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

NCT03311295 | Terminated DMC FDA Device

• 1 other identifier: US042616
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (2)

• Safety: Major Adverse Event Rate to 30 Days post-procedure

  Major Adverse Events (MAEs) will be categorized and defined in accordance with the relation to the procedure and device.

  30 days post procedure

• Efficacy: Mitral regurgitation grade by ASE criteria and change from baseline to 1 year

  Mitral regurgitation grade by ASE criteria and change from baseline to 1 year evaluated by 2-D transthoracic echocardiogram

  Baseline to 1 year

Study Arms (1)

ARTO System

EXPERIMENTAL

Device: ARTO System

Interventions

ARTO System DEVICE

The ARTO System directly reshapes the mitral annulus promoting leaflet coaptation and amelioration of regurgitation.

ARTO System

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mvrx, Inc.: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Reginald Low, MD

  University California Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 17, 2017
• Study Start: April 3, 2018
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

US (1)