包围审判 (ENCIRCLE)
SAPIEN M3 系统通过经房间隔通路进行经导管二尖瓣置换术
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.
研究概览
详细说明
This is a prospective single-arm, multicenter study.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Petah Tikva、以色列、4941492
- Rabin Medical Center
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Toronto、加拿大、M5B 1W8
- St. Michael's
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Vancouver、加拿大、V6E 1M7
- St. Pauls
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Quebec
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Québec、Quebec、加拿大、G1V 0A6
- Laval University
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Camperdown、澳大利亚、NSW2050
- Royal Prince Alfred Hospital
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Queensland
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Chermside、Queensland、澳大利亚、4032
- The Prince Charles Hospital
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Alabama
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Huntsville、Alabama、美国、35801
- Heart Center Hospital
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Arizona
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Phoenix、Arizona、美国、85006
- Banner University Medical Center
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Phoenix、Arizona、美国、85013
- Saint Josephs Hospital Medical Center Dignity Health
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California
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La Jolla、California、美国、92037
- Scripps Health
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Los Angeles、California、美国、90048
- Cedars-Sinai Medical Center
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Los Angeles、California、美国、90017
- Good Samaritan Hospital
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Los Angeles、California、美国、90071
- Kaiser Sunset LA
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San Francisco、California、美国、94109
- California Pacific Medical Center
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Colorado
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Loveland、Colorado、美国、80538
- UC Health Northern Colorado (Medical Center of the Rockies)
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Florida
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Gainesville、Florida、美国、32605
- Cardiac & Vascular Institute Foundation
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Jacksonville、Florida、美国、32204
- Ascension St. Vincent's Hospital
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Naples、Florida、美国、34102
- Naples Community Hospital
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Sarasota、Florida、美国、34239
- Sarasota Memorial Hospital
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Georgia
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Atlanta、Georgia、美国、30308
- Emory University
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Atlanta、Georgia、美国、30309
- Piedmont Healthcare
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Illinois
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Glenview、Illinois、美国、60026
- Northshore University Health System
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Kansas
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Kansas City、Kansas、美国、66160
- University of Kansas
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Wichita、Kansas、美国、67226
- Cardiovascular Research Institute of Kansas (CRIOK)
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Louisiana
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Baton Rouge、Louisiana、美国、70808
- Our Lady of the Lake Regional Medical Center
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Maryland
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Baltimore、Maryland、美国、21218
- Medstar Union Memorial Hospital
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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Michigan
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Detroit、Michigan、美国、48202
- Henry Ford
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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Saint Cloud、Minnesota、美国、56303
- CentraCare
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Missouri
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Kansas City、Missouri、美国、64111
- Saint Luke's Kansas City
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New Hampshire
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Lebanon、New Hampshire、美国、03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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New Brunswick、New Jersey、美国、08901
- Robert Wood Johnson University Hospital
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New York
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Buffalo、New York、美国、14203
- University of Buffalo
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New York、New York、美国、10007
- Weill Cornell Medicine
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North Carolina
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Charlotte、North Carolina、美国、28204
- Novant Health and Vascular Institute
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Ohio
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Cincinnati、Ohio、美国、45219
- The Christ Hospital
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Cleveland、Ohio、美国、44122
- Cleveland Clinic Foundation
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Columbus、Ohio、美国、43123
- Mount Carmel East Hospital
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Oklahoma
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Oklahoma City、Oklahoma、美国、73120
- Oklahoma Heart Hospital
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Tulsa、Oklahoma、美国、74104
- Oklahoma Heart Institute
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Pennsylvania
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Mechanicsburg、Pennsylvania、美国、17050
- UPMC Heart and Vascular Institute
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Tennessee
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Nashville、Tennessee、美国、37205
- Saint Thomas Health
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Texas
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Austin、Texas、美国、78705
- Austin Heart
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Houston、Texas、美国、77030
- UT Memorial Hermann
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Houston、Texas、美国、77004
- HCA Houston Healthcare Medical (SCRI)
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Utah
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Murray、Utah、美国、84107
- Intermountain Medical Center
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Virginia
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Norfolk、Virginia、美国、23507
- Sentara Norfolk
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Roanoke、Virginia、美国、24014
- Carilion Roanoke Memorial Hospital
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Washington
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Seattle、Washington、美国、98195
- University of Washington Seattle
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London、英国、EC1A 7BE
- Saint Bartholomew's Medical Center
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London、英国、SE1 7EH
- Saint Thomas Hospital
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Leiden、荷兰、2333 ZA
- Leiden University Medical Center
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Rotterdam、荷兰、3015 CE
- Rotterdam Erasmus MC
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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实验性的：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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实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Non-hierarchical composite of death and heart failure rehospitalization
大体时间：1 year
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Number of subjects with death and/or heart failure rehospitalization |
1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement in NYHA functional class compared to baseline
大体时间：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
大体时间：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
大体时间：1 year
|
Number of subjects with improved MR compared to baseline |
1 year
|
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Decrease in LVEDVi compared to baseline
大体时间：1 year
|
Number of subjects with decreased left ventricular end-diastolic volume index (LVEDVi) compared to baseline |
1 year
|
合作者和调查者
调查人员
- 首席研究员：John Webb, MD、St. Paul's Hospital
- 首席研究员：Mayra Guerrero, MD、Mayo Clinic
- 首席研究员：David Daniels, MD、California Pacific Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.