Il processo ENCIRCLE (ENCIRCLE)
Sostituzione della valvola mitrale transcatetere del sistema SAPIEN M3 tramite accesso transettale
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
This is a prospective single-arm, multicenter study.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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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, 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, Israele, 4941492
- Rabin Medical Center
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Leiden, Olanda, 2333 ZA
- Leiden University Medical Center
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Rotterdam, Olanda, 3015 CE
- Rotterdam Erasmus MC
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London, Regno Unito, EC1A 7BE
- Saint Bartholomew's Medical Center
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London, Regno Unito, SE1 7EH
- Saint Thomas Hospital
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Alabama
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Huntsville, Alabama, Stati Uniti, 35801
- Heart Center Hospital
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006
- Banner University Medical Center
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Phoenix, Arizona, Stati Uniti, 85013
- Saint Josephs Hospital Medical Center Dignity Health
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California
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La Jolla, California, Stati Uniti, 92037
- Scripps Health
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Los Angeles, California, Stati Uniti, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Stati Uniti, 90017
- Good Samaritan Hospital
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Los Angeles, California, Stati Uniti, 90071
- Kaiser Sunset LA
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San Francisco, California, Stati Uniti, 94109
- California Pacific Medical Center
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Colorado
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Loveland, Colorado, Stati Uniti, 80538
- UC Health Northern Colorado (Medical Center of the Rockies)
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Florida
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Gainesville, Florida, Stati Uniti, 32605
- Cardiac & Vascular Institute Foundation
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Jacksonville, Florida, Stati Uniti, 32204
- Ascension St. Vincent's Hospital
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Naples, Florida, Stati Uniti, 34102
- Naples Community Hospital
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Sarasota, Florida, Stati Uniti, 34239
- Sarasota Memorial Hospital
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Georgia
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Atlanta, Georgia, Stati Uniti, 30308
- Emory University
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Atlanta, Georgia, Stati Uniti, 30309
- Piedmont Healthcare
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Illinois
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Glenview, Illinois, Stati Uniti, 60026
- Northshore University Health System
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- University of Kansas
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Wichita, Kansas, Stati Uniti, 67226
- Cardiovascular Research Institute of Kansas (CRIOK)
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70808
- Our Lady of the Lake Regional Medical Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21218
- Medstar Union Memorial Hospital
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, Stati Uniti, 48202
- Henry Ford
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic
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Saint Cloud, Minnesota, Stati Uniti, 56303
- CentraCare
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Missouri
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Kansas City, Missouri, Stati Uniti, 64111
- Saint Luke's Kansas City
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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New Brunswick, New Jersey, Stati Uniti, 08901
- Robert Wood Johnson University Hospital
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New York
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Buffalo, New York, Stati Uniti, 14203
- University of Buffalo
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New York, New York, Stati Uniti, 10007
- Weill Cornell Medicine
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28204
- Novant Health and Vascular Institute
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- The Christ Hospital
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Cleveland, Ohio, Stati Uniti, 44122
- Cleveland Clinic Foundation
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Columbus, Ohio, Stati Uniti, 43123
- Mount Carmel East Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73120
- Oklahoma Heart Hospital
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Tulsa, Oklahoma, Stati Uniti, 74104
- Oklahoma Heart Institute
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Pennsylvania
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Mechanicsburg, Pennsylvania, Stati Uniti, 17050
- UPMC Heart and Vascular Institute
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37205
- Saint Thomas Health
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Texas
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Austin, Texas, Stati Uniti, 78705
- Austin Heart
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Houston, Texas, Stati Uniti, 77030
- UT Memorial Hermann
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Houston, Texas, Stati Uniti, 77004
- HCA Houston Healthcare Medical (SCRI)
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Utah
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Murray, Utah, Stati Uniti, 84107
- Intermountain Medical Center
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Virginia
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Norfolk, Virginia, Stati Uniti, 23507
- Sentara Norfolk
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Roanoke, Virginia, Stati Uniti, 24014
- Carilion Roanoke Memorial Hospital
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Washington
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Seattle, Washington, Stati Uniti, 98195
- University of Washington Seattle
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Non-hierarchical composite of death and heart failure rehospitalization
Lasso di tempo: 1 year
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Number of subjects with death and/or heart failure rehospitalization |
1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Improvement in NYHA functional class compared to baseline
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: John Webb, MD, St. Paul's Hospital
- Investigatore principale: Mayra Guerrero, MD, Mayo Clinic
- Investigatore principale: David Daniels, MD, California Pacific Medical Center
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2018-19
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .