The ENCIRCLE Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEdwards Lifesciences
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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%
Trial design
Treatments tested in this trial
- SAPIEN M3 valve and dock
Treatment groups
900 Participants
are divided into 3 treatment groupsLocations
68Australia
The Prince Charles Hospital4032, ChermsideQueensland, Australia
Royal Prince Alfred HospitalNSW2050, Camperdown Australia
Canada
Laval UniversityG1V 0A6, QuébecQuebec, Canada
St. Michael'sM5B 1W8, Toronto Canada
Sponsors and collaborators
Edwards Lifesciences
Lead sponsor
Source ClinicalTrials.gov