MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial) - United States



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - 85
Updated:7/20/2018
Start Date:April 3, 2018
End Date:April 3, 2024
Contact:Samantha Greene
Email:sgreene@mvrxinc.com
Phone:949 910 8948

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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).


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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Sacramento, California 95814
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