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NCT04153292ClinicalTrials.gov

The ENCIRCLE Trial

SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Interventionnelle900 participants recherchés68 sites6 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

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Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

  • Mitral Regurgitation
  • Mitral Valve Insufficiency

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhaseSans objet
RépartitionNon randomisée
Modèle d'interventionSINGLE_GROUP
Objectif principalTREATMENT
InsuNONE (0)
Recrutement900 participants recherchés

Promoteur et collaborateurs

  • Edwards Lifesciences Promoteur

Groupes et interventions

  • 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.

Interventions

  • Dispositif SAPIEN M3 valve and dock

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

Critères de jugement

  1. Critère de jugement principal

    Non-hierarchical composite of death and heart failure rehospitalization

    Number of subjects with death and/or heart failure rehospitalization

    Délai 1 year

  2. Critère de jugement secondaire

    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.

    Délai 1 year

  3. Critère de jugement secondaire

    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.

    Délai 1 year

  4. Critère de jugement secondaire

    Improvement in MR compared to baseline

    Number of subjects with improved MR compared to baseline

    Délai 1 year

  5. Critère de jugement secondaire

    Decrease in LVEDVi compared to baseline

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

    Délai 1 year

Dates

Date de début12 novembre 2020 (réelle)
Achèvement principal28 février 2027 (estimée)
Achèvement28 février 2031 (estimée)
Première publication6 novembre 2019 (réelle)
Dernière mise à jour25 février 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisfévrier 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

3 sites sont en recrutement

Australia

ÉtablissementVilleÉtat ou régionStatut
Royal Prince Alfred HospitalCamperdownActif, sans recrutement
The Prince Charles HospitalChermsideQueenslandActif, sans recrutement

Canada

ÉtablissementVilleÉtat ou régionStatut
Laval UniversityQuébecQuebecEn recrutement
St. Michael'sTorontoEn recrutement
St. PaulsVancouverEn recrutement

Israel

ÉtablissementVilleÉtat ou régionStatut
Shaare Zedek Medical CenterJerusalemRetiré
Rabin Medical CenterPetah TikvaActif, sans recrutement
Sheba Medical CenterRamat GanRetiré

Netherlands

ÉtablissementVilleÉtat ou régionStatut
Leiden University Medical CenterLeidenActif, sans recrutement
Rotterdam Erasmus MCRotterdamActif, sans recrutement

United Kingdom

ÉtablissementVilleÉtat ou régionStatut
Saint Thomas HospitalLondonActif, sans recrutement
Saint Bartholomew's Medical CenterLondonActif, sans recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
Piedmont HealthcareAtlantaGeorgiaActif, sans recrutement
Emory UniversityAtlantaGeorgiaActif, sans recrutement
Austin HeartAustinTexasActif, sans recrutement
Medstar Union Memorial HospitalBaltimoreMarylandActif, sans recrutement
Our Lady of the Lake Regional Medical CenterBaton RougeLouisianaActif, sans recrutement
Brigham & Women'sBostonMassachusettsRetiré
Massachusetts General HospitalBostonMassachusettsActif, sans recrutement
University of BuffaloBuffaloNew YorkActif, sans recrutement
Novant Health and Vascular InstituteCharlotteNorth CarolinaActif, sans recrutement
Carolinas Medical CenterCharlotteNorth CarolinaRetiré
Rush University Medical CenterChicagoIllinoisRetiré
The Christ HospitalCincinnatiOhioActif, sans recrutement
Cleveland Clinic FoundationClevelandOhioActif, sans recrutement
Mount Carmel East HospitalColumbusOhioActif, sans recrutement
Delray Medical CenterDelray BeachFloridaRetiré
Henry FordDetroitMichiganActif, sans recrutement
Cardiac & Vascular Institute FoundationGainesvilleFloridaActif, sans recrutement
Northshore University Health SystemGlenviewIllinoisActif, sans recrutement
UT Memorial HermannHoustonTexasActif, sans recrutement
HCA Houston Healthcare Medical (SCRI)HoustonTexasActif, sans recrutement
Heart Center HospitalHuntsvilleAlabamaActif, sans recrutement
St. Vincent Heart Center of IndianaIndianapolisIndianaRetiré
Ascension St. Vincent's HospitalJacksonvilleFloridaActif, sans recrutement
University of KansasKansas CityKansasActif, sans recrutement
Saint Luke's Kansas CityKansas CityMissouriActif, sans recrutement
Scripps HealthLa JollaCaliforniaActif, sans recrutement
Dartmouth-Hitchcock Medical CenterLebanonNew HampshireActif, sans recrutement
Good Samaritan HospitalLos AngelesCaliforniaActif, sans recrutement
Kaiser Sunset LALos AngelesCaliforniaActif, sans recrutement
Cedars-Sinai Medical CenterLos AngelesCaliforniaActif, sans recrutement
UC Health Northern Colorado (Medical Center of the Rockies)LovelandColoradoActif, sans recrutement
University of WisconsinMadisonWisconsinRetiré
UPMC Heart and Vascular InstituteMechanicsburgPennsylvaniaActif, sans recrutement
Minneapolis HeartMinneapolisMinnesotaRetiré
St. Patrick HospitalMissoulaMontanaRetiré
Morristown Medical CenterMorristownNew JerseyRetiré
Intermountain Medical CenterMurrayUtahActif, sans recrutement
Naples Community HospitalNaplesFloridaActif, sans recrutement

18 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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