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

MVRx, Inc.

Status

Terminated

Conditions

Mitral Valve Insufficiency

Treatments

Device: ARTO System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03311295

US042616

Details and patient eligibility

About

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).

Enrollment

1 patient

Sex

All

Ages

21 to 85 years old

Volunteers

No Healthy Volunteers

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