The ENCIRCLE Trial
- Conditions
- Mitral RegurgitationMitral Valve Insufficiency
- Interventions
- Device: SAPIEN M3 valve and dock
- Registration Number
- NCT04153292
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
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.
- Detailed Description
This is a prospective single-arm, multicenter study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 900
- 18 years of age or older
- MR โฅ 3+
- NYHA functional class โฅ 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TMVR - Main Cohort SAPIEN M3 valve and dock Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR). TMVR - MAC Registry SAPIEN M3 valve and dock Subjects with mitral annular calcification (MAC) will have TMVR. TMVR - Failed TEER Registry SAPIEN M3 valve and dock Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.
- Primary Outcome Measures
Name Time Method Non-hierarchical composite of death and heart failure rehospitalization 1 year Number of subjects with death and/or heart failure rehospitalization
- Secondary Outcome Measures
Name Time Method Improvement in MR compared to baseline 1 year Number of subjects with improved MR compared to baseline
Improvement in NYHA functional class compared to baseline 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.
Improvement in KCCQ Overall Score compared to baseline 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.
Decrease in LVEDVi compared to baseline 1 year Number of subjects with decreased left ventricular end-diastolic volume index (LVEDVi) compared to baseline
Trial Locations
- Locations (68)
Dartmouth-Hitchcock Medical Center
๐บ๐ธLebanon, New Hampshire, United States
Morristown Medical Center
๐บ๐ธMorristown, New Jersey, United States
Mount Carmel East Hospital
๐บ๐ธColumbus, Ohio, United States
Heart Center Hospital
๐บ๐ธHuntsville, Alabama, United States
Banner University Medical Center
๐บ๐ธPhoenix, Arizona, United States
Arizona Cardiovascular Research Center
๐บ๐ธPhoenix, Arizona, United States
TMC Healthcare
๐บ๐ธTucson, Arizona, United States
Scripps Health
๐บ๐ธLa Jolla, California, United States
Good Samaritan Hospital
๐บ๐ธLos Angeles, California, United States
Cedars-Sinai Medical Center
๐บ๐ธLos Angeles, California, United States
Kaiser Sunset LA
๐บ๐ธLos Angeles, California, United States
Saint Joseph Hospital
๐บ๐ธOrange, California, United States
California Pacific Medical Center
๐บ๐ธSan Francisco, California, United States
UC Health Northern Colorado (Medical Center of the Rockies)
๐บ๐ธLoveland, Colorado, United States
Delray Medical Center
๐บ๐ธDelray Beach, Florida, United States
Cardiac & Vascular Institute Foundation
๐บ๐ธGainesville, Florida, United States
Ascension St. Vincent's Hospital
๐บ๐ธJacksonville, Florida, United States
Naples Community Hospital
๐บ๐ธNaples, Florida, United States
Sarasota Memorial Hospital
๐บ๐ธSarasota, Florida, United States
Emory University
๐บ๐ธAtlanta, Georgia, United States
Piedmont Healthcare
๐บ๐ธAtlanta, Georgia, United States
Rush University Medical Center
๐บ๐ธChicago, Illinois, United States
Northshore University Health System
๐บ๐ธGlenview, Illinois, United States
St. Vincent Heart Center of Indiana
๐บ๐ธIndianapolis, Indiana, United States
University of Kansas
๐บ๐ธKansas City, Kansas, United States
Cardiovascular Research Institute of Kansas (CRIOK)
๐บ๐ธWichita, Kansas, United States
Our Lady of the Lake Regional Medical Center
๐บ๐ธBaton Rouge, Louisiana, United States
Medstar Union Memorial Hospital
๐บ๐ธBaltimore, Maryland, United States
Massachusetts General Hospital
๐บ๐ธBoston, Massachusetts, United States
Brigham & Women's
๐บ๐ธBoston, Massachusetts, United States
Henry Ford
๐บ๐ธDetroit, Michigan, United States
Minneapolis Heart
๐บ๐ธMinneapolis, Minnesota, United States
Mayo Clinic
๐บ๐ธRochester, Minnesota, United States
CentraCare
๐บ๐ธSaint Cloud, Minnesota, United States
Saint Luke's Kansas City
๐บ๐ธKansas City, Missouri, United States
St. Patrick Hospital
๐บ๐ธMissoula, Montana, United States
Robert Wood Johnson University Hospital
๐บ๐ธNew Brunswick, New Jersey, United States
University of Buffalo
๐บ๐ธBuffalo, New York, United States
Weill Cornell Medicine
๐บ๐ธNew York, New York, United States
Carolinas Medical Center
๐บ๐ธCharlotte, North Carolina, United States
Novant Health and Vascular Institute
๐บ๐ธCharlotte, North Carolina, United States
The Christ Hospital
๐บ๐ธCincinnati, Ohio, United States
Cleveland Clinic Foundation
๐บ๐ธCleveland, Ohio, United States
Oklahoma Heart Hospital
๐บ๐ธOklahoma City, Oklahoma, United States
Oklahoma Heart Institute
๐บ๐ธTulsa, Oklahoma, United States
UPMC Heart and Vascular Institute
๐บ๐ธMechanicsburg, Pennsylvania, United States
Alleghany General Hospital
๐บ๐ธPittsburgh, Pennsylvania, United States
Saint Thomas Health
๐บ๐ธNashville, Tennessee, United States
Austin Heart
๐บ๐ธAustin, Texas, United States
HCA Houston Healthcare Medical (SCRI)
๐บ๐ธHouston, Texas, United States
UT Memorial Hermann
๐บ๐ธHouston, Texas, United States
Intermountain Medical Center
๐บ๐ธMurray, Utah, United States
Sentara Norfolk
๐บ๐ธNorfolk, Virginia, United States
Carilion Roanoke Memorial Hospital
๐บ๐ธRoanoke, Virginia, United States
University of Washington Seattle
๐บ๐ธSeattle, Washington, United States
University of Wisconsin
๐บ๐ธMadison, Wisconsin, United States
The Prince Charles Hospital
๐ฆ๐บChermside, Queensland, Australia
Royal Prince Alfred Hospital
๐ฆ๐บCamperdown, Australia
Laval University
๐จ๐ฆQuebec City, Quebec, Canada
St. Michael's
๐จ๐ฆToronto, Canada
St. Pauls
๐จ๐ฆVancouver, Canada
Shaare Zedek Medical Center
๐ฎ๐ฑJerusalem, Israel
Rabin Medical Center
๐ฎ๐ฑPetah Tikva, Israel
Sheba Medical Center
๐ฎ๐ฑRamat Gan, Israel
Leiden University Medical Center
๐ณ๐ฑLeiden, South Holland, Netherlands
Rotterdam Erasmus MC
๐ณ๐ฑRotterdam, South Holland, Netherlands
Saint Thomas Hospital
๐ฌ๐งLondon, United Kingdom
Saint Bartholomew's Medical Center
๐ฌ๐งOxford, United Kingdom