The ENCIRCLE Trial

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.

Refer your patients with severe MR →

Mitral Regurgitation Classification

Mitral regurgitation (MR) etiology can be categorized into primary or secondary. In primary MR (also knows as degenerative), there is an abnormality in one or more components of the mitral apparatus (leaflets, annulus, chordae tendineae, papillary muscles). In secondary MR (also known as functional), the valve itself is usually normal but mitral insufficiency arises from alterations in left ventricular (LV) geometry.

MR can also be described by the Carpentier classification*, which categorizes MR based on leaflet motion. There are four types – Type 1, Type 2, Type IIIa, and Type IIIb. Type 1 refers to mitral leaflets with normal motion, and includes annular dilatation, dilated cardiomyopathies, cleft, or perforation. Type II refers to mitral leaflets with increased mobility, so instances of prolapse or flail. Type IIIa refers to mitral leaflets that are restricted in both systole and diastole – including leaflets that are thickened and/or calcified due to rheumatic heart disease or stenosis. Type IIIb refers to mitral leaflets that are restricted only in systole, including LV wall motion abnormalities or left ventricular dilatation that result in chordal tethering.

* Carpentier A, Adams DH, and Filsoufi F. Carpentier's Reconstructive Valve Surgery. Saunders/Elsevier, 2010.

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The ENCIRCLE trial is studying the SAPIEN M3 system in patients with symptomatic, at least 3+ MR of primary or secondary etiology and Carpentier functional classifications Type I, II, IIIa or IIIb. (All enrollment criteria must be met.)

The ENCIRCLE Trial

Purpose

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.


Design

The ENCIRCLE Trial has a main study and a registry, enrolling subjects at all levels of surgical risk

Two women

Main Study

Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR)

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

MR≥ 3+
Stable Heart Failure Medication for 30 Day
prior to enrollment
Evaluation by a heart team
(All risk)
Commercially Unsuitable (N = Up to 300)
In addition, there is a failed TEER registry (N=100)
Primary Endpoint:
Death or HF Rehospitalization at 1 Year
Follow-up 30 days, 6 months, 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
The Edwards SAPIEN M3 System

Watch the SAPIEN M3 system procedural animation

Support Agent

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.

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Give us a call
(888) 713-1564

CAUTION – Investigational device. Limited by Federal (United States) law to investigational use.

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

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