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NCT04153292ClinicalTrials.gov

The ENCIRCLE Trial

SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

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En resumen

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…

De intervención900 participantes buscados68 centros6 países

Categorías

Cardiovascular100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

Resumen

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.

Afecciones

  • Mitral Regurgitation
  • Mitral Valve Insufficiency

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseNo aplicable
AsignaciónNo aleatorizado
Modelo de intervenciónSINGLE_GROUP
Propósito principalTREATMENT
EnmascaramientoNONE (0)
Inscripción900 participantes buscados

Patrocinador y colaboradores

  • Edwards Lifesciences Patrocinador

Grupos e intervenciones

  • 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.

Intervenciones

  • Dispositivo SAPIEN M3 valve and dock

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

Variables de resultado

  1. Variable de resultado principal

    Non-hierarchical composite of death and heart failure rehospitalization

    Number of subjects with death and/or heart failure rehospitalization

    Plazo 1 year

  2. Variable de resultado secundaria

    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.

    Plazo 1 year

  3. Variable de resultado secundaria

    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.

    Plazo 1 year

  4. Variable de resultado secundaria

    Improvement in MR compared to baseline

    Number of subjects with improved MR compared to baseline

    Plazo 1 year

  5. Variable de resultado secundaria

    Decrease in LVEDVi compared to baseline

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

    Plazo 1 year

Fechas

Fecha de inicio12 de noviembre de 2020 (real)
Finalización principal28 de febrero de 2027 (estimada)
Finalización28 de febrero de 2031 (estimada)
Primera publicación6 de noviembre de 2019 (real)
Última actualización25 de febrero de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezfebrero de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

3 centros están en reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Royal Prince Alfred HospitalCamperdownActivo, sin reclutar
The Prince Charles HospitalChermsideQueenslandActivo, sin reclutar

Canada

CentroCiudadEstado o regiónEstado
Laval UniversityQuébecQuebecEn reclutamiento
St. Michael'sTorontoEn reclutamiento
St. PaulsVancouverEn reclutamiento

Israel

CentroCiudadEstado o regiónEstado
Shaare Zedek Medical CenterJerusalemRetirado
Rabin Medical CenterPetah TikvaActivo, sin reclutar
Sheba Medical CenterRamat GanRetirado

Netherlands

CentroCiudadEstado o regiónEstado
Leiden University Medical CenterLeidenActivo, sin reclutar
Rotterdam Erasmus MCRotterdamActivo, sin reclutar

United Kingdom

CentroCiudadEstado o regiónEstado
Saint Thomas HospitalLondonActivo, sin reclutar
Saint Bartholomew's Medical CenterLondonActivo, sin reclutar

United States

CentroCiudadEstado o regiónEstado
Piedmont HealthcareAtlantaGeorgiaActivo, sin reclutar
Emory UniversityAtlantaGeorgiaActivo, sin reclutar
Austin HeartAustinTexasActivo, sin reclutar
Medstar Union Memorial HospitalBaltimoreMarylandActivo, sin reclutar
Our Lady of the Lake Regional Medical CenterBaton RougeLouisianaActivo, sin reclutar
Brigham & Women'sBostonMassachusettsRetirado
Massachusetts General HospitalBostonMassachusettsActivo, sin reclutar
University of BuffaloBuffaloNew YorkActivo, sin reclutar
Novant Health and Vascular InstituteCharlotteNorth CarolinaActivo, sin reclutar
Carolinas Medical CenterCharlotteNorth CarolinaRetirado
Rush University Medical CenterChicagoIllinoisRetirado
The Christ HospitalCincinnatiOhioActivo, sin reclutar
Cleveland Clinic FoundationClevelandOhioActivo, sin reclutar
Mount Carmel East HospitalColumbusOhioActivo, sin reclutar
Delray Medical CenterDelray BeachFloridaRetirado
Henry FordDetroitMichiganActivo, sin reclutar
Cardiac & Vascular Institute FoundationGainesvilleFloridaActivo, sin reclutar
Northshore University Health SystemGlenviewIllinoisActivo, sin reclutar
UT Memorial HermannHoustonTexasActivo, sin reclutar
HCA Houston Healthcare Medical (SCRI)HoustonTexasActivo, sin reclutar
Heart Center HospitalHuntsvilleAlabamaActivo, sin reclutar
St. Vincent Heart Center of IndianaIndianapolisIndianaRetirado
Ascension St. Vincent's HospitalJacksonvilleFloridaActivo, sin reclutar
University of KansasKansas CityKansasActivo, sin reclutar
Saint Luke's Kansas CityKansas CityMissouriActivo, sin reclutar
Scripps HealthLa JollaCaliforniaActivo, sin reclutar
Dartmouth-Hitchcock Medical CenterLebanonNew HampshireActivo, sin reclutar
Good Samaritan HospitalLos AngelesCaliforniaActivo, sin reclutar
Kaiser Sunset LALos AngelesCaliforniaActivo, sin reclutar
Cedars-Sinai Medical CenterLos AngelesCaliforniaActivo, sin reclutar
UC Health Northern Colorado (Medical Center of the Rockies)LovelandColoradoActivo, sin reclutar
University of WisconsinMadisonWisconsinRetirado
UPMC Heart and Vascular InstituteMechanicsburgPennsylvaniaActivo, sin reclutar
Minneapolis HeartMinneapolisMinnesotaRetirado
St. Patrick HospitalMissoulaMontanaRetirado
Morristown Medical CenterMorristownNew JerseyRetirado
Intermountain Medical CenterMurrayUtahActivo, sin reclutar
Naples Community HospitalNaplesFloridaActivo, sin reclutar

En el registro figuran 18 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

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