ENCIRCLE-försöket (ENCIRCLE)
SAPIEN M3 System Transcatheter Mitral Valve Replacement via Transseptal Access
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a prospective single-arm, multicenter study.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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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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Alabama
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Huntsville, Alabama, Förenta staterna, 35801
- Heart Center Hospital
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Arizona
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Phoenix, Arizona, Förenta staterna, 85006
- Banner University Medical Center
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Phoenix, Arizona, Förenta staterna, 85013
- Saint Josephs Hospital Medical Center Dignity Health
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California
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La Jolla, California, Förenta staterna, 92037
- Scripps Health
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Los Angeles, California, Förenta staterna, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Förenta staterna, 90017
- Good Samaritan Hospital
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Los Angeles, California, Förenta staterna, 90071
- Kaiser Sunset LA
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San Francisco, California, Förenta staterna, 94109
- California Pacific Medical Center
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Colorado
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Loveland, Colorado, Förenta staterna, 80538
- UC Health Northern Colorado (Medical Center of the Rockies)
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Florida
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Gainesville, Florida, Förenta staterna, 32605
- Cardiac & Vascular Institute Foundation
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Jacksonville, Florida, Förenta staterna, 32204
- Ascension St. Vincent's Hospital
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Naples, Florida, Förenta staterna, 34102
- Naples Community Hospital
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Sarasota, Florida, Förenta staterna, 34239
- Sarasota Memorial Hospital
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Georgia
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Atlanta, Georgia, Förenta staterna, 30308
- Emory University
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Atlanta, Georgia, Förenta staterna, 30309
- Piedmont Healthcare
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Illinois
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Glenview, Illinois, Förenta staterna, 60026
- Northshore University Health System
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160
- University of Kansas
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Wichita, Kansas, Förenta staterna, 67226
- Cardiovascular Research Institute of Kansas (CRIOK)
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70808
- Our Lady of the Lake Regional Medical Center
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Maryland
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Baltimore, Maryland, Förenta staterna, 21218
- Medstar Union Memorial Hospital
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
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Saint Cloud, Minnesota, Förenta staterna, 56303
- CentraCare
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Missouri
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Kansas City, Missouri, Förenta staterna, 64111
- Saint Luke's Kansas City
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New Hampshire
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Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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New Brunswick, New Jersey, Förenta staterna, 08901
- Robert Wood Johnson University Hospital
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New York
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Buffalo, New York, Förenta staterna, 14203
- University of Buffalo
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New York, New York, Förenta staterna, 10007
- Weill Cornell Medicine
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28204
- Novant Health and Vascular Institute
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45219
- The Christ Hospital
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Cleveland, Ohio, Förenta staterna, 44122
- Cleveland Clinic Foundation
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Columbus, Ohio, Förenta staterna, 43123
- Mount Carmel East Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73120
- Oklahoma Heart Hospital
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Tulsa, Oklahoma, Förenta staterna, 74104
- Oklahoma Heart Institute
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Pennsylvania
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Mechanicsburg, Pennsylvania, Förenta staterna, 17050
- UPMC Heart and Vascular Institute
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37205
- Saint Thomas Health
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Texas
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Austin, Texas, Förenta staterna, 78705
- Austin Heart
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Houston, Texas, Förenta staterna, 77030
- UT Memorial Hermann
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Houston, Texas, Förenta staterna, 77004
- HCA Houston Healthcare Medical (SCRI)
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Utah
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Murray, Utah, Förenta staterna, 84107
- Intermountain Medical Center
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Virginia
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Norfolk, Virginia, Förenta staterna, 23507
- Sentara Norfolk
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Roanoke, Virginia, Förenta staterna, 24014
- Carilion Roanoke Memorial Hospital
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Washington
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Seattle, Washington, Förenta staterna, 98195
- University of Washington Seattle
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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, Nederländerna, 2333 ZA
- Leiden University Medical Center
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Rotterdam, Nederländerna, 3015 CE
- Rotterdam Erasmus MC
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London, Storbritannien, EC1A 7BE
- Saint Bartholomew's Medical Center
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London, Storbritannien, SE1 7EH
- Saint Thomas Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Non-hierarchical composite of death and heart failure rehospitalization
Tidsram: 1 year
|
Number of subjects with death and/or heart failure rehospitalization |
1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Improvement in NYHA functional class compared to baseline
Tidsram: 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
Tidsram: 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
|
|
Improvement in MR compared to baseline
Tidsram: 1 year
|
Number of subjects with improved MR compared to baseline |
1 year
|
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Decrease in LVEDVi compared to baseline
Tidsram: 1 year
|
Number of subjects with decreased left ventricular end-diastolic volume index (LVEDVi) compared to baseline |
1 year
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: John Webb, MD, St. Paul's Hospital
- Huvudutredare: Mayra Guerrero, MD, Mayo Clinic
- Huvudutredare: David Daniels, MD, California Pacific Medical Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2018-19
Plan för individuella deltagardata (IPD)
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