Der ENCIRCLE-Prozess (ENCIRCLE)
SAPIEN M3 System Transkatheter Mitralklappenersatz über transseptalen Zugang
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is a prospective single-arm, multicenter study.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Camperdown, Australien, NSW2050
- Royal Prince Alfred Hospital
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Queensland
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Chermside, Queensland, Australien, 4032
- The Prince Charles Hospital
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Petah Tikva, Israel, 4941492
- Rabin Medical Center
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Toronto, Kanada, M5B 1W8
- St. Michael's
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Vancouver, Kanada, V6E 1M7
- St. Pauls
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Quebec
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Québec, Quebec, Kanada, G1V 0A6
- Laval University
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Leiden, Niederlande, 2333 ZA
- Leiden University Medical Center
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Rotterdam, Niederlande, 3015 CE
- Rotterdam Erasmus MC
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Alabama
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Huntsville, Alabama, Vereinigte Staaten, 35801
- Heart Center Hospital
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85006
- Banner University Medical Center
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Phoenix, Arizona, Vereinigte Staaten, 85013
- Saint Josephs Hospital Medical Center Dignity Health
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California
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La Jolla, California, Vereinigte Staaten, 92037
- Scripps Health
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Los Angeles, California, Vereinigte Staaten, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Vereinigte Staaten, 90017
- Good Samaritan Hospital
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Los Angeles, California, Vereinigte Staaten, 90071
- Kaiser Sunset LA
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San Francisco, California, Vereinigte Staaten, 94109
- California Pacific Medical Center
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Colorado
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Loveland, Colorado, Vereinigte Staaten, 80538
- UC Health Northern Colorado (Medical Center of the Rockies)
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Florida
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Gainesville, Florida, Vereinigte Staaten, 32605
- Cardiac & Vascular Institute Foundation
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Jacksonville, Florida, Vereinigte Staaten, 32204
- Ascension St. Vincent's Hospital
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Naples, Florida, Vereinigte Staaten, 34102
- Naples Community Hospital
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Sarasota, Florida, Vereinigte Staaten, 34239
- Sarasota Memorial Hospital
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30308
- Emory University
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Atlanta, Georgia, Vereinigte Staaten, 30309
- Piedmont Healthcare
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Illinois
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Glenview, Illinois, Vereinigte Staaten, 60026
- Northshore University Health System
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Kansas
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Kansas City, Kansas, Vereinigte Staaten, 66160
- University of Kansas
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Wichita, Kansas, Vereinigte Staaten, 67226
- Cardiovascular Research Institute of Kansas (CRIOK)
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Louisiana
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Baton Rouge, Louisiana, Vereinigte Staaten, 70808
- Our Lady of the Lake Regional Medical Center
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21218
- Medstar Union Memorial Hospital
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, Vereinigte Staaten, 48202
- Henry Ford
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Minnesota
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Rochester, Minnesota, Vereinigte Staaten, 55905
- Mayo Clinic
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Saint Cloud, Minnesota, Vereinigte Staaten, 56303
- CentraCare
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Missouri
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Kansas City, Missouri, Vereinigte Staaten, 64111
- Saint Luke's Kansas City
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New Hampshire
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Lebanon, New Hampshire, Vereinigte Staaten, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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New Brunswick, New Jersey, Vereinigte Staaten, 08901
- Robert Wood Johnson University Hospital
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New York
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Buffalo, New York, Vereinigte Staaten, 14203
- University of Buffalo
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New York, New York, Vereinigte Staaten, 10007
- Weill Cornell Medicine
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North Carolina
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Charlotte, North Carolina, Vereinigte Staaten, 28204
- Novant Health and Vascular Institute
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45219
- The Christ Hospital
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Cleveland, Ohio, Vereinigte Staaten, 44122
- Cleveland Clinic Foundation
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Columbus, Ohio, Vereinigte Staaten, 43123
- Mount Carmel East Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73120
- Oklahoma Heart Hospital
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Tulsa, Oklahoma, Vereinigte Staaten, 74104
- Oklahoma Heart Institute
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Pennsylvania
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Mechanicsburg, Pennsylvania, Vereinigte Staaten, 17050
- UPMC Heart and Vascular Institute
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37205
- Saint Thomas Health
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Texas
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Austin, Texas, Vereinigte Staaten, 78705
- Austin Heart
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Houston, Texas, Vereinigte Staaten, 77030
- UT Memorial Hermann
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Houston, Texas, Vereinigte Staaten, 77004
- HCA Houston Healthcare Medical (SCRI)
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Utah
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Murray, Utah, Vereinigte Staaten, 84107
- Intermountain Medical Center
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Virginia
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Norfolk, Virginia, Vereinigte Staaten, 23507
- Sentara Norfolk
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Roanoke, Virginia, Vereinigte Staaten, 24014
- Carilion Roanoke Memorial Hospital
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Washington
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Seattle, Washington, Vereinigte Staaten, 98195
- University of Washington Seattle
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London, Vereinigtes Königreich, EC1A 7BE
- Saint Bartholomew's Medical Center
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London, Vereinigtes Königreich, SE1 7EH
- Saint Thomas Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 18 years of age or older
- MR ≥ 3+
- NYHA functional class ≥ II
- Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
- 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.
- 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:
- Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve
- Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
- Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
- Left ventricular ejection fraction <25%
- Severe right ventricular dysfunction
- Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
- History of heart transplant
- Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- Active bacterial endocarditis within 180 days of the procedure
- Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure
- Myocardial infarction within 30 days of the procedure
- Clinically significant untreated coronary artery disease requiring revascularization
- Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure
- Stroke or transient ischemic attack within 90 days of the procedure
- Irreversible, severe pulmonary hypertension
- Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
- Renal insufficiency or receiving renal replacement therapy
- Liver disease
- Planned surgery within the next 12 months
- Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure
- Active infection requiring current antibiotic therapy
- Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
- Refusal of blood products
- Female who is pregnant or lactating
- Estimated life expectancy <12 months due to non-cardiac conditions
- Participating in another investigational drug or device study that has not reached its primary endpoint
- Subject considered to be part of a vulnerable population
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: TMVR - Main Cohort
Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR). |
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach. |
|
Experimental: TMVR - Failed TEER Registry
Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR. |
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach. |
|
Experimental: TMVR - MAC Registry
Subjects with mitral annular calcification (MAC) will have TMVR. |
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Non-hierarchical composite of death and heart failure rehospitalization
Zeitfenster: 1 year
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Number of subjects with death and/or heart failure rehospitalization |
1 year
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Improvement in NYHA functional class compared to baseline
Zeitfenster: 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
|
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Improvement in KCCQ Overall Score compared to baseline
Zeitfenster: 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
|
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Improvement in MR compared to baseline
Zeitfenster: 1 year
|
Number of subjects with improved MR compared to baseline |
1 year
|
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Decrease in LVEDVi compared to baseline
Zeitfenster: 1 year
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Number of subjects with decreased left ventricular end-diastolic volume index (LVEDVi) compared to baseline |
1 year
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: John Webb, MD, St. Paul's Hospital
- Hauptermittler: Mayra Guerrero, MD, Mayo Clinic
- Hauptermittler: David Daniels, MD, California Pacific Medical Center
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2018-19
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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