Clinical trial NCT02302872: Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation
Official title: Mitral Valve Repair Clinical Trial (MAVERIC Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Valve Regurgitation
Lead sponsor: Mvrx, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-27
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Event Rate to 30 Days post-procedure
timeFrame: <=30 days post procedure
measure: Mitral regurgitation grade and change from baseline to 30 days
timeFrame: <=30 days post procedure
measure: Device Technical Success
timeFrame: procedural
Secondary outcomes:
Other outcomes:
Locations:
city: Auchenflower
country: Australia
facility: The Wesley Hospital
state: Queensland
city: Adelaide
country: Australia
facility: St Andrews Hospital
state: South Australia
city: Heidelberg
country: Australia
facility: Warringal Private Hospital
city: Perth
country: Australia
facility: The Mount Hospital
city: Massy
country: France
facility: ICPS
city: Milan
country: Italy
facility: IRCCS San Donato
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals
city: London
country: United Kingdom
facility: St Thomas' Hospital
Study officials:
affiliation: Pauls Stradins Clinical University Hospital
name: Andrejs Erglis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.