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MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial) - United States | Clinical Trials | Clareo Health

TERMINATEDNA

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

NCT03311295•Mvrx, Inc.

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).

Eligibility

Age

21 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
+23 more criteria

Locations (1)

UC Davis Medical Center

Sacramento, California, United States

Key Dates

Start Date

April 3, 2018

Primary Completion Date

April 26, 2021

Completion Date

April 26, 2021

Last Updated

April 28, 2021

Enrollment

ACTUAL participants

Conditions

Mitral Valve Insufficiency

Interventions

ARTO System

DEVICE

DragonFly EU Pivotal Study

NCT05927441

Mitral Valve Insufficiency

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RECRUITINGNA

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

NCT03142152

Functional Mitral RegurgitationHeart Failure+4 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 28, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

DragonFly EU Pivotal Study

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population

Prognostic Impact of Imaging Parameters in Patients With Primary Mitral Insufficiency by Prolapse (COHORTE-IM)

The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study

The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study