MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study

Mitral Regurgitation (MR) is the most common valvular pathology affecting
several million people in Europe alone. The symptoms associated with MR are
congestive heart failure as well as symptoms suggestive of a low cardiac output
state. Available medical therapy is suboptimal and for most symptomatic
patients surgical intervention is the therapy of choice. Current guidelines
usually recommend surgical repair over replacement, due to more favorable
outcomes when the native valve is preserved.
The morbidity and mortality of surgical approaches have led to development of
less invasive method to treating MR. Considerable segment of the patients
suffering from severe functional MR (grade *3+) with impaired left ventricular
function are considered at high risk for surgery and therefore percutaneous
solution should be considered.

The study is designed to clinically demonstrate device acute safety (Primary
Endpoint) along with longer FU device safety and effectiveness evaluation
(Secondary Endpoint).
The main objectives of the study areU :
1) Evaluate the Acute safety of the implanted Mistral device post procedure and
at 30 day follow up period.
2)Evaluate the long term Safety of the device (3 and 6 months follow up).
3)Demonstrate effectiveness of the Mistral device in improving MR.

Study describes a prospective, multicenter, single arm, uncontrolled,
non-randomized, enrolling patients with moderate-severe functional MR who are
at high risk for surgery, and in whom existing co-morbidities would not
preclude the expected benefit from correction of the mitral regurgitation.

Access:
* Trans-septal (TS) access is performed through the femoral vein.
* TS puncture is performed in accordance with IFU.
* Agilis guiding introducer inserted into the left atrium (LA).
* The Mistral Delivery System (MDS) is inserted through the Agilis into
LA.


Implantation Procedure:
* Positioning of the MDS tip and deployment of the spiral in the LA is
performed under echocardiography and fluoroscopy.
* The MDS with the deployed Mistral are steered and forwarded across the
mitral valve into the LV.
* The Mistral is located at required position: Above one of the papillary
muscles, and between the papillary muscle end and the leaflets tips.
* After positioning the Mistral is rotated, up to maximum of 3.5
rotations, for chordae grasping under echo guidance.
* During positioning and rotations Mistral may be rotated backwards, as
required.
* After assessment of device position, chordae grasping quality and
mitral regurgitation improvement * the device is released from MDS.
* MDS is retrieved out of the body.
* Patient is prepared for ending the procedure.

The risks involved in participation in the study are standard risks associated
with general anesthesia, echocardiography examination, use of radiographic
contrast, cardiac catheterization and procedural medications along with the
risks related to the implant device and the delivery system.
The possible additional risks of going through the procedure are as follows:

1. Allergic reaction (nickel- titanium alloy, Stainless steel, ABS plastic)
2. Aneurysm or pseudo-aneurysm
3. Arrhythmias
4. Atrial septal defect requiring intervention
5. Arterio-venous fistula
6. Bleeding
7. Cardiac perforation
8. Cardiac temponade/Pericardial Effusion
9. Coagulopathy
10. Conversion to standard valve surgery
11. Death
12. Dislodgement of previously implanted devices
13. Drug reaction to anti-platelet/anticoagulation agents/contrast media
14. Emboli (air, thrombus, Mistral Implant)
15. Emergency cardiac surgery
16. Endocarditis
17. Failure to retrieve Mistral System components
18. Hemolysis
19. MDS component(s) embolization
20. Mesenteric ischemia
21. Mistral migration or malposition
22. Mistral Device thrombosis
23. Mitral stenosis
24. Mitral valve injury
25. Prolonged angina
26. Prolonged ventilation
27. Pulmonary congestion
28. Pulmonary thrombi-embolism
29. Septicemia
30. Stroke or transient ischemic attack (TIA)
31. Vessel perforation or laceration
32. Worsening heart failure
33. Worsening mitral regurgitation

As with every new product new and to date unknown side effects may occur during
the treatment with Mistral.