Mitral Valve Insufficiency
Conditions
Brief summary
The objective of the study is to evaluate the safety and feasibility of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
Interventions
DEVICEARTO System
The ARTO System directly reshapes the mitral annulus promoting leaflet coaptation and amelioration of regurgitation.
Sponsors
Mvrx, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Major Adverse Event Rate to 30 Days post-procedure | 30 days post procedure | Major Adverse Events (MAEs) will be categorized and defined in accordance with the relation to the procedure and device. |
| Efficacy: Mitral regurgitation grade by ASE criteria and change from baseline to 1 year | Baseline to 1 year | Mitral regurgitation grade by ASE criteria and change from baseline to 1 year evaluated by 2-D transthoracic echocardiogram |
Countries
United States
Outcome results
None listed