MedTrace Logo

The ENCIRCLE Trial

NCT04153292 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2026-02-25

No results posted yet for this study

Summary

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

  • Mitral Regurgitation
  • Mitral Valve Insufficiency

Interventions

DEVICE

SAPIEN M3 valve and dock

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

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • John Webb, MD · St. Paul's Hospital

  • Mayra Guerrero, MD · Mayo Clinic

  • David Daniels, MD · California Pacific Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2027-02-28
Completion
2031-02-28
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Israel
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153292 on ClinicalTrials.gov