The ENCIRCLE Trial

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Edwards Lifesciences
Study ID
NCT04153292
Status
Recruiting
Apply to this trial

Conditions

  • Mitral Regurgitation
  • Mitral Valve Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SAPIEN M3 valve and dock — DEVICE
    During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.

Study Details

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.

Key Dates

Start date
Nov 12, 2020
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2031

Study Design

Enrollment
900 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TMVR - Main Cohort
    Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR).
  • Experimental: TMVR - Failed TEER Registry
    Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.
  • Experimental: TMVR - MAC Registry
    Subjects with mitral annular calcification (MAC) will have TMVR.

Primary Outcome Measure

Non-hierarchical composite of death and heart failure rehospitalization [ Time Frame: 1 year ]

Central Contacts

Locations (56)

FacilityCityStateZIPSite coordinators
Heart Center HospitalHuntsvilleAlabama35801-
Banner University Medical CenterPhoenixArizona85006-
Saint Josephs Hospital Medical Center Dignity HealthPhoenixArizona85013-
TMC HealthcareTucsonArizona85712-
Scripps HealthLa JollaCalifornia92037-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Good Samaritan HospitalLos AngelesCalifornia90017-
Kaiser Sunset LALos AngelesCalifornia90071-
Saint Joseph HospitalOrangeCalifornia92868-
California Pacific Medical CenterSan FranciscoCalifornia94109-
UC Health Northern Colorado (Medical Center of the Rockies)LovelandColorado80538-
Delray Medical CenterDelray BeachFlorida33484-
Cardiac & Vascular Institute FoundationGainesvilleFlorida32605-
Ascension St. Vincent's HospitalJacksonvilleFlorida32204-
Naples Community HospitalNaplesFlorida34102-
Sarasota Memorial HospitalSarasotaFlorida34239-
Emory UniversityAtlantaGeorgia30308-
Piedmont HealthcareAtlantaGeorgia30309-
Rush University Medical CenterChicagoIllinois60612-
Northshore University Health SystemGlenviewIllinois60026-
St. Vincent Heart Center of IndianaIndianapolisIndiana46290-
University of KansasKansas CityKansas66160-
Cardiovascular Research Institute of Kansas (CRIOK)WichitaKansas67226-
Our Lady of the Lake Regional Medical CenterBaton RougeLouisiana70808-
Medstar Union Memorial HospitalBaltimoreMaryland21218-
Brigham & Women'sBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Henry FordDetroitMichigan48202-
Minneapolis HeartMinneapolisMinnesota55407-
Mayo ClinicRochesterMinnesota55905-
CentraCareSaint CloudMinnesota56303-
Saint Luke's Kansas CityKansas CityMissouri64111-
St. Patrick HospitalMissoulaMontana59802-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Morristown Medical CenterMorristownNew Jersey07962-
Robert Wood Johnson University HospitalNew BrunswickNew Jersey08901-
University of BuffaloBuffaloNew York14203-
Weill Cornell MedicineNew YorkNew York10007-
Carolinas Medical CenterCharlotteNorth Carolina28203-
Novant Health and Vascular InstituteCharlotteNorth Carolina28204-
The Christ HospitalCincinnatiOhio45219-
Cleveland Clinic FoundationClevelandOhio44122-
Mount Carmel East HospitalColumbusOhio43123-
Oklahoma Heart HospitalOklahoma CityOklahoma73120-
Oklahoma Heart InstituteTulsaOklahoma74104-
UPMC Heart and Vascular InstituteMechanicsburgPennsylvania17050-
Alleghany General HospitalPittsburghPennsylvania15212-
Saint Thomas HealthNashvilleTennessee37205-
Austin HeartAustinTexas78705-
HCA Houston Healthcare Medical (SCRI)HoustonTexas77004-
UT Memorial HermannHoustonTexas77030-
Intermountain Medical CenterMurrayUtah84107-
Sentara NorfolkNorfolkVirginia23507-
Carilion Roanoke Memorial HospitalRoanokeVirginia24014-
University of Washington SeattleSeattleWashington98195-
University of WisconsinMadisonWisconsin53792-3248-

Find similar trials in Huntsville, AL

By research site
Heart Center Hospital· Huntsville, ALBanner University Medical Center· Phoenix, AZSaint Josephs Hospital Medical Center Dignity Health· Phoenix, AZTMC Healthcare· Tucson, AZScripps Health· La Jolla, CACedars-Sinai Medical Center· Los Angeles, CA

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