El ensayo ENCIRCLE (ENCIRCLE)
Sistema SAPIEN M3 Reemplazo transcatéter de válvula mitral a través de acceso transeptal
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This is a prospective single-arm, multicenter study.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Camperdown, Australia, NSW2050
- Royal Prince Alfred Hospital
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Queensland
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Chermside, Queensland, Australia, 4032
- The Prince Charles Hospital
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Toronto, Canadá, M5B 1W8
- St. Michael's
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Vancouver, Canadá, V6E 1M7
- St. Pauls
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Quebec
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Québec, Quebec, Canadá, G1V 0A6
- Laval University
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Alabama
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Huntsville, Alabama, Estados Unidos, 35801
- Heart Center Hospital
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Banner University Medical Center
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Phoenix, Arizona, Estados Unidos, 85013
- Saint Josephs Hospital Medical Center Dignity Health
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California
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La Jolla, California, Estados Unidos, 92037
- Scripps Health
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Los Angeles, California, Estados Unidos, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Estados Unidos, 90017
- Good Samaritan Hospital
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Los Angeles, California, Estados Unidos, 90071
- Kaiser Sunset LA
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San Francisco, California, Estados Unidos, 94109
- California Pacific Medical Center
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Colorado
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Loveland, Colorado, Estados Unidos, 80538
- UC Health Northern Colorado (Medical Center of the Rockies)
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Florida
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Gainesville, Florida, Estados Unidos, 32605
- Cardiac & Vascular Institute Foundation
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Jacksonville, Florida, Estados Unidos, 32204
- Ascension St. Vincent's Hospital
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Naples, Florida, Estados Unidos, 34102
- Naples Community Hospital
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Sarasota, Florida, Estados Unidos, 34239
- Sarasota Memorial Hospital
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- Emory University
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Atlanta, Georgia, Estados Unidos, 30309
- Piedmont Healthcare
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Illinois
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Glenview, Illinois, Estados Unidos, 60026
- Northshore University Health System
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
- University of Kansas
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Wichita, Kansas, Estados Unidos, 67226
- Cardiovascular Research Institute of Kansas (CRIOK)
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
- Our Lady of the Lake Regional Medical Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21218
- Medstar Union Memorial Hospital
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Saint Cloud, Minnesota, Estados Unidos, 56303
- CentraCare
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Missouri
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Kansas City, Missouri, Estados Unidos, 64111
- Saint Luke's Kansas City
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Robert Wood Johnson University Hospital
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New York
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Buffalo, New York, Estados Unidos, 14203
- University of Buffalo
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New York, New York, Estados Unidos, 10007
- Weill Cornell Medicine
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Novant Health and Vascular Institute
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- The Christ Hospital
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Cleveland, Ohio, Estados Unidos, 44122
- Cleveland Clinic Foundation
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Columbus, Ohio, Estados Unidos, 43123
- Mount Carmel East Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73120
- Oklahoma Heart Hospital
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Tulsa, Oklahoma, Estados Unidos, 74104
- Oklahoma Heart Institute
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Pennsylvania
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Mechanicsburg, Pennsylvania, Estados Unidos, 17050
- UPMC Heart and Vascular Institute
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37205
- Saint Thomas Health
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Texas
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Austin, Texas, Estados Unidos, 78705
- Austin Heart
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Houston, Texas, Estados Unidos, 77030
- UT Memorial Hermann
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Houston, Texas, Estados Unidos, 77004
- HCA Houston Healthcare Medical (SCRI)
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Utah
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Murray, Utah, Estados Unidos, 84107
- Intermountain Medical Center
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507
- Sentara Norfolk
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Roanoke, Virginia, Estados Unidos, 24014
- Carilion Roanoke Memorial Hospital
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Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington Seattle
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Petah Tikva, Israel, 4941492
- Rabin Medical Center
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Leiden, Países Bajos, 2333 ZA
- Leiden University Medical Center
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Rotterdam, Países Bajos, 3015 CE
- Rotterdam Erasmus MC
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London, Reino Unido, EC1A 7BE
- Saint Bartholomew's Medical Center
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London, Reino Unido, SE1 7EH
- Saint Thomas Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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. |
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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. |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Non-hierarchical composite of death and heart failure rehospitalization
Periodo de tiempo: 1 year
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Number of subjects with death and/or heart failure rehospitalization |
1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Improvement in NYHA functional class compared to baseline
Periodo de tiempo: 1 year
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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
Periodo de tiempo: 1 year
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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
Periodo de tiempo: 1 year
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Number of subjects with improved MR compared to baseline |
1 year
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Decrease in LVEDVi compared to baseline
Periodo de tiempo: 1 year
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Number of subjects with decreased left ventricular end-diastolic volume index (LVEDVi) compared to baseline |
1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: John Webb, MD, St. Paul's Hospital
- Investigador principal: Mayra Guerrero, MD, Mayo Clinic
- Investigador principal: David Daniels, MD, California Pacific Medical Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2018-19
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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