About the trial
A prospective, multicenter, single-arm pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve replacement with the Edwards SAPIEN M3 System in patients with symptomatic, at least 3+ mitral regurgitation for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.
The ENCIRCLE Trial
This is a single-arm, multi-center study to establish the safety and effectivenes of the Edwards SAPIEN M3 Transcatheter Mitral Valve Replacement System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.
The ENCIRCLE Trial has a main study and a registry, enrolling subjects at all levels of surgical risk†
Failed Transcatheter Edge-to-Edge Repair (TEER) Registry:
Subjects must be symptomatic, have at least 3+ mitral regurgitation (MR), and have had an attempted but failed TEER procedure
† Refer to Clinical Study Protocol for full enrollment criteria
Patient Pathway through Treatment‡
prior to enrollment
In addition, there is a failed TEER registry (N=100)
Death or HF Rehospitalization at 1 Year
and annually through 5 years
‡ Refer to Clinical Study Protocol for full enrollment criteria
Eligibility and Enrollment Criteria§
- MR ≥ 3+
- NYHA functional class ≥ II
- Subject’s heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment
- Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations
- 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 >30%
- Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
- Severe right ventricular dysfunction
§ Refer to Clinical Study Protocol for full inclusion and exclusion criteria
The Edwards SAPIEN M3 Transcatheter Mitral Valve Replacement System
The SAPIEN M3 procedure is a fully transseptal mitral valve replacement therapy.Refer your patients with severe MR →
The SAPIEN M3 dock:
- Nitinol dock designed to encircle native mitral leaflets to provide an anchor for the SAPIEN M3 valve
The SAPIEN M3 valve:
- Specifically engineered to respect the native mitral anatomy
- Features the SAPIEN 3 29mm valve tissue and frame
- Includes full-frame PET skirt
We’re here for you
We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, or if you are interested in being part of this study, contact Edwards Patient Support Center. For details about the trial, visit
NCT04153292 at Clinical Trials.gov.
CAUTION – Investigational device. Limited by Federal (United States) law to investigational use.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, Edwards SAPIEN M3, ENCIRCLE, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN M3 are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks or service marks are the property of their respective owners.
Edwards Lifesciences ∙ One Edwards Way, Irvine CA 92614 USA
Important safety information
Important Safety Information: Carpentier-Edwards PERIMOUNT Aortic Bioprostheses
Indications: For use in patients whose aortic valvular disease warrants replacement of their natural or previously placed prosthetic valve.
Contraindications: Do not use if surgeon believes it would be contrary to the patient’s best interests.
Complications and side effects: Stenosis, regurgitation, endocarditis, hemolysis, thromboembolism, valve thrombosis, nonstructural dysfunction, structural valve deterioration, anemia, arrhythmia, hemorrhage, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, angina, any of which could lead to reoperation, explantation, permanent disability, and death.
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information.
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