HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve

Completed · Not applicable

Conditions studied: Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement

In brief

The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially available valves ranging in size from 16mm to 37mm. 20 subjects were enrolled as part of the IDE cohort and an additional 3 were enrolled under continued access.

Key facts

Study ID: NCT02097420
Run by: Abbott Medical Devices
People needed: 23
Starts: 2015-05-07
Expected to finish: 2023-07-01
Last updated by the study team: 2025-02-11

Who can join

Age: any, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject requires mitral valve replacement.*
Subject's legally authorized representative gives written consent to participate in the clinical study.
Subject is willing and able to return for data collection and follow-up for the duration of the clinical study.
Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study other than those noted in the exclusion criteria.

You may not qualify if…

1. Subject is > 5 years of age.
Subject has a contraindication to anticoagulant/antiplatelet medication.
Subject has a prosthetic valve(s) at a site other than the mitral valve prior to the study procedure.*
Subject requires concomitant replacement of the tricuspid, pulmonary, or aortic valve.
Subject has active endocarditis.
Subject has active myocarditis.
Subject has had an acute preoperative neurological deficit that has not returned to baseline or stabilized ≥ 30 days prior to the study procedure.
Subject has had an acute cardiac adverse event that has not returned to baseline or stabilized ≥48 hours prior to the study procedure.
Subject has a non-cardiac illness resulting in a life expectancy of < 1 year.
Subject has a known requirement for additional cardiac surgery within 12 months after the study procedure.
Subject has been previously enrolled and implanted in this study.
Subject is participating in another study for an investigational drug and/or device.
Subject has any other medical condition that in the opinion of the Investigator will interfere with the study results.
Subjects who have undergone a previous Ross procedure of the pulmonary valve are eligible for this study.
Continued Access Cohort-
Prospective Inclusion Criteria:
Subject requires mitral valve replacement.*
Subject's legally authorized representative gives written consent to participate in the clinical study.
Subject is willing and able to return for data collection and follow-up for the duration of the clinical study.
Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study.
Prospective Exclusion Criteria:
Subject is > 5 years of age.
Subject has a contraindication to anticoagulant/antiplatelet medication.
Retrospective Eligibility Criteria:
The subject must have been ≤ 5 years of age at the time of mitral valve replacement with the 15mm MHV.

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
Arkansas Children's Hospital — Little Rock, Arkansas, United States
Children's Hospital Los Angeles (USC) — Los Angeles, California, United States
University of California - Davis Medical Center — Sacramento, California, United States
Children's Hospital of Colorado — Aurora, Colorado, United States
Children's Healthcare of Atlanta — Atlanta, Georgia, United States
Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
Ochsner Medical Center — New Orleans, Louisiana, United States
Maine Medical Center — Portland, Maine, United States
University of Maryland School of Medicine — Baltimore, Maryland, United States
Boston Children's Hospital — Boston, Massachusetts, United States
Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
University of Minnesota Masonic Children's Hospital — Minneapolis, Minnesota, United States
University of Missouri-Kansas City School of Medicine — Kansas City, Missouri, United States
Children's Hospital & Medical Center — Omaha, Nebraska, United States
New York Presbyterian Hospital/Columbia University — New York, New York, United States
Levine Children's Hospital / Sanger Heart & Vascular Institute — Charlotte, North Carolina, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Texas Children's Hospital — Houston, Texas, United States
University of Utah Hospital — Salt Lake City, Utah, United States
University of Virginia Medical Center — Charlottesville, Virginia, United States
Seattle Children's Hospital — Seattle, Washington, United States
Sacred Heart Medical Center — Spokane, Washington, United States
West Virginia University Hospital — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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