Le procès ENCIRCLE (ENCIRCLE)
Remplacement de la valve mitrale par transcathéter du système SAPIEN M3 via un accès transseptal
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a prospective single-arm, multicenter study.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Camperdown, Australie, NSW2050
- Royal Prince Alfred Hospital
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Queensland
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Chermside, Queensland, Australie, 4032
- The Prince Charles Hospital
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Toronto, Canada, M5B 1W8
- St. Michael's
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Vancouver, Canada, V6E 1M7
- St. Pauls
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Quebec
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Québec, Quebec, Canada, G1V 0A6
- Laval University
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Petah Tikva, Israël, 4941492
- Rabin Medical Center
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Leiden, Pays-Bas, 2333 ZA
- Leiden University Medical Center
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Rotterdam, Pays-Bas, 3015 CE
- Rotterdam Erasmus MC
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London, Royaume-Uni, EC1A 7BE
- Saint Bartholomew's Medical Center
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London, Royaume-Uni, SE1 7EH
- Saint Thomas Hospital
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Alabama
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Huntsville, Alabama, États-Unis, 35801
- Heart Center Hospital
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Arizona
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Phoenix, Arizona, États-Unis, 85006
- Banner University Medical Center
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Phoenix, Arizona, États-Unis, 85013
- Saint Josephs Hospital Medical Center Dignity Health
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California
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La Jolla, California, États-Unis, 92037
- Scripps Health
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Los Angeles, California, États-Unis, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, États-Unis, 90017
- Good Samaritan Hospital
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Los Angeles, California, États-Unis, 90071
- Kaiser Sunset LA
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San Francisco, California, États-Unis, 94109
- California Pacific Medical Center
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Colorado
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Loveland, Colorado, États-Unis, 80538
- UC Health Northern Colorado (Medical Center of the Rockies)
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Florida
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Gainesville, Florida, États-Unis, 32605
- Cardiac & Vascular Institute Foundation
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Jacksonville, Florida, États-Unis, 32204
- Ascension St. Vincent's Hospital
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Naples, Florida, États-Unis, 34102
- Naples Community Hospital
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Sarasota, Florida, États-Unis, 34239
- Sarasota Memorial Hospital
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Georgia
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Atlanta, Georgia, États-Unis, 30308
- Emory University
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Atlanta, Georgia, États-Unis, 30309
- Piedmont Healthcare
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Illinois
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Glenview, Illinois, États-Unis, 60026
- Northshore University Health System
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- University of Kansas
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Wichita, Kansas, États-Unis, 67226
- Cardiovascular Research Institute of Kansas (CRIOK)
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Louisiana
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Baton Rouge, Louisiana, États-Unis, 70808
- Our Lady of the Lake Regional Medical Center
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Maryland
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Baltimore, Maryland, États-Unis, 21218
- Medstar Union Memorial Hospital
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, États-Unis, 48202
- Henry Ford
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
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Saint Cloud, Minnesota, États-Unis, 56303
- CentraCare
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Missouri
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Kansas City, Missouri, États-Unis, 64111
- Saint Luke's Kansas City
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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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New Brunswick, New Jersey, États-Unis, 08901
- Robert Wood Johnson University Hospital
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New York
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Buffalo, New York, États-Unis, 14203
- University of Buffalo
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New York, New York, États-Unis, 10007
- Weill Cornell Medicine
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North Carolina
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Charlotte, North Carolina, États-Unis, 28204
- Novant Health and Vascular Institute
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Ohio
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Cincinnati, Ohio, États-Unis, 45219
- The Christ Hospital
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Cleveland, Ohio, États-Unis, 44122
- Cleveland Clinic Foundation
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Columbus, Ohio, États-Unis, 43123
- Mount Carmel East Hospital
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73120
- Oklahoma Heart Hospital
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Tulsa, Oklahoma, États-Unis, 74104
- Oklahoma Heart Institute
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Pennsylvania
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Mechanicsburg, Pennsylvania, États-Unis, 17050
- UPMC Heart and Vascular Institute
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Tennessee
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Nashville, Tennessee, États-Unis, 37205
- Saint Thomas Health
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Texas
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Austin, Texas, États-Unis, 78705
- Austin Heart
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Houston, Texas, États-Unis, 77030
- UT Memorial Hermann
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Houston, Texas, États-Unis, 77004
- HCA Houston Healthcare Medical (SCRI)
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Utah
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Murray, Utah, États-Unis, 84107
- Intermountain Medical Center
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Virginia
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Norfolk, Virginia, États-Unis, 23507
- Sentara Norfolk
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Roanoke, Virginia, États-Unis, 24014
- Carilion Roanoke Memorial Hospital
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Washington
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Seattle, Washington, États-Unis, 98195
- University of Washington Seattle
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Expérimental: 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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Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Non-hierarchical composite of death and heart failure rehospitalization
Délai: 1 year
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Number of subjects with death and/or heart failure rehospitalization |
1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Improvement in NYHA functional class compared to baseline
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: John Webb, MD, St. Paul's Hospital
- Chercheur principal: Mayra Guerrero, MD, Mayo Clinic
- Chercheur principal: David Daniels, MD, California Pacific Medical Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2018-19
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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