Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

This is a prospective, single-arm, multi-center study to be conducted in the US and outside
the US (OUS). Approximately 250 subjects are planned to be enrolled to obtain long term data
from 101 subjects at 8 years post implant of the Magna mitral valve. Of these 250,
approximately 38 (15%) are anticipated to be simultaneous aortic and mitral replacements.
Subject enrollment will not start in the US before obtaining FDA approval of this post market
study.

Assessments will be obtained for the preoperative and operative visits, and postoperatively
at discharge, six months, 1-year and annually thereafter for a minimum of 8 years. Subject's
demographics (date of birth, sex), physical assessment (heart rate, height, weight, systolic
and diastolic blood pressures), New York Heart Association (NYHA) functional class, cardiac
rhythm, cardiovascular medical history/risk factors, non-cardiovascular conditions, previous
cardiovascular procedures/interventions, antithromboembolic and lipid lowering medications
and coagulation profile. Blood data is required for each subject preoperatively and at 6
months. Echocardiographic evaluation required for each subject preoperatively, at discharge,
6 months (between 3-6 months), 1, 2, 4, 6, and 8 year follow-ups. A QOL survey (EQ-5D) will
be completed by the subject pre-operatively and at the 6-month follow-up visit.

Inclusion Criteria:

- The patient requires, as indicated in the preoperative evaluation, a replacement
mitral valve.

- The patient has signed and dated the subject informed consent form prior to surgery.

- The patient is expected to survive the surgery and be discharged.

- The patient is geographically stable and agrees to attend follow-up assessments.

- The patient is 18 years or older.

Exclusion Criteria:

- The patient has any known non-cardiac life-threatening disease, which will limit the
patient's life expectancy below 1 year.

- The patient presents with active endocarditis within the last 3 months.

- The patient is pregnant or lactating.

- The patient is an intravenous drug abuser.

- The patient is currently a prison inmate.

- The patient is currently participating in a study of an investigational drug or
device.

- The patient requires replacement of a native or prosthetic tricuspid or pulmonic
valve.

- The patient requires replacement of a native or prosthetic aortic valve with a
prosthesis other than a commercially available Carpentier-Edwards PERIMOUNT Valve
(i.e. models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 3300TFX)*.

- The patient was previously enrolled in the study.

- The patient has had prior aortic, tricuspid and/or pulmonary valve surgery, which
included implantation of a bioprosthetic valve or mechanical valve that will remain in
situ.