| Eligibility |
Inclusion Criteria:
Candidates must meet ALL of the following criteria to be enrolled in the study.
- Is ambulatory, able and willing to comply with the study protocol and has provided
written informed consent
- Age 21-85, inclusive
- Trans-septal catheterization is determined to be feasible by the treating physician
- NYHA class II-IV heart failure of any etiology
- Symptomatic with MR grade = 2+
- LVEF < 40%
- LVEDD > 50 mm and = 75 mm
- No anticipated change in patient's cardiac medication regimen anticipated throughout
the course of the study.
- In the opinion of the investigator and heart surgery team, the patient is not an
appropriate candidate for surgery, and the use of the ARTO System is technically
feasible
Exclusion Criteria:
Candidates will be excluded from enrollment in the study if ANY of the following conditions
apply.
- In the opinion of the Investigator, the femoral vein and internal jugular vein cannot
accommodate a 16 F catheter or the presence of an inferior vena cava (IVC) filter
would interfere with advancement of the catheter or ipsilateral DVT is present
- Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet
calcification)
- Significant mitral annular calcification
- Hemodynamic instability (systolic pressure < 90 mmHg without afterload reduction or
cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)
- Prior mitral valve surgery or valvuloplasty or any currently implanted prosthetic
valve or VAD
- History of, or active, rheumatic heart disease
- History of Atrial Septal Defects (ASD), whether repaired or not
- History of previously repaired PFO or PFO associated with clinical symptoms (e.g.,
cerebral ischemia) within 6 months of the planned investigational procedure
- In the opinion of the investigator, an atrial septal aneurysm is present that may
interfere with transseptal crossing
- Serum creatinine > 2.5 mg/dL or dialysis dependent
- No access to coronary sinus and/or great cardiac vein
- Platelet count < 100 x 103 cells/mm3
- Evidence of active infection (fever with temperature > 38°C and/or WBC > 15,000) or
endocarditis
- Echocardiographic evidence of mass intracardiac thrombus
- Patients on prescribed dual antiplatelet therapy (asprin + any P2Y12 inhibitor) that
cannot be discontinued.
- Percutaneous coronary intervention or surgery anticipated within the 6 month follow up
period following the investigational procedure
- Biventricular pacing initiated or anticipated within 6 months of the planned
investigational procedure
- Evidence of an acute myocardial infarction within 12 weeks of the planned
investigational procedure
- Stroke or TIA within 6 months of the planned investigational procedure
- GI bleeding within 6 months of the planned investigational procedure
- Intravenous drug abuse or suspected inability to adhere to follow-up
- Patients in whom TTE, TEE or ICE is contraindicated
- Contraindication to CT scan
- A known hypersensitivity or contraindication to study or procedure medications
(specifically aspirin, clopidogrel and heparin) that cannot be adequately managed
medically
- A known allergy or hypersensitivity to nickel
- A known need for any other cardiac surgery including surgery for coronary artery
disease, atrial fibrillation, pulmonic, aortic or tricuspid valve disease
- In the judgment of the Investigator, patients in whom the presence of a permanent
pacemaker or pacing leads would interfere with placement of the test device or the
placement of the test device would disrupt the leads
- Irreversible bleeding disorder, history of bleeding diathesis or coagulopathy or
refuses blood transfusion
- Evidence of disease or condition expected to compromise survival (< 1 year) or ability
to complete follow-up assessments
- Pregnant or breastfeeding women
- Currently participating in an investigational drug or another device study that has
not completed the primary endpoint or that clinically interferes with the current
study endpoints. [Note: Trials requiring extended follow-up for products that were
investigational, but have since become commercially available, are not considered
investigational trials]
- Patient not a candidate for emergent surgical bailout in case of need
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