Actively Recruiting
The ENCIRCLE Trial
Led by Edwards Lifesciences · Updated on 2026-02-25
900
Participants Needed
68
Research Sites
537 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The ENCIRCLE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Mitral regurgitation graded 3 or higher
- New York Heart Association functional class II or higher
- Commercially available surgical or transcatheter treatments deemed unsuitable by the Heart Team
- Optimized and stable heart failure management for at least 30 days before enrollment
- Provided informed consent or legal representative consent
You will not qualify if you...
- Mitral or cardiac anatomy unsuitable for SAPIEN M3 dock or valve delivery and deployment
- Unsuitable anatomy for femoral introduction and delivery of the device
- Presence of any device interfering with the SAPIEN M3 System
- Left ventricular ejection fraction below 25%
- Severe right ventricular dysfunction
- Need for aortic, tricuspid, or pulmonic valve intervention within 12 months
- History of heart transplant
- Intracardiac mass, thrombus, or vegetation seen on imaging
- Active bacterial endocarditis within 180 days
- Hemodynamic instability requiring support within 30 days
- Myocardial infarction within 30 days
- Untreated significant coronary artery disease needing revascularization
- Percutaneous or cardiovascular surgery within 30 days
- Stroke or transient ischemic attack within 90 days
- Irreversible severe pulmonary hypertension
- Chronic obstructive pulmonary disease needing home oxygen or chronic oral steroids
- Renal insufficiency or on renal replacement therapy
- Liver disease
- Planned surgery within 12 months
- Unable to tolerate antithrombotic therapy including heparin
- Active infection requiring antibiotics
- Active or recent COVID-19 infection with confounding sequelae
- Blood disorders or bleeding risks
- Refusal of blood products
- Pregnant or lactating females
- Life expectancy under 12 months due to non-cardiac issues
- Participation in other investigational studies without primary endpoint reached
- Considered part of a vulnerable population
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 68 locations
1
Heart Center Hospital
Huntsville, Alabama, United States, 35801
Active, Not Recruiting
2
Banner University Medical Center
Phoenix, Arizona, United States, 85006
Active, Not Recruiting
3
Saint Josephs Hospital Medical Center Dignity Health
Phoenix, Arizona, United States, 85013
Active, Not Recruiting
4
TMC Healthcare
Tucson, Arizona, United States, 85712
Withdrawn
5
Scripps Health
La Jolla, California, United States, 92037
Active, Not Recruiting
6
Good Samaritan Hospital
Los Angeles, California, United States, 90017
Active, Not Recruiting
7
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Active, Not Recruiting
8
Kaiser Sunset LA
Los Angeles, California, United States, 90071
Active, Not Recruiting
9
Saint Joseph Hospital
Orange, California, United States, 92868
Withdrawn
10
California Pacific Medical Center
San Francisco, California, United States, 94109
Active, Not Recruiting
11
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland, Colorado, United States, 80538
Active, Not Recruiting
12
Delray Medical Center
Delray Beach, Florida, United States, 33484
Withdrawn
13
Cardiac & Vascular Institute Foundation
Gainesville, Florida, United States, 32605
Active, Not Recruiting
14
Ascension St. Vincent's Hospital
Jacksonville, Florida, United States, 32204
Active, Not Recruiting
15
Naples Community Hospital
Naples, Florida, United States, 34102
Active, Not Recruiting
16
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Active, Not Recruiting
17
Emory University
Atlanta, Georgia, United States, 30308
Active, Not Recruiting
18
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
Active, Not Recruiting
19
Rush University Medical Center
Chicago, Illinois, United States, 60612
Withdrawn
20
Northshore University Health System
Glenview, Illinois, United States, 60026
Active, Not Recruiting
21
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
Withdrawn
22
University of Kansas
Kansas City, Kansas, United States, 66160
Active, Not Recruiting
23
Cardiovascular Research Institute of Kansas (CRIOK)
Wichita, Kansas, United States, 67226
Active, Not Recruiting
24
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States, 70808
Active, Not Recruiting
25
Medstar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Active, Not Recruiting
26
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Active, Not Recruiting
27
Brigham & Women's
Boston, Massachusetts, United States, 02115
Withdrawn
28
Henry Ford
Detroit, Michigan, United States, 48202
Active, Not Recruiting
29
Minneapolis Heart
Minneapolis, Minnesota, United States, 55407
Withdrawn
30
Mayo Clinic
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
31
CentraCare
Saint Cloud, Minnesota, United States, 56303
Active, Not Recruiting
32
Saint Luke's Kansas City
Kansas City, Missouri, United States, 64111
Active, Not Recruiting
33
St. Patrick Hospital
Missoula, Montana, United States, 59802
Withdrawn
34
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Active, Not Recruiting
35
Morristown Medical Center
Morristown, New Jersey, United States, 07962
Withdrawn
36
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Active, Not Recruiting
37
University of Buffalo
Buffalo, New York, United States, 14203
Active, Not Recruiting
38
Weill Cornell Medicine
New York, New York, United States, 10007
Active, Not Recruiting
39
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Withdrawn
40
Novant Health and Vascular Institute
Charlotte, North Carolina, United States, 28204
Active, Not Recruiting
41
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Active, Not Recruiting
42
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44122
Active, Not Recruiting
43
Mount Carmel East Hospital
Columbus, Ohio, United States, 43123
Active, Not Recruiting
44
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
Active, Not Recruiting
45
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74104
Active, Not Recruiting
46
UPMC Heart and Vascular Institute
Mechanicsburg, Pennsylvania, United States, 17050
Active, Not Recruiting
47
Alleghany General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Withdrawn
48
Saint Thomas Health
Nashville, Tennessee, United States, 37205
Active, Not Recruiting
49
Austin Heart
Austin, Texas, United States, 78705
Active, Not Recruiting
50
HCA Houston Healthcare Medical (SCRI)
Houston, Texas, United States, 77004
Active, Not Recruiting
51
UT Memorial Hermann
Houston, Texas, United States, 77030
Active, Not Recruiting
52
Intermountain Medical Center
Murray, Utah, United States, 84107
Active, Not Recruiting
53
Sentara Norfolk
Norfolk, Virginia, United States, 23507
Active, Not Recruiting
54
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24014
Active, Not Recruiting
55
University of Washington Seattle
Seattle, Washington, United States, 98195
Active, Not Recruiting
56
University of Wisconsin
Madison, Wisconsin, United States, 53792-3248
Withdrawn
57
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Active, Not Recruiting
58
Royal Prince Alfred Hospital
Camperdown, Australia, NSW2050
Active, Not Recruiting
59
Laval University
Québec, Quebec, Canada, G1V 0A6
Actively Recruiting
60
St. Michael's
Toronto, Canada, M5B 1W8
Actively Recruiting
61
St. Pauls
Vancouver, Canada, V6E 1M7
Actively Recruiting
62
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Withdrawn
63
Rabin Medical Center
Petah Tikva, Israel, 4941492
Active, Not Recruiting
64
Sheba Medical Center
Ramat Gan, Israel, 5211401
Withdrawn
65
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Active, Not Recruiting
66
Rotterdam Erasmus MC
Rotterdam, Netherlands, 3015 CE
Active, Not Recruiting
67
Saint Bartholomew's Medical Center
London, United Kingdom, EC1A 7BE
Active, Not Recruiting
68
Saint Thomas Hospital
London, United Kingdom, SE1 7EH
Active, Not Recruiting
Research Team
E
Edwards TMTT Clinical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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