ENCIRCLE Trial
Protocol Description
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. There is no approved transcatheter option for transcatheter mitral valve replacement leaving few options for patients ineligible for open heart surgery.
Eligibility Criteria
Inclusion Criteria
- 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
- MR ≥ 3+
- 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 (see Failed TEER Registry). Note: Subjects who require significant changes to heart failure medication after enrollment but prior to the procedure must re-stabilize for 30 days to be eligible.
Exclusion Criteria
Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the dock or valve, including but not limited to:
- Commissural diameter > 45 mm as assessed by computed tomography (CT) core lab
- Commissural jet, flail or prolapse that could potentially increase the risk of paravalvular leak
- Calcification that would interfere with the SAPIEN M3 system during delivery or after implantation
- Interatrial septum or left atrium not suitable for transcatheter transseptal access
- LVEDD ≥ 70 mm as assessed by echocardiography (Echo) core lab
- Left ventricular end-systolic diameter (LVESD) < 35 mm (1 cm below annulus) as assessed by CT core lab
- Significant risk of LVOT obstruction as assessed by CT core lab
Principal Investigator
Jason Foerst, MD., is the medical director of the Structural Heart and Valve Center at Carilion Clinic and an assistant professor of Medicine at the Virginia Tech Carilion School of Medicine.
