The ENCIRCLE Trial
Public ClinicalTrials.gov record NCT04153292. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04153292
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 786 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 12, 2020 (Actual)
- Primary completion
- Oct 10, 2027 (Estimated)
- Completion
- Oct 10, 2031 (Estimated)
- Last update posted
- Oct 6, 2026
2020 – 2031
United States locations
- U.S. sites
- 44
- U.S. states
- 26
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Heart Center Hospital | Huntsville | Alabama | 35801 | — |
| Banner University Medical Center | Phoenix | Arizona | 85006 | — |
| Saint Josephs Hospital Medical Center Dignity Health | Phoenix | Arizona | 85013 | — |
| Scripps Health | La Jolla | California | 92037 | — |
| Good Samaritan Hospital | Los Angeles | California | 90017 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Kaiser Sunset LA | Los Angeles | California | 90071 | — |
| California Pacific Medical Center | San Francisco | California | 94109 | — |
| UC Health Northern Colorado (Medical Center of the Rockies) | Loveland | Colorado | 80538 | — |
| Cardiac & Vascular Institute Foundation | Gainesville | Florida | 32605 | — |
| Ascension St. Vincent's Hospital | Jacksonville | Florida | 32204 | — |
| Naples Community Hospital | Naples | Florida | 34102 | — |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | — |
| Emory University | Atlanta | Georgia | 30308 | — |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | — |
| Northshore University Health System | Glenview | Illinois | 60026 | — |
| University of Kansas | Kansas City | Kansas | 66160 | — |
| Cardiovascular Research Institute of Kansas (CRIOK) | Wichita | Kansas | 67226 | — |
| Our Lady of the Lake Regional Medical Center | Baton Rouge | Louisiana | 70808 | — |
| Medstar Union Memorial Hospital | Baltimore | Maryland | 21218 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Henry Ford | Detroit | Michigan | 48202 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| CentraCare | Saint Cloud | Minnesota | 56303 | — |
| Saint Luke's Kansas City | Kansas City | Missouri | 64111 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | — |
| University of Buffalo | Buffalo | New York | 14203 | — |
| Weill Cornell Medicine | New York | New York | 10007 | — |
| Novant Health and Vascular Institute | Charlotte | North Carolina | 28204 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44122 | — |
| Mount Carmel East Hospital | Columbus | Ohio | 43123 | — |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | — |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74104 | — |
| UPMC Heart and Vascular Institute | Mechanicsburg | Pennsylvania | 17050 | — |
| Saint Thomas Health | Nashville | Tennessee | 37205 | — |
| Austin Heart | Austin | Texas | 78705 | — |
| HCA Houston Healthcare Medical (SCRI) | Houston | Texas | 77004 | — |
| UT Memorial Hermann | Houston | Texas | 77030 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| Sentara Norfolk | Norfolk | Virginia | 23507 | — |
| Carilion Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | — |
| University of Washington Seattle | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04153292, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 6, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04153292 live on ClinicalTrials.gov.