Confirmation Trial of the Acorn CorCap Cardiac Support Device (CSD) at the Same Time as Mitral Valve Repair

The Acorn CorCap Cardiac Support Device (CSD) is a new therapy for the treatment of heart
failure that is designed to reduce left ventricular dilation, which is one of the most
important pathophysiological mechanisms underlying the clinical syndrome of heart failure.
The Acorn CorCap CSD is intended to reduce wall stress and support the heart, in order to
prevent further dilation that is associated with progressive heart failure. It is designed
to result in reduced left ventricular size and improve left ventricluar function, which
should result in improved patient functional status.

The purpose of the study is to provide confirmatory data to demonstrate an improved
benefit-risk profile in support of a Pre-Market Approval (PMA) application for the Acorn
CorCap CSD when placed concomitant to Mitral Valve Repair/Replacement (MVR).

The primary efficacy objective is to evaluate patient functional status after 6 months of
follow-up. The safety endpoint is perioperative (30 day) mortality.

Inclusion Criteria:

- Dilated cardiomyopathy of either ischemic or non-ischemic origin

- Patients must be on stable, optimally uptitrated medical therapy recommended
according to current guidelines as standard of care of heart failure therapy in the
United States. This minimally includes:

1. Angiotensin-converting enzyme inhibitors (ACE) or alternate if ACE not tolerated
for greater than or equal to 1 month prior to enrollment (not required for
patients with a mitral valve anomaly that is not likely to respond to medication
and requires surgical intervention).

2. Treatment with a beta-blocker, unless intolerant, for greater than or equal to 3
months prior to enrollment (not required for patients with a mitral valve
anomaly that is not likely to respond to medication and requires surgical
intervention).

3. Diuretic at least "prn" (as occasion requires).

4. Cardiac medications unchanged for greater than or equal to 1 month except for
diuretic adjustments (not required for patients with a mitral valve anomaly that
is not likely to respond to medications and requires surgical intervention).

- Adult (18 to 80 years).

- Indexed left ventricular end diastolic dimension (LVEDDi)between 30 mm/m2 and 40
mm/m2 as determined by transthoracic echocardiography.

- Mitral regurgitation (MR) greater than or equal to 2+ and scheduled for mitral valve
repair or replacement. Concomitant tricuspid valve repair or replacement (TVR) and/or
atrial fibrillation ablation procedures will be permitted.

- Left ventricular ejection fraction (LVEF) less than or equal to 45 percent via
transthoracic echocardiography, cardiac catheterization, radionuclide scan, or
magnetic resonance imaging

- New York Heart Association Functional Class (NYHA) II, III or IV

- Geographically available for follow-up

- Signed Informed Consent

Exclusion Criteria:

- Inability to reach maximal effort CPX test as defined by the CPX Core Lab

- Planned cardiac surgical procedure other than MVR

- Hypertrophic obstructive cardiomyopathy.

- Significant cardiomegaly, which is estimated to exceed the largest available size of
CorCap CSD.

- Expectation of existing cardiothoracic adhesions that would cause an inability to
gain complete circumferential access to the heart.

- Existing patent CABG.

- Candidates for surgical revascularization as determined by an angiogram. Patients
with ischemic heart disease who have not had an angiogram within the past 3 years and
in whom lesions amenable to revascularization cannot be excluded should have a repeat
angiogram.

- Any condition considered a contraindication for extracorporeal circulation.

- Use of Intra aortic Balloon Pump (IABP), intravenous inotropic or vasoactive agents
within 30 days prior to enrollment. Pre-operative hemodynamic optimization with IABP,
IV inotropes or vasoactive agents may be permitted if it is scheduled to occur within
48 hours of planned index surgery.

- Current or anticipated need for left ventricular assist device (LVAD) or cardiac
replacement device.

- Anticipated need for heart transplant within the next two years.

- Acute myocardial infarction (AMI), unstable angina, or cerebral vascular accident
(CVA) or Transient Ischemic Attack (TIA) within past 3 months.

- Percutaneous coronary intervention (PCI) or transmyocardial laser revascularization
(TMR or PMR) within the past 3 months.

- Presence of arrhythmias causing hemodynamic instability, history of resuscitated
sudden death without subsequent treatment with implantable defibrillator or
amiodarone, or atrial fibrillation with a ventricular rate greater than 100 bpm on
medication.

- Co-morbid condition that reduces life expectancy to less than 1 year.

- Active infection.

- Pregnancy at the time of enrollment. (Women of child bearing potential must have a
negative serum pregnancy test within two weeks prior to enrollment, or be using
hormonal contraceptives or intrauterine devices.)

- Enrolled in another investigational study that would confound interpretation of trial
results.

- Patients who participated as control patients in the previous CorCap PMA randomized
trial.

- Unable to comply with protocol-required follow-up (as judged by primary investigator
or referring cardiologist).

- Late stage heart failure with increased surgical risk as defined by the presence of
four or more of the following:

1. LVEDD greater than 80 mm/m2

2. Resting systolic blood pressure (BP) less than or equal to 80 mm Hg (on clinical
exam)

3. Atrial fibrillation at time of enrollment or paced rhythm with underlying atrial
fibrillation

4. Heart failure greater than or equal to 8 years

5. 6 minute walk less than or equal to 350 meters (1148 feet)

6. POV2 less than or equal to 13 ml/kg/min (CPX test)

7. Exercise induced increase in systolic BP less than 10 percent (CPX test)

8. Previous cardiac surgery

9. BUN greater than 100 mg/dl

10. Cachexia (clinical impression)