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NCT04153292ClinicalTrials.gov

The ENCIRCLE Trial

SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

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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…

Interventionell900 Teilnehmende gesucht68 Studienzentren6 Länder

Kategorien

Herz-Kreislauf100%

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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.

Zusammenfassung

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.

Erkrankungen

  • Mitral Regurgitation
  • Mitral Valve Insufficiency

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhaseNicht zutreffend
ZuteilungNicht randomisiert
InterventionsmodellSINGLE_GROUP
Primäres ZielTREATMENT
VerblindungNONE (0)
Teilnahme900 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Edwards Lifesciences Sponsor

Studienarme und Interventionen

  • 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.

Interventionen

  • Medizinprodukt SAPIEN M3 valve and dock

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

Endpunkte

  1. Primärer Endpunkt

    Non-hierarchical composite of death and heart failure rehospitalization

    Number of subjects with death and/or heart failure rehospitalization

    Zeitrahmen 1 year

  2. Sekundärer Endpunkt

    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.

    Zeitrahmen 1 year

  3. Sekundärer Endpunkt

    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.

    Zeitrahmen 1 year

  4. Sekundärer Endpunkt

    Improvement in MR compared to baseline

    Number of subjects with improved MR compared to baseline

    Zeitrahmen 1 year

  5. Sekundärer Endpunkt

    Decrease in LVEDVi compared to baseline

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

    Zeitrahmen 1 year

Daten

Startdatum12. November 2020 (tatsächlich)
Primärer Abschluss28. Februar 2027 (geschätzt)
Abschluss28. Februar 2031 (geschätzt)
Erstveröffentlichung6. November 2019 (tatsächlich)
Zuletzt aktualisiert25. Februar 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtFebruar 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

3 Studienzentren rekrutieren

Australia

EinrichtungStadtBundesland oder RegionStatus
Royal Prince Alfred HospitalCamperdownAktiv, rekrutiert nicht
The Prince Charles HospitalChermsideQueenslandAktiv, rekrutiert nicht

Canada

EinrichtungStadtBundesland oder RegionStatus
Laval UniversityQuébecQuebecRekrutiert
St. Michael'sTorontoRekrutiert
St. PaulsVancouverRekrutiert

Israel

EinrichtungStadtBundesland oder RegionStatus
Shaare Zedek Medical CenterJerusalemZurückgezogen
Rabin Medical CenterPetah TikvaAktiv, rekrutiert nicht
Sheba Medical CenterRamat GanZurückgezogen

Netherlands

EinrichtungStadtBundesland oder RegionStatus
Leiden University Medical CenterLeidenAktiv, rekrutiert nicht
Rotterdam Erasmus MCRotterdamAktiv, rekrutiert nicht

United Kingdom

EinrichtungStadtBundesland oder RegionStatus
Saint Thomas HospitalLondonAktiv, rekrutiert nicht
Saint Bartholomew's Medical CenterLondonAktiv, rekrutiert nicht

United States

EinrichtungStadtBundesland oder RegionStatus
Piedmont HealthcareAtlantaGeorgiaAktiv, rekrutiert nicht
Emory UniversityAtlantaGeorgiaAktiv, rekrutiert nicht
Austin HeartAustinTexasAktiv, rekrutiert nicht
Medstar Union Memorial HospitalBaltimoreMarylandAktiv, rekrutiert nicht
Our Lady of the Lake Regional Medical CenterBaton RougeLouisianaAktiv, rekrutiert nicht
Brigham & Women'sBostonMassachusettsZurückgezogen
Massachusetts General HospitalBostonMassachusettsAktiv, rekrutiert nicht
University of BuffaloBuffaloNew YorkAktiv, rekrutiert nicht
Novant Health and Vascular InstituteCharlotteNorth CarolinaAktiv, rekrutiert nicht
Carolinas Medical CenterCharlotteNorth CarolinaZurückgezogen
Rush University Medical CenterChicagoIllinoisZurückgezogen
The Christ HospitalCincinnatiOhioAktiv, rekrutiert nicht
Cleveland Clinic FoundationClevelandOhioAktiv, rekrutiert nicht
Mount Carmel East HospitalColumbusOhioAktiv, rekrutiert nicht
Delray Medical CenterDelray BeachFloridaZurückgezogen
Henry FordDetroitMichiganAktiv, rekrutiert nicht
Cardiac & Vascular Institute FoundationGainesvilleFloridaAktiv, rekrutiert nicht
Northshore University Health SystemGlenviewIllinoisAktiv, rekrutiert nicht
UT Memorial HermannHoustonTexasAktiv, rekrutiert nicht
HCA Houston Healthcare Medical (SCRI)HoustonTexasAktiv, rekrutiert nicht
Heart Center HospitalHuntsvilleAlabamaAktiv, rekrutiert nicht
St. Vincent Heart Center of IndianaIndianapolisIndianaZurückgezogen
Ascension St. Vincent's HospitalJacksonvilleFloridaAktiv, rekrutiert nicht
University of KansasKansas CityKansasAktiv, rekrutiert nicht
Saint Luke's Kansas CityKansas CityMissouriAktiv, rekrutiert nicht
Scripps HealthLa JollaCaliforniaAktiv, rekrutiert nicht
Dartmouth-Hitchcock Medical CenterLebanonNew HampshireAktiv, rekrutiert nicht
Good Samaritan HospitalLos AngelesCaliforniaAktiv, rekrutiert nicht
Kaiser Sunset LALos AngelesCaliforniaAktiv, rekrutiert nicht
Cedars-Sinai Medical CenterLos AngelesCaliforniaAktiv, rekrutiert nicht
UC Health Northern Colorado (Medical Center of the Rockies)LovelandColoradoAktiv, rekrutiert nicht
University of WisconsinMadisonWisconsinZurückgezogen
UPMC Heart and Vascular InstituteMechanicsburgPennsylvaniaAktiv, rekrutiert nicht
Minneapolis HeartMinneapolisMinnesotaZurückgezogen
St. Patrick HospitalMissoulaMontanaZurückgezogen
Morristown Medical CenterMorristownNew JerseyZurückgezogen
Intermountain Medical CenterMurrayUtahAktiv, rekrutiert nicht
Naples Community HospitalNaplesFloridaAktiv, rekrutiert nicht

18 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

Register: ClinicalTrials.gov · NCT########

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