Mitral Valve Regurgitation
Conditions
Brief summary
The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
Interventions
DEVICEARTO System
Sponsors
Mvrx, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent 2. Age ≥ 18 3. Trans-septal catheterization is determined to be feasible by the treating physician 4. NYHA class II-IV heart failure of any etiology 5. Symptomatic with MR grade ≥ 2+ 6. LVEF ≥20% ≤ 50% 7. LVEDD \> 50 mm and ≤ 70 mm 8. No anticipated change in patient's cardiac medication regimen anticipated throughout the course of the study. 9. • In the opinion of the investigator and heart surgery team, the patient is not a candidate for surgery, and the use of the ARTO™ System is technically feasible.
Exclusion criteria
1. 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 2. Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet calcification) 3. Significant mitral annular calcification 4. Hemodynamic instability (systolic pressure \< 90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump) 5. Prior mitral valve surgery or valvuloplasty or any currently implanted prosthetic valve or VAD 6. History of, or active, rheumatic heart disease 7. History of Atrial Septal Defects (ASD), whether repaired or not 8. History of previously repaired PFO or PFO associated with clinical symptoms (e.g., cerebral ischemia) within 6 months of the planned investigational procedure 9. In the opinion of the investigator, an atrial septal aneurysm is present that may interfere with transseptal crossing 10. Biventricular pacing initiated or anticipated within 6 months of the planned investigational procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Event Rate to 30 Days post-procedure | <=30 days post procedure | Major Adverse Events defined as: death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure |
| Mitral regurgitation grade and change from baseline to 30 days | <=30 days post procedure | — |
| Device Technical Success | procedural | At exit from cath lab, alive, with Successful access, delivery and retrieval of the device delivery system, and Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure |
Countries
Australia, France, Italy, Latvia, United Kingdom
Outcome results
None listed