Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation

Mitral Valve Regurgitation Clinical Trial

— MAVERIC  

Official title:

Mitral Valve Repair Clinical Trial (MAVERIC Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02302872
• Other study ID #: EU010513, AU220816
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2013
• Est. completion date: September 2021

Study information

• Verified date: April 2021
• Source: Mvrx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: September 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• ARTO System

Locations

Country	Name	City	State
Australia	St Andrews Hospital	Adelaide	South Australia
Australia	The Wesley Hospital	Auchenflower	Queensland
Australia	Warringal Private Hospital	Heidelberg
Australia	The Mount Hospital	Perth
France	ICPS	Massy
Italy	IRCCS San Donato	Milan
Latvia	Pauls Stradins Clinical University Hospital	Riga
United Kingdom	Brighton and Sussex University Hospitals	Brighton
United Kingdom	St Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Mvrx, Inc.

Countries where clinical trial is conducted

Australia,  France,  Italy,  Latvia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Event Rate to 30 Days post-procedure	Major Adverse Events defined as: death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure	<=30 days post procedure
Primary	Mitral regurgitation grade and change from baseline to 30 days		<=30 days post procedure
Primary	Device Technical Success	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	procedural