Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation

NCT02302872 | Unknown DMC

• 1 other identifier: EU010513, AU220816
• Study Type: interventional
• Target: 51
• Locations: 5 countries
• Sites: 9

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).

Conditions

Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (3)

• 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

• Mitral regurgitation grade and change from baseline to 30 days

  <=30 days post procedure

• 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

Study Arms (1)

ARTO system

EXPERIMENTAL

Device: ARTO System

Interventions

ARTO System DEVICE

ARTO system

Eligibility Criteria

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

You may qualify if:

• Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
• Age ≥ 18
• 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 ≥20% ≤ 50%
• LVEDD \> 50 mm and ≤ 70 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 a candidate for surgery, and the use of the ARTO™ System is technically feasible.

You may not qualify if:

• 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
• Biventricular pacing initiated or anticipated within 6 months of the planned investigational procedure

Sponsors & Collaborators

• Mvrx, Inc.: lead

Study Sites (9)

The Wesley Hospital

Auchenflower, Queensland, 4066, Australia

Location

St Andrews Hospital

Adelaide, South Australia, 5000, Australia

Location

Warringal Private Hospital

Heidelberg, Australia

Location

The Mount Hospital

Perth, Australia

Location

ICPS

Massy, France

Location

IRCCS San Donato

Milan, Italy

Location

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Brighton and Sussex University Hospitals

Brighton, United Kingdom

Location

St Thomas' Hospital

London, United Kingdom

Location

Related Publications (2)

• Erglis A, Narbute I, Poupineau M, Hovasse T, Kamzola G, Zvaigzne L, Erglis M, Erglis K, Greene S, Rogers JH. Treatment of Secondary Mitral Regurgitation in Chronic Heart Failure. J Am Coll Cardiol. 2017 Dec 5;70(22):2834-2835. doi: 10.1016/j.jacc.2017.09.1110. No abstract available.

  PMID: 29191334 DERIVED

• Rogers JH, Thomas M, Morice MC, Narbute I, Zabunova M, Hovasse T, Poupineau M, Rudzitis A, Kamzola G, Zvaigzne L, Greene S, Erglis A. Treatment of Heart Failure With Associated Functional Mitral Regurgitation Using the ARTO System: Initial Results of the First-in-Human MAVERIC Trial (Mitral Valve Repair Clinical Trial). JACC Cardiovasc Interv. 2015 Jul;8(8):1095-1104. doi: 10.1016/j.jcin.2015.04.012. Epub 2015 Jun 24.

  PMID: 26117461 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Andrejs Erglis, MD

  Pauls Stradins Clinical University Hospital

  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: November 18, 2014
• First Posted: November 27, 2014
• Study Start: October 1, 2013
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

IT (1); AU (4); LA (1); GB (2); FR (1)