Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation

Not Applicable

• Conditions: Mitral Valve Regurgitation
• Interventions: Device: ARTO System

• Registration Number: NCT02302872
• Lead Sponsor: Mvrx, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-27
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-07
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARTO system	ARTO System	-

Primary Outcome Measures

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

Trial Locations

Locations (9)

Pauls Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

The Wesley Hospital; 🇦🇺 Auchenflower, Queensland, Australia

ICPS; 🇫🇷 Massy, France

Warringal Private Hospital; 🇦🇺 Heidelberg, Australia

The Mount Hospital; 🇦🇺 Perth, Australia

Brighton and Sussex University Hospitals; 🇬🇧 Brighton, United Kingdom

IRCCS San Donato; 🇮🇹 Milan, Italy

St Andrews Hospital; 🇦🇺 Adelaide, South Australia, Australia

St Thomas' Hospital; 🇬🇧 London, United Kingdom