת זמן 1 year

  4. מדד תוצאה משני

    Improvement in MR compared to baseline

    Number of subjects with improved MR compared to baseline

    מסגרת זמן 1 year

  5. מדד תוצאה משני

    Decrease in LVEDVi compared to baseline

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

    מסגרת זמן 1 year

תאריכים

תאריך התחלה12 בנובמבר 2020 (בפועל)
סיום ראשוני28 בפברואר 2027 (משוער)
סיום28 בפברואר 2031 (משוער)
פורסם לראשונה6 בנובמבר 2019 (בפועל)
עודכן לאחרונה25 בפברואר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהפברואר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

3 אתרים מגייסים

Australia

מתקןעירמדינה או אזורמצב
Royal Prince Alfred HospitalCamperdownפעיל, ללא גיוס
The Prince Charles HospitalChermsideQueenslandפעיל, ללא גיוס

Canada

מתקןעירמדינה או אזורמצב
Laval UniversityQuébecQuebecמגייס
St. Michael'sTorontoמגייס
St. PaulsVancouverמגייס

Israel

מתקןעירמדינה או אזורמצב
Shaare Zedek Medical CenterJerusalemבוטל
Rabin Medical CenterPetah Tikvaפעיל, ללא גיוס
Sheba Medical CenterRamat Ganבוטל

Netherlands

מתקןעירמדינה או אזורמצב
Leiden University Medical CenterLeidenפעיל, ללא גיוס
Rotterdam Erasmus MCRotterdamפעיל, ללא גיוס

United Kingdom

מתקןעירמדינה או אזורמצב
Saint Thomas HospitalLondonפעיל, ללא גיוס
Saint Bartholomew's Medical CenterLondonפעיל, ללא גיוס

United States

מתקןעירמדינה או אזורמצב
Piedmont HealthcareAtlantaGeorgiaפעיל, ללא גיוס
Emory UniversityAtlantaGeorgiaפעיל, ללא גיוס
Austin HeartAustinTexasפעיל, ללא גיוס
Medstar Union Memorial HospitalBaltimoreMarylandפעיל, ללא גיוס
Our Lady of the Lake Regional Medical CenterBaton RougeLouisianaפעיל, ללא גיוס
Brigham & Women'sBostonMassachusettsבוטל
Massachusetts General HospitalBostonMassachusettsפעיל, ללא גיוס
University of BuffaloBuffaloNew Yorkפעיל, ללא גיוס
Novant Health and Vascular InstituteCharlotteNorth Carolinaפעיל, ללא גיוס
Carolinas Medical CenterCharlotteNorth Carolinaבוטל
Rush University Medical CenterChicagoIllinoisבוטל
The Christ HospitalCincinnatiOhioפעיל, ללא גיוס
Cleveland Clinic FoundationClevelandOhioפעיל, ללא גיוס
Mount Carmel East HospitalColumbusOhioפעיל, ללא גיוס
Delray Medical CenterDelray BeachFloridaבוטל
Henry FordDetroitMichiganפעיל, ללא גיוס
Cardiac & Vascular Institute FoundationGainesvilleFloridaפעיל, ללא גיוס
Northshore University Health SystemGlenviewIllinoisפעיל, ללא גיוס
UT Memorial HermannHoustonTexasפעיל, ללא גיוס
HCA Houston Healthcare Medical (SCRI)HoustonTexasפעיל, ללא גיוס
Heart Center HospitalHuntsvilleAlabamaפעיל, ללא גיוס
St. Vincent Heart Center of IndianaIndianapolisIndianaבוטל
Ascension St. Vincent's HospitalJacksonvilleFloridaפעיל, ללא גיוס
University of KansasKansas CityKansasפעיל, ללא גיוס
Saint Luke's Kansas CityKansas CityMissouriפעיל, ללא גיוס
Scripps HealthLa JollaCaliforniaפעיל, ללא גיוס
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshireפעיל, ללא גיוס
Good Samaritan HospitalLos AngelesCaliforniaפעיל, ללא גיוס
Kaiser Sunset LALos AngelesCaliforniaפעיל, ללא גיוס
Cedars-Sinai Medical CenterLos AngelesCaliforniaפעיל, ללא גיוס
UC Health Northern Colorado (Medical Center of the Rockies)LovelandColoradoפעיל, ללא גיוס
University of WisconsinMadisonWisconsinבוטל
UPMC Heart and Vascular InstituteMechanicsburgPennsylvaniaפעיל, ללא גיוס
Minneapolis HeartMinneapolisMinnesotaבוטל
St. Patrick HospitalMissoulaMontanaבוטל
Morristown Medical CenterMorristownNew Jerseyבוטל
Intermountain Medical CenterMurrayUtahפעיל, ללא גיוס
Naples Community HospitalNaplesFloridaפעיל, ללא גיוס

18 אתרים נוספים מצוינים ברשומת המרשם.

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT04153292